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Trial registered on ANZCTR


Registration number
ACTRN12621000548831
Ethics application status
Approved
Date submitted
2/02/2021
Date registered
11/05/2021
Date last updated
12/04/2022
Date data sharing statement initially provided
11/05/2021
Type of registration
Retrospectively registered

Titles & IDs
Public title
The CKD Bowel Health Study
Scientific title
A mixed-method observational study of understanding the bowel health and gastrointestinal symptom management strategies in patients with chronic kidney disease (CKD)
Secondary ID [1] 302969 0
Nil Known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic Kidney Disease 320563 0
Gastro-Intestinal Intolerance 320564 0
Gut microbiome 321197 0
Condition category
Condition code
Renal and Urogenital 318417 318417 0 0
Kidney disease
Oral and Gastrointestinal 318418 318418 0 0
Inflammatory bowel disease

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
In patients with chronic kidney disease, we will observe the prevalence and risk factors of gastrointestinal intolerance before and after kidney transplantation. The duration of the observation will be anytime before transplantation, then 4, 12, and 28 weeks post-transplantation. Adults aged 18 years and older. Patients with kidney failure (CKD Stage 4 to 5D: estimated Glomerular Filtration Rate = 0 to 29 mL/min/1.73m2 and albuminuria > 300 mg/g) on dialysis listed on the deceased donor kidney transplant waiting list, or patients with kidney failure with a planned pre-emptive transplant within 12 months. This includes both kidney-only and simultaneous pancreas-kidney transplant candidates.


Three sub-studies will be undertaken as follows:

Study 1. An observational longitudinal study of the burden and risk factors of GI intolerance in kidney transplant candidates (patients with kidney failure on dialysis and are eligible for transplantation) and in kidney transplant recipients.
General patient contact information, demographic characteristics, medical history, and CKD health status will be collected via the Demographics Questionnaire.
The baseline assessments, pre-transplant of observational data will be collected via the Observational Questionnaire (Baseline): which will collect transplant status, current medications and supplements, general health via the EQ-5D Questionnaire, faecal characteristics using the Bristol Stool Chart, gastrointestinal symptoms via the Gastrointestinal Symptom Rating Scale (GSRS), quality of life using the Gastrointestinal Quality of Life Scale (GIQLS), personal management strategies of gut health and GI symptoms, dietary patterns using the Food Frequency Questionnaire (FFQ), and safety parameters and adverse events.
To repeat the instruments, the Observational Questionnaire (Follow-Up) will be repeated as the same form and administered at 4, 12, and 28 weeks post-transplant (28 weeks being the final follow-up time-points). This questionnaire contains the same instruments without the patient contact information and demographic sections. It will be administered by the study researcher face-to-face in clinic at usual visits, or completed by the patient at home where language and literacy skills are competent. The Observational Questionnaire takes approximately 30-60 minutes to complete.



Study 2. A semi-structured qualitative interview study in kidney transplant candidates and kidney transplant recipients. (A subset of the first 20 participants to agree will be selected from the Observational Study 1).
A semi-structured face-to-face interview will be conducted with each participant in their choice of either in a clinic room or via video conference. The interviews will be administered by the study research personnel who are research academics with training in qualitative research. Some participants may be known to the interviewers but only from the recruitment process. Neither interviewer will have clinically treated the participants.
The Qualitative Interview Guide includes the following sections:
Demographics
Interview 1: general perspectives and experience of gut health in CKD; perceived causes, impact and management of GI symptoms in CKD; expectations of transplantation; reasons for participating in the study;
Interview 2: experience of being in the study; experience of the transplant; experience of GI symptoms post-transplant
The guide was developed following a review of the literature and discussion among the research team consisting of nephrologists and public health (qualitative) academics. Schedule: Participants will be interviewed twice: once at baseline (anytime pre-transplant) (Visit 1) and once post-transplant at the 28-week follow-up (Visit 4). These will be approximately 30-45 minutes long.





