Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12620000864921
Ethics application status
Approved
Date submitted
30/06/2020
Date registered
31/08/2020
Date last updated
31/08/2020
Date data sharing statement initially provided
31/08/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
The Noisy Guts Project: Can we use analysis of gut sounds to accurately diagnose different gut conditions?
Scientific title
A combined data gathering and diagnostic test accuracy study to test the feasibility of using an acoustic belt for differential diagnosis of gastrointestinal diseases and disorders.
Secondary ID [1] 301652 0
NHMRC 1179049
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Irritable bowel syndrome 318075 0
Crohn's disease 318076 0
Ulcerative colitis 318077 0
Coeliac disease 318078 0
Condition category
Condition code
Oral and Gastrointestinal 316107 316107 0 0
Inflammatory bowel disease
Oral and Gastrointestinal 316108 316108 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Oral and Gastrointestinal 316420 316420 0 0
Crohn's disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Sound Recordings
All participants will undergo a single session of recordings with the acoustic belt. The intervention is the same for both stages of the study: the data gathering and the diagnostic test accuracy study. Further, the intervention is also the same for participants with all conditions: irritable bowel syndrome (IBS), Crohn's disease, ulcerative colitis and coealiac disease. The sound recordings take place within three weeks of the initial endoscopic review that forms part of the reference standard.

The participants fast overnight (no food from 9pm, no water except to take medications from midnight) and commence the recordings at around 9am. They sit and wear the belt whilst bowel sounds are recorded, first for 2 hours and then for 40 minutes after a short break of no more than 15 minutes. At the start of the second recording they consume a standard meal consisting of a (low–lactose SUSTAGEN (Registered Trademark) OPTIMUM (Trademark) shake and small glass of water). Participants may read, or surf the internet whilst wearing the belt.

Our acoustic belt, worn around the abdomen, consists of four sensor heads with microphones held in place by a soft Tubigrip (Registered Trademark) bandage. The sensors are attached to a recording unit with a very low voltage battery. These belts have previously been used safely and effectively for another study to gather data and test a model for differentiation between IBS and healthy gut sounds.

The recorded sounds are then transferred to a desktop for analysis. The recordings are processed to remove background noise, plus heart and breathing sounds and speech. The bowel sounds are extracted and then physical features of the bowel sounds.

Rome IV Criteria
At the time of recordings, all participants will also complete a diagnostic questionnaire, The Rome IV criteria, which consists of six multi-choice questions about their abdominal symptoms.

The intervention is administered by a trained member of the team who aids with fitting of the belt, timing of recordings, provision of the Rome IV questionnaire, plus meal preparation and provision. To monitor adherence and data quality, all stages of the intervention are recorded are checked off on a tick-sheet and recordings are checked for quality (i.e. duration and all sensors recording) prior to processing and analysis.
Intervention code [1] 317959 0
Diagnosis / Prognosis
Intervention code [2] 317962 0
Early detection / Screening
Comparator / control treatment
Reference Standard
All participants will undergo routine clinical investigation of their gastrointestinal condition via their Gastroenterologist as part of their routine care. This includes reviewing the patients’ history, plus blood and stool test results provided with the referral or from tests conducted after referral. The typical tests are microbiology, complete blood count, C-reactive protein, faecal calprotectin, serology testing for coeliac disease, and faecal occult blood test. All participants will also undergo endoscopic review. This will be shortly before referral by the hospital team. Patients with predominant diarrhoea symptoms will also have a biopsy with histological review at the time of colonoscopy. The Gastroenterologists will provide the clinical diagnosis, and the endoscopy/colonoscopy and pathology test results for analysis.

The clinical diagnosis provided by the gastroenterologists, and confirmed by the results of colonoscopy, provides the labelling of each participant (allocation to GI condition group) for the participants involved in the data gathering stage of the study.

For the diagnsotic test accurcy study part of the study the reference standards are the clinical diagnosis provided by the gastroenterologists, confirmed by the results of colonoscopy for each of the conditions.

The sound recordings occur within 3 weeks of the initial endoscopic review. The pathology test results included will be from tests typically undertaken in the 6 months before or 1 month after the endoscopic review. i.e, those used by the gastroenerologist to make their diagnosis.
Control group
Active

Outcomes
Primary outcome [1] 324297 0
Our primary outcome is sensitivity in detecting Crohn’s disease amongst the blind testing sample containing participants with IBS and Crohn’s disease. The true positive rate for Crohn's disease will be assessed for the Noisy Guts belt prediction when compared to the reference standard (clinical diagnosis by the gastroenterologist confirmed by colonoscopy results).
This is key to determining if the test is suitable as a screening test for Crohn’s.


