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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03078634




Registration number
NCT03078634
Ethics application status
Date submitted
24/02/2017
Date registered
13/03/2017

Titles & IDs
Public title
The Multi-disciplinary Treatment of Functional Gut Disorders Study
Scientific title
The MANTRA Study: The Multi-disciplinary Treatment of Functional Gut Disorders Study
Secondary ID [1] 0 0
MANTRA
Universal Trial Number (UTN)
Trial acronym
MANTRA
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Irritable Bowel Syndrome 0 0
Functional Dyspepsia 0 0
Constipation - Functional 0 0
Faecal Incontinence 0 0
Functional Abdominal Pain Syndrome 0 0
Other Rome IV Functional Gastrointestinal Disorders 0 0
Condition category
Condition code
Oral and Gastrointestinal 0 0 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Other 0 0 0 0
Research that is not of generic health relevance and not applicable to specific health categories listed above

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other interventions - Multi-disciplinary clinic model
Other interventions - Standard outpatient care

Active comparator: Multi-Disciplinary clinic -

Placebo comparator: Standard Gastrointestinal clinic -


Other interventions: Multi-disciplinary clinic model
Clinic model incorporating multiple disciplines for the treatment of functional gut disorders. Disciplines include: gastroenterologists, psychiatrists, psychologists, hypnotherapists, behavioural therapists and dieticians. End of clinic case conference involving clinical disciplines will also occur to coordinate care.

Other interventions: Standard outpatient care
Standard care provided in outpatient clinics staffed by GI doctors only
Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Proportion of subjects with global improvement in their condition.
Timepoint [1] 0 0
Definition of discharge timepoint: Day 1 of being discharged from clinic, or 9 months after baseline visit, whichever occurs first.
Secondary outcome [1] 0 0
Proportion of subjects, with Irritable bowel syndrome or centrally mediated abdominal pain syndrome, with a 50% reduction in Irritable bowel syndrome severity scoring system (IBS-SSS)
Timepoint [1] 0 0
A) Day 1 of being discharged from clinic, or 9 months after baseline visit, whichever occurs first. B) 12 months after discharge.
Secondary outcome [2] 0 0
Proportion of subjects with constipation who score a 50% reduction in Cleveland clinic constipation scoring system
Timepoint [2] 0 0
A) Day 1 of being discharged from clinic, or 9 months after baseline visit, whichever occurs first. B) 12 months after discharge.
Secondary outcome [3] 0 0
Proportion of subjects with faecal incontinence who score a 50% reduction in St Mark's Incontinence score
Timepoint [3] 0 0
A) Day 1 of being discharged from clinic, or 9 months after baseline visit, whichever occurs first. B) 12 months after discharge.
Secondary outcome [4] 0 0
Proportion of subjects with functional dyspepsia who score a 50% reduction in the symptom score of the Nepean dyspepsia index
Timepoint [4] 0 0
A) Day 1 of being discharged from clinic, or 9 months after baseline visit, whichever occurs first. B) 12 months after discharge.
Secondary outcome [5] 0 0
Quality of life as measured by RAND SF-36 v1
Timepoint [5] 0 0
A) Day 1 of being discharged from clinic, or 9 months after baseline visit, whichever occurs first. B) 12 months after discharge.
Secondary outcome [6] 0 0
Quality of life as measured by Euro-QOL EQ-5D
Timepoint [6] 0 0
A) Day 1 of being discharged from clinic, or 9 months after baseline visit, whichever occurs first. B) 12 months after discharge.
Secondary outcome [7] 0 0
Psychological wellbeing as measured by hospital anxiety and depression score (HADS)
Timepoint [7] 0 0
A) Day 1 of being discharged from clinic, or 9 months after baseline visit, whichever occurs first. B)12 months after discharge.
Secondary outcome [8] 0 0
Proportion of subjects with who answer yes to: In the past 7 days, have you had adequate relief of your gut condition? [YES/NO]
Timepoint [8] 0 0
A) Day 1 of being discharged from clinic, or 9 months after baseline visit, whichever occurs first. B) 12 months after discharge.
Secondary outcome [9] 0 0
Somatisation as measured by somatic symptom scale-8 (SSS-8)
Timepoint [9] 0 0
A) Day 1 of being discharged from clinic, or 9 months after baseline visit, whichever occurs first. B) 12 months after discharge.
Secondary outcome [10] 0 0
Cost to the healthcare system
Timepoint [10] 0 0
A) Day 1 of being discharged from clinic, or 9 months after baseline visit, whichever occurs first. B) 12 months after discharge.
Secondary outcome [11] 0 0
Proportion of subjects with global improvement in their condition.
Timepoint [11] 0 0
A) Day 1 of being discharged from clinic, or 9 months after baseline visit, whichever occurs first. B) 12 months after discharge.
Secondary outcome [12] 0 0
Proportion of subjects with a 50% reduction in gastrointestinal symptom severity index score
Timepoint [12] 0 0
A) Day 1 of being discharged from clinic, or 9 months after baseline visit, whichever occurs first. B) 12 months after discharge.

Eligibility
Key inclusion criteria
* Functional gastrointestinal disorder as defined by Rome IV
Minimum age
18 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
* Diagnosed or suspicion of organic gastrointestinal disorder (ie Coeliac, IBD)
* Age <18 or >80
* Non-English speaking
* Patient's from outside of metropolitan Melbourne who cannot attend clinic visits
* Prominent eating disorder
* Chronic opioid dependence
* Medications which can explain functional gut symptoms
* Surgery of GI tract that can explain functional gut symptoms
* Major, non-GI, organ dysfunction
* Pregnancy
* Major Psychiatric disorder

Study design
Purpose of the study
Other
Allocation to intervention
Randomised controlled 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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
NA
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
16/03/2017
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
28/04/2020
Sample size
Target
Accrual to date
Final
188
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
St Vincent's Hospital - Melbourne
Recruitment postcode(s) [1] 0 0
3065 - Melbourne

Funding & Sponsors
Primary sponsor type
Other
Name
St Vincent's Hospital Melbourne
Address
Country

Ethics approval
Ethics application status

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

Contacts
Principal investigator
Name 0 0
Chamara Basnayake, MBBS
Address 0 0
Gastroenterologist / PhD candidate
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT03078634