Study 3. A discrete choice experiment of patient preferences regarding the perspectives of the different treatment and intervention strategies for the management of GI symptoms in patients with kidney transplants. All participants from study 1 will be approached to participate. (Options will be based on the outcomes of Study 2. Participant will be selected from the Observational Study 1, but also new recruits of kidney transplant recipients). At either Visit 3 or Visit 4, or anytime within 4 months post-transplant, participants will be administered the electronic Discrete Choice Experiment Survey (NGENE Software) directly after attending their usual medical appointment with their surgeon using a clinic computer. Participants will be identified by their name and participant study ID which will be linked to their baseline information. Demographics will have already been taken in Study 1. The survey will be administered as follows: (1) instructions and introduction of the study aim, (2) explanation of attributes, (3) explanation of choice sets.
In the Discrete Choice Experiment Survey, participants will be given 5 to 10 choice sets to answer their most preferred scenario of post-transplant treatment options. The anticipated survey time is approximately 5-10 minutes.
The attributes are: mode of taking supplements; average cost per month; access to supplements; dietary changes; post-transplant prescribed immunosuppressive medications.
The survey was developed following a review of the literature and discussion among the research team consisting of nephrologists and public health (qualitative) academics.
Intervention code [1] 319635 0
Not applicable
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 326397 0
Composite outcome: Prevalence of gastrointestinal intolerance (any severity) in patients with kidney disease before and after transplantation, collected via the Observational Questionnaire (Baseline): which will collect transplant status, current medications and supplements, faecal characteristics using the Bristol Stool Chart, gastrointestinal symptoms via the Gastrointestinal Symptom Rating Scale (GSRS), quality of life using the Gastrointestinal Quality of Life Scale (GIQLS), personal management strategies of gut health and GI symptoms, dietary patterns using the Food Frequency Questionnaire (FFQ), and safety parameters and adverse events.
Timepoint [1] 326397 0
1. Observational Questionnaire (Baseline) (anytime before kidney transplant)
2. Observational Questionnaire (Follow-up) at 4 weeks post kidney transplant
3. Observational Questionnaire (Follow-up) at 12 weeks post kidney transplant
4. Observational Questionnaire (Follow-up) at 28 weeks post kidney transplant
Primary outcome [2] 326398 0
Composite outcome: Change in gastrointestinal intolerance (any severity) symptom burden before and after transplantation, collected via the Observational Questionnaire (Baseline): which will collect transplant status, current medications and supplements, faecal characteristics using the Bristol Stool Chart, gastrointestinal symptoms via the Gastrointestinal Symptom Rating Scale (GSRS), quality of life using the Gastrointestinal Quality of Life Scale (GIQLS), personal management strategies of gut health and GI symptoms, dietary patterns using the Food Frequency Questionnaire (FFQ), and safety parameters and adverse events. Before and after will be assessed by comparing the questionnaires performed at baseline, 4, 12, 28 weeks post-transplant.
Timepoint [2] 326398 0
1. Observational Questionnaire (Baseline) (anytime before kidney transplant)
2. Observational Questionnaire (Follow-up) at 4 weeks post kidney transplant
3. Observational Questionnaire (Follow-up) at 12 weeks post kidney transplant
4. Observational Questionnaire (Follow-up) at 28 weeks post kidney transplant
Primary outcome [3] 326399 0
Safety parameters and adverse events. Collected as open fields to provide the opportunity to report anything undue by the patient during this process.
Timepoint [3] 326399 0
1. Observational Questionnaire (Baseline) (anytime before kidney transplant)
2. Observational Questionnaire (Follow-up) at 4 weeks post kidney transplant
3. Observational Questionnaire (Follow-up) at 12 weeks post kidney transplant
4. Observational Questionnaire (Follow-up) at 28 weeks post kidney transplant
Secondary outcome [1] 391322 0
Stool characteristics (Bristol Stool Chart - 7 point scale of stool varieties from constipated to diarrhoea)
Timepoint [1] 391322 0
1. Anytime before kidney transplant
2. Follow-up at 4 weeks post kidney transplant
3. Follow-up at 12 weeks post kidney transplant
4. Follow-up at 28 weeks post kidney transplant
Secondary outcome [2] 391323 0
Understand patients’ perspectives and attitudes towards gut health, their own beliefs about how their gut health impacts their CKD condition, and their experiences with ways to improve or maintain gut health. (Instrument: A semi-structured face-to-face interview will be conducted with each participant in their choice of either in a clinic room or via video conference)
Timepoint [2] 391323 0
1. At baseline collection (anytime before kidney transplant)
2. At 28 weeks post kidney transplant follow-up collection
Secondary outcome [3] 393114 0
Post-transplant preferences of treatment strategies in patients with GI intolerance. (Instrument: Discrete Choice Experiment of five attributes: mode of taking supplements; average cost per month; access to supplements; dietary changes; post-transplant prescribed immunosuppressive medications.)
Timepoint [3] 393114 0
A once-off single DCE survey at anytime >4 weeks up to 28 weeks post-transplant.
Secondary outcome [4] 394955 0
General health and quality of life via the EQ-5D Questionnaire
Timepoint [4] 394955 0
1. Anytime before kidney transplant
2. Follow-up at 4 weeks post kidney transplant
3. Follow-up at 12 weeks post kidney transplant
4. Follow-up at 28 weeks post kidney transplant

Eligibility
Key inclusion criteria
Adults aged 18 years and older.
Patients with kidney failure (CKD Stage 4 to 5D: estimated Glomerular Filtration Rate between 0 to 29 mL/min/1.73m2 and albuminuria greater than 300 mg/g) on dialysis and/or listed on the deceased donor kidney transplant waiting list, or patients with kidney failure with a planned pre-emptive transplant within 12 months.
This includes both kidney-only and simultaneous pancreas-kidney transplant candidates.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Prior bowel resection.
Chronic pancreatic insufficiency history of inflammatory bowel disease.
Recent infection-related diarrhoea.
Unable to give informed consent.