Timepoint [1] 324297 0
Assessment will occur after all participant recordings have been collected and analysed. The confirmed clinical diagnosis (reference standard) is derived retrospectively from medical records.
Secondary outcome [1] 384272 0
Overall accuracy in detecting Crohn's disease amongst the blind testing sample containing participants with IBS and Crohn's disease. The true positive and negative rates for Crohn's disease will be assessed for the Noisy Guts belt prediction when compared to the reference standard (clinical diagnosis by the gastroenterologist confirmed by colonoscopy results).
Timepoint [1] 384272 0
Assessment will occur after all participant recordings have been collected and analysed. The confirmed clinical diagnosis (reference standard) is derived retrospectively from medical records.
Secondary outcome [2] 385085 0
Specificity in detecting Crohn’s disease amongst the blind testing sample containing participants with IBS and Crohn’s disease. The true negative rate for Crohn's disease will be assessed for the Noisy Guts belt prediction when compared to the reference standard (clinical diagnosis by the gastroenterologist confirmed by colonoscopy results).
Timepoint [2] 385085 0
Assessment will occur after all participant recordings have been collected and analysed.. The confirmed clinical diagnosis (reference standard) is derived retrospectively from medical records.
Secondary outcome [3] 385088 0
The negative predictive value (NPV) for detecting Crohn's disease amongst the sample containing participants with IBS and Crohn's disease. We will calulate the rate at which participants with a negative result from the Noisy Guts belt truly don't have Crohn's disease based on the reference standard (clinical diagnosis by the gastroenterologist confirmed by colonoscopy results).
Timepoint [3] 385088 0
Assessment will occur after all participant recordings have been collected and analysed.. The confirmed clinical diagnosis is derived retrospectively from medical records.
Secondary outcome [4] 385089 0
The positive predictive value (PPV) for detecting Crohn's disease amongst the sample containing participants with IBS and Crohn's disease. We will calculate the rate at which participants with a positive result from the Noisy Guts belt truly have Crohn's disease based on the reference standard (clinical diagnosis by the gastroenterologist confirmed by colonoscopy results).
Timepoint [4] 385089 0
Assessment will occur after all participant recordings have been collected and analysed. The confirmed clinical diagnosis is derived retrospectively from medical records.
Secondary outcome [5] 385090 0
Sensitivity in detecting IBS amongst the blind testing sample containing participants with IBS and organic diseases (Crohn's disease, ulcerative colitis or coeliac disease). The true positive rate for IBS will be assessed for the Noisy Guts belt prediction when compared to the reference standard (clinical diagnosis by the gastroenterologist confirmed by colonoscopy results).
Timepoint [5] 385090 0
Assessment will occur after all participant recordings have been collected and analysed. The confirmed clinical diagnosis is derived retrospectively from medical records.
Secondary outcome [6] 385091 0
Specificity in detecting IBS amongst the blind testing sample. The true negative rate for IBS will be assessed for the Noisy Guts belt prediction when compared to the reference standard (clinical diagnosis by the gastroenterologist confirmed by colonoscopy results).
Timepoint [6] 385091 0
Assessment will occur after all participant recordings have been collected and analysed.. The confirmed clinical diagnosis is derived retrospectively from medical records.
Secondary outcome [7] 385092 0
Overall accuracy in detecting IBS amongst the blind testing sample. The true positive and negative rates for IBS will be assessed for the Noisy Guts belt prediction when compared to the reference standard (clinical diagnosis by the gastroenterologist confirmed by colonoscopy results).
Timepoint [7] 385092 0
Assessment will occur after all participant recordings have been collected and analysed. The confirmed clinical diagnosis is derived retrospectively from medical records.
Secondary outcome [8] 385093 0
The positive predictive value (PPV) for detecting IBS amongst the blind testing sample. We will calculate the rate at which participants with a positive result from the Noisy Guts belt truly have IBS based on the reference standard (clinical diagnosis by the gastroenterologist confirmed by colonoscopy results).
Timepoint [8] 385093 0
Assessment will occur after all participant recordings have been collected and analysed.. The confirmed clinical diagnosis is derived retrospectively from medical records.
Secondary outcome [9] 385094 0
The negative predictive value (NPV) for detecting IBS amongst the blind testing sample. We will calulate the rate at which participants with a negative result from the Noisy Guts belt truly don't have IBS based on the reference standard (clinical diagnosis by the gastroenterologist confirmed by colonoscopy results).
Timepoint [9] 385094 0
Assessment will occur after all participant recordings have been collected and analysed. The confirmed clinical diagnosis is derived retrospectively from medical records.
Secondary outcome [10] 385095 0
Sensitivity in detecting ulcerative colitis amongst the blind testing sample containing participants with IBS and ulcerative colitis. The true positive rate for ulcerative colitis will be assessed for the Noisy Guts belt prediction when compared to the reference standard (clinical diagnosis by the gastroenterologist confirmed by colonoscopy results).
Timepoint [10] 385095 0
Assessment will occur after all participant recordings have been collected and analysed. The confirmed clinical diagnosis is derived retrospectively from medical records.
Secondary outcome [11] 385096 0
Specificity in detecting ulcerative colitis amongst the blind testing sample containing participants with IBS and ulcerative colitis. The true negative rate for ulcerative colitis will be assessed for the Noisy Guts belt prediction when compared to the reference standard (clinical diagnosis by the gastroenterologist confirmed by colonoscopy results).
Timepoint [11] 385096 0
Assessment will occur after all participant recordings have been collected and analysed.. The confirmed clinical diagnosis is derived retrospectively from medical records.
Secondary outcome [12] 385097 0
Overall accuracy in detecting ulcerative colitis amongst the blind testing sample containing participants with IBS and ulcerative colitis. The true positive and negative rates for ulcerative colitis will be assessed for the Noisy Guts belt prediction when compared to the reference standard (clinical diagnosis by the gastroenterologist confirmed by colonoscopy results).
Timepoint [12] 385097 0
Assessment will occur after all participant recordings have been collected and analysed. The confirmed clinical diagnosis is derived retrospectively from medical records.
Secondary outcome [13] 385098 0
Sensitivity in detecting coeliac disease amongst the blind testing sample containing participants with IBS and coeliac disease. The true positive rate for coeliac disease will be assessed for the Noisy Guts belt prediction when compared to the reference standard (clinical diagnosis by the gastroenterologist confirmed by colonoscopy and histology results).
Timepoint [13] 385098 0
Assessment will occur after all participant recordings have been collected and analysed. The confirmed clinical diagnosis is derived retrospectively from medical and pathology records.
Secondary outcome [14] 385099 0
Specificity in detecting coeliac disease amongst the blind testing sample containing participants with IBS and coeliac disease. The true negative rate for coeliac disease will be assessed for the Noisy Guts belt prediction when compared to the reference standard (clinical diagnosis by the gastroenterologist confirmed by colonoscopy and histology results).
Timepoint [14] 385099 0
Assessment will occur after all participant recordings have been collected and analysed. The confirmed clinical diagnosis (reference standard) is derived retrospectively from medical records.
Secondary outcome [15] 385100 0
Overall accuracy in detecting coeliac disease amongst the blind testing sample containing participants with IBS and coeliac disease. The true positive and negative rates for coeliac disease will be assessed for the Noisy Guts belt prediction when compared to the reference standard (clinical diagnosis by the gastroenterologist confirmed by colonoscopy and histology results).
Timepoint [15] 385100 0
Assessment will occur after all participant recordings have been collected and analysed.
The confirmed clinical diagnosis is derived retrospectively from medical records.
Secondary outcome [16] 385101 0
The negative predictive value (NPV) for detecting coeliac disease amongst the sample containing participants with IBS and coeliac disease. We will calulate the rate at which participants with a negative result from the Noisy Guts belt truly don't have coeliac disease based on the reference standard (clinical diagnosis by the gastroenterologist confirmed by colonoscopy and histology results).
Timepoint [16] 385101 0
Assessment will occur after all participant recordings have been collected and analysed.. The confirmed clinical diagnosis is derived retrospectively from medical records.
Secondary outcome [17] 385102 0
The positive predictive value (PPV) for detecting coeliac disease amongst the sample containing participants with IBS and coeliac disease. We will calculate the rate at which participants with a positive result from the Noisy Guts belt truly have coeliac disease based on the reference standard (clinical diagnosis by the gastroenterologist confirmed by colonoscopy and histology results).
Timepoint [17] 385102 0
Assessment will occur after all participant recordings have been collected and analysed. The confirmed clinical diagnosis is derived retrospectively from medical records.
Secondary outcome [18] 385105 0
The negative predictive value (NPV) for detecting ulcerative colitis amongst the sample containing participants with IBS and ulcerative colitis. We will calulate the rate at which participants with a negative result from the Noisy Guts belt truly don't have ulcerative colitis based on the reference standard (clinical diagnosis by the gastroenterologist confirmed by colonoscopy results).
Timepoint [18] 385105 0
Assessment will occur after all participant recordings have been collected and analysed. The confirmed clinical diagnosis is derived retrospectively from medical records.
Secondary outcome [19] 385107 0
The positive predictive value (PPV) for detecting ulcerative colitis amongst the sample containing participants with IBS and ulcerative colitis. We will calculate the rate at which participants with a positive result from the Noisy Guts belt truly have ulcerative colitis based on the reference standard (clinical diagnosis by the gastroenterologist confirmed by colonoscopy results).
Timepoint [19] 385107 0
Assessment will occur after all participant recordings have been collected and analysed. The confirmed clinical diagnosis is derived retrospectively from medical records.
Secondary outcome [20] 385115 0
Overall accuracy in detecting Crohn's disease amongst the training data set containing participants with IBS and Crohn's disease based on Leave Out Cross Validation Results for the optimised model. The true positive and negative rates for Crohn's disease will be assessed for the Noisy Guts belt prediction when compared to the reference standard (clinical diagnosis by the gastroenterologist confirmed by colonoscopy results).
Timepoint [20] 385115 0
Assessment will occur after all the training dataset participant recordings have been collected and analysed. The confirmed clinical diagnosis is derived retrospectively from medical records.
Secondary outcome [21] 385116 0
Overall accuracy in detecting IBS amongst the training data set based on Leave Out Cross Validation Results for the optimised model. The true positive and negative rates for IBS will be assessed for the Noisy Guts belt prediction when compared to the reference standard (clinical diagnosis by the gastroenterologist confirmed by colonoscopy results).
Timepoint [21] 385116 0
Assessment will occur after all training dataset participant recordings have been collected and analysed.The confirmed clinical diagnosis is derived retrospectively from medical records.
Secondary outcome [22] 385117 0
Overall accuracy in detecting coeliac disease amongst the training data set containing participants with IBS and coeliac disease based on Leave Out Cross Validation Results for the optimised model. The true positive and negative rates for coeliac disease will be assessed for the Noisy Guts belt prediction when compared to the reference standard (clinical diagnosis by the gastroenterologist confirmed by colonoscopy and histology results).
Timepoint [22] 385117 0
Assessment will occur after all the training dataset participant recordings have been collected and analysed. The confirmed clinical diagnosis is derived retrospectively from medical records.
Secondary outcome [23] 385118 0
Overall accuracy in detecting ulcerative colitis amongst the training data set containing participants with IBS and ulcerative colitis based on Leave Out Cross Validation Results for the optimised model. The true positive and negative rates for ulcerative colitis will be assessed for the Noisy Guts belt prediction when compared to the reference standard (clinical diagnosis by the gastroenterologist confirmed by colonoscopy results).
Timepoint [23] 385118 0
Assessment will occur after all the training dataset participant recordings have been collected and analysed. The confirmed clinical diagnosis is derived retrospectively from medical records.