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
Study 1
a. Descriptive analysis of the prevalence and management strategies of GI intolerance in patients with kidney failure and have a kidney transplant.
b. Baseline characteristics and dietary patterns will be compared between recipients with and without GI intolerance using chi-square (to compare categorical variables), analysis of variance (compare means for normally-distributed variables) and Kruskal-Wallis tests (to compare medians for non-normally-distributed variables).
c. Longitudinal mixed models with random intercepts will be conducted to assess the relationship between dietary patterns and GI intolerance, accounting for confounders including age, sex, medication use, and CKD stage.
d. Sample size: this is a longitudinal study of the effects of diet and/or medication use and/or management strategies on GI symptoms before and after kidney transplant. The sample size of 100 participants to complete the study has been determined as adequate to have the power to test the primary outcomes of prevalence of GI symptoms estimated at 11% in the CKD population (Hill, et al., 2016).

Study 2
a. Interviews will be recorded with the participant consent and transcribed verbatim. Transcript will be analysed using HyperRESEARCH V.3.7.3 software (Researchware, Inc., 2020). Field notes will also be taken.
b. Thematic analysis will be used to independently code all transcripts and notes line by line by two study personnel to identify concepts. Following the thematic analysis (of two interviews per participant) we will convene a discussion group with all patients who had participated to discuss the preliminary themes and findings to ascertain whether they appropriately reflect the perspectives of the CKD patients. This will be via Zoom and for practical technology purposes we will split into two groups of 15.

Study 3
a. We will use “NLOGIT, version 5.0 (Econometric Software, Castle Hill, NSW, Australia; www.limdep.com/products/ nlogit/) to analyse the data. Internal validity (that is, the extent to which results were consistent with the researchers’ prior expectations) will be assessed by examining the signs and significance of parameter estimates."
b. Sample size: for the Discrete Choice Experiment Survey we used the electronic software NGENE (NGENE Software, 2020) to ascertain the required sample size of 62 participants to
account for 5 randomisation blocks of 5 attributes.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
1/04/2021
Date of last participant enrolment
Anticipated
30/11/2022
Actual
Date of last data collection
Anticipated
28/02/2023
Actual
Sample size
Target
170
Accrual to date
140
Final
Recruitment in Australia
Recruitment state(s)
NSW,WA
Recruitment hospital [1] 18562 0
Westmead Hospital - Westmead
Recruitment hospital [2] 18563 0
Sir Charles Gairdner Hospital - Nedlands
Recruitment postcode(s) [1] 32933 0
2145 - Westmead
Recruitment postcode(s) [2] 32934 0
6009 - Nedlands
Recruitment postcode(s) [3] 32935 0
2145 - Wentworthville
Recruitment postcode(s) [4] 32936 0
6009 - Broadway Nedlands

Funding & Sponsors
Funding source category [1] 307388 0
Government body
Name [1] 307388 0
NHMRC
Country [1] 307388 0
Australia
Primary sponsor type
Individual
Name
Prof Germaine Wong
Address
Renal Ward
Westmead Hospital
Hawkesbury Rd, Westmead NSW 2145
Country
Australia
Secondary sponsor category [1] 308948 0
None
Name [1] 308948 0
Address [1] 308948 0
Country [1] 308948 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 307474 0
Western Sydney Local Health District
Ethics committee address [1] 307474 0
Ethics committee country [1] 307474 0
Australia
Date submitted for ethics approval [1] 307474 0
10/11/2020
Approval date [1] 307474 0
18/01/2021
Ethics approval number [1] 307474 0
2020/ETH03007

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

Contacts
Principal investigator
Name 107358 0
Prof Germaine Wong
Address 107358 0
Renal Transplant Unit
Westmead Hospital
Hawkesbury Road, Westmead NSW 2145
Country 107358 0
Australia
Phone 107358 0
+61 411603282
Fax 107358 0
Email 107358 0
[email protected]
Contact person for public queries
Name 107359 0
Tess Cooper
Address 107359 0
Centre for Kidney Research
Children's Hospital at Westmead
Hawkesbury Road, Westmead NSW 2145
Country 107359 0
Australia
Phone 107359 0
+61 426483629
Fax 107359 0
Email 107359 0
[email protected]
Contact person for scientific queries
Name 107360 0
Tess Cooper
Address 107360 0
Centre for Kidney Research
Children's Hospital at Westmead
Hawkesbury Road, Westmead NSW 2145
Country 107360 0
Australia
Phone 107360 0
+61 426483629
Fax 107360 0
Email 107360 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
No consent for IPD data to be made available for sharing will be sought from the participants.


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseThe CKD bowel health study: understanding the bowel health and gastrointestinal symptom management in patients with chronic kidney disease: a mixed-methods observational longitudinal study (protocol).2021https://dx.doi.org/10.1186/s12882-021-02600-x
EmbasePatient Preferences for the Management of Gastrointestinal Symptoms in Kidney Transplantation: a Discrete Choice Experiment.2023https://dx.doi.org/10.1016/j.ekir.2023.07.034
N.B. These documents automatically identified may not have been verified by the study sponsor.