Eligibility
Key inclusion criteria
Data gathering stage
Patients presenting for first investigation of lower gastrointestinal symptoms with a gastroenterologist, who receive a diagnosis of coeliac disease (confirmed via distal duodenal biopsy after positive serology), Crohn’s disease or ulcerative colitis (confirmed via Upper GI endoscopy, or colonoscopy or sigmoidoscopy and biopsy).

Diagnostic Test Accuracy study
Additional inclusion criteria for the DTA study: Patients presenting for first investigation of lower gastrointestinal symptoms with a gastroenterologist, who receive a diagnosis of IBS (confirmed through colonoscopy negative for organic disease), Crohn’s disease, colitis or coeliac disease (confirmed as above).
Minimum age
18 Years
Maximum age
50 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
We will exclude participants with a learning disability of poor understanding of English, which means they are unable to provide informed consent or understand the Rome IV symptom criteria questions.

We will exclude individuals with a severe allergy to milk proteins (not lactose) or soy.

We will also exclude individuals who have been diagnosed with the following conditions: cancer anywhere in the GI tract, current infection of the GI tract, HIV infection, diabetes or an eating disorder. We will also exclude those with neurological disease or damage that may impair gastrointestinal motility. We will exclude individuals who are pregnant, who have undergone bariatric surgery or resection of any part of their bowels and those regularly taking high doses of NSAIDs or opiates. These factors all affect sounds from the abdomen.

Participants who cannot undertake the recording visit within 3 weeks from the gastroenterologist’s preliminary diagnosis or who fail to fast or complete recordings, e.g., due to displaying respiratory symptoms, will also be excluded.

In most cases the preliminary diagnosis will match the final diagnosis provided by the gastroenterologist. In rare cases the histology results may lead to a participant moving between gastrointestinal conditions or being excluded.

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?

The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Other
Other design features
Study Design
The project involves two stages. We will first gather recordings and use them to build models that characterise the various GI conditions based on the GI sounds. Next, we will test the accuracy of these models. This will be through a diagnostic test accuracy (DTA) study including patients newly referred to gastroenterologists from GPs or Emergency Departments for investigation of lower GI symptoms.

Patients from a single cohort, all undertake the reference standard (clinical investigation and scoping). Subsequently, participants with IBS, coeliac disease, Crohn’s disease and ulcerative colitis from the cohort undergo the new index (sound) test. The results of the two are compared to arrive at measures of accuracy for the index test. Gastroenterologists target consecutive patients for recruitment until target numbers are met for each condition, so as to reduce spectrum bias.

Timeline
We will recruit participants at the time of preliminary diagnosis just after scoping. Subsequently, the participants will undergo the new index (sound) test. We will also confirm the final diagnosis made by the gastroenterologist once any histology results have been provided. The results of the index test and the final diagnosis are compared to arrive at measures of accuracy for the index test.

Recruiting patients at the point of initial preliminary diagnosis reduces the number of index (sound) tests carried out, and the time difference between the reference standard and the index test without biasing diagnostic estimates. It also means that any participants with Crohns’ or colitis are less likely to have started on treatment, which may affect sounds.

Blinding
Once recruited, the participants will be allocated an ‘in-house’ identifier number. The key to the identifications will be kept in a password protected file. Belt fitters and data analysts at the Marshall Centre will be blind to the condition of the patient (reference standard) as they conduct the index test. The sound analysis itself is an objective and unbiased process undertaken by our algorithms. The output of the model for each participant will subsequently be compared to the confirmed clinical diagnosis by another researcher.

The reference standard will be conducted by the gastroenterologists blind to the index (sound based) test results.
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
Model building and internal cross-validation
Recordings from the first 75 participants in each group will be used to build a model for multi-class categorisation using a machine learning approach. The recordings are processed to extract the bowel sounds and then frequency domain and time domain features will be extracted from each bowel sound and the approximate location of origin of each bowel sound will be determined. The distribution of the individual features, including kurtosis and skew will also be calculated. These are combined with features previously extracted from recordings from IBS patients.

An iterative process is used to identify the optimal array of features most strongly associated with the classes. Choice of starting features will be driven by consideration of features found effective previously by the research team and consideration of features identified though our mathematical model of bowel sound generation as being linked to physical and motility properties of the bowel.

The model’s predictions will be compared to the prior clinical diagnosis (reference standard) for each participant to assess accuracy. The model will be fine-tuned using test results from leave one out cross validation (LOOCV) and other internal validation techniques. This iterative process will be repeated until accuracy plateaus.

Internal evaluation of the optimal model’s performance will be provided by the final LOOCV analysis, other k-fold cross-validation techniques and bootstrapping. The accuracy measures calculated at this interim point will be the will be overall accuracy, sensitivity and specificity (with confidence intervals), positive likelihood ratio, and negative likelihood ratio.

Independent testing
The diagnostic accuracy of the optimal model will subsequently be tested using an additional 124 participants. We will calculate overall accuracy, sensitivity and specificity (with confidence intervals), negative predictive value (NPV) positive predictive value (PPV), positive likelihood ratio, and negative likelihood ratio for the index test for IBS, Crohn’s disease, colitis and coeliac disease for each data set.
We will also assess the accuracy of the Rome IV criteria amongst the independent testing set.

We will investigate whether the accuracy of the test differs for older participants (over 45 years) vs younger participants, different sexes, healthy range vs high BMI, different ethnic groups. For the IBS group we will also assess if accuracy differs for the different subtypes of IBS, and for those meeting the Rome IV criteria. For these analyses we will employ Fisher exact tests and a significance level of 0.05. Analyses will be performed in R.

Additional analyses of the effectiveness of algorithms combining pathology results, Rome IV and sounds may be added, depending on the availability of this data. Similarly, we may stratify the Crohn’s and colitis results by severity and location, and look at the effects of medications.


Sample Size
Training
The sample sizes for data gathering and development of the models (n = 225) are shaped by our previous experience (where we typically used 35 per group). Similar numbers have been used successfully in the past for other proof-of-concept studies. This time we have multiple belts with standardised hardware, which removes confounding effects, but we are aiming for greater accuracy. Hence, the choice of 75 per class for the training data.

Testing
The sample sizes for independent testing the models are derived from our aim of achieving sensitivity higher than the Rome IV criteria for IBS and the typical benchmark of 70% for a screening test for organic disease. The required sample size is 31 participants per group, we will recruit 35 per group to accommodate drop out.


Study Power and Significance
The sample sizes for independent testing the models are derived from our aim of achieving sensitivity higher than the Rome IV criteria for IBS (62.7%) and the typical benchmark of 70% for a screening test for organic disease. We used tables derived from PASS software (Mohamad Adam Bujang, 2016).

For assessment of our primary outcome (and the other tests for differentiation between IBS and an organic disease) a minimum sample size of 31 participants per group (with equal numbers in each) will be required to achieve a minimum power of 80% for detecting a change in the percentage value of sensitivity of a test from 0.70 to 0.90 for Crohn’s disease, based on a target significance level of 0.05. We will recruit 35 participants to each group to accommodate drop out.



Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
7/09/2020
Actual
Date of last participant enrolment
Anticipated
26/03/2021
Actual
Date of last data collection
Anticipated
30/04/2021
Actual
Sample size
Target
365
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 17007 0
Sir Charles Gairdner Hospital - Nedlands
Recruitment hospital [2] 17008 0
Osborne Park Hospital - Stirling
Recruitment hospital [3] 17009 0
Fremantle Hospital and Health Service - Fremantle
Recruitment hospital [4] 17010 0
St John of God Hospital, Subiaco - Subiaco
Recruitment hospital [5] 17011 0
St John of God Hospital, Murdoch - Murdoch
Recruitment postcode(s) [1] 30670 0
6009 - Nedlands
Recruitment postcode(s) [2] 30671 0
6021 - Stirling
Recruitment postcode(s) [3] 30672 0
6160 - Fremantle
Recruitment postcode(s) [4] 30673 0
6008 - Subiaco
Recruitment postcode(s) [5] 30674 0
6150 - Murdoch

Funding & Sponsors
Funding source category [1] 306086 0
Government body
Name [1] 306086 0
National Health and Medical Research Council (NHMRC)
Country [1] 306086 0
Australia
Primary sponsor type
University
Name
The University of Western Australia
Address
35 Stirling Highway, Nedlands, WA 6009
Country
Australia
Secondary sponsor category [1] 306555 0
None
Name [1] 306555 0
Address [1] 306555 0
Country [1] 306555 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 306306 0
Sir Charles Gairdner and Obsorne Park Health Care Group Human Research Ethics Committee
Ethics committee address [1] 306306 0
Ethics committee country [1] 306306 0
Australia
Date submitted for ethics approval [1] 306306 0
25/02/2020
Approval date [1] 306306 0
01/07/2020
Ethics approval number [1] 306306 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 103442 0
Prof Barry Marshall
Address 103442 0
The Marshall Centre
School of Biomedical Sciences,
The University of Western Australia
35 Stirling Highway
Perth WA 6009
Country 103442 0
Australia
Phone 103442 0
+61 8 6457 4817
Fax 103442 0
+61 8 6457 4816
Email 103442 0
[email protected]
Contact person for public queries
Name 103443 0
Mary Webberley
Address 103443 0
The Marshall Centre
School of Biomedical Sciences,
The University of Western Australia
35 Stirling Highway
Perth WA 6009
Country 103443 0
Australia
Phone 103443 0
+61 8 6457 2516
Fax 103443 0
+61 8 6457 4816
Email 103443 0
[email protected]
Contact person for scientific queries
Name 103444 0
Mary Webberley
Address 103444 0
The Marshall Centre
School of Biomedical Sciences,
The University of Western Australia
35 Stirling Highway
Perth WA 6009
Country 103444 0
Australia
Phone 103444 0
+61 8 6457 2516
Fax 103444 0
+61 8 6457 4815
Email 103444 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Data from the overall study population will be prepared by the Study Investigators and made available within the clinical study report provided to participating sites, and scientific publications in peer-review journals.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
8368OtherStudy Design Diagram for the Primary Outcome    Study Design Diagram for the Primary Outcome 380096-(Uploaded-30-06-2020-15-04-57)-Study-related document.docx



Results publications and other study-related documents

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