Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621000374864
Ethics application status
Approved
Date submitted
15/10/2020
Date registered
1/04/2021
Date last updated
1/04/2021
Date data sharing statement initially provided
1/04/2021
Date results information initially provided
1/04/2021
Type of registration
Retrospectively registered

Titles & IDs
Public title
A preliminary study of a sulfide-reducing diet in patients with an ileoanal pouch
Scientific title
A pilot study of the 5URE diet in patients with an ileal pouch anal anastomosis (IPAA)
Secondary ID [1] 301206 0
Nil
Universal Trial Number (UTN)
Trial acronym
5URE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Symptomatic pouch 317351 0
Condition category
Condition code
Oral and Gastrointestinal 315458 315458 0 0
Inflammatory bowel disease
Inflammatory and Immune System 317863 317863 0 0
Other inflammatory or immune system disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A 5-week dietary intervention targeting pouch sulfide production (5URE diet) will be administered to 12 participants with pouch-related symptoms. Participants will undergo one 1-hour face-to-face education on the 5URE diet with a study dietitian and be provided with an adaptation meal plan to follow in the first week along with a diet guide and a recipe book specifically designed for the study. The research dietitian delivering the intervention will have ~10 years experience and was responsible for designing the 5URE diet. Patients' compliance and adherence will be followed with weekly phone calls by the study researchers who will go over a checklist designed for the diet.

Prior to starting the 5-week dietary intervention, the participants will complete a one-week food diary(baseline diary). Additionally on the last day before their second visit they will be asked to collect their stool over 24 hours in takeaway containers that are immediately placed in portable freezers provided to the patients.
Intervention code [1] 317506 0
Treatment: Other
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 325388 0
Tolerability, assessed using 100mm VAS
Timepoint [1] 325388 0
Tolerability will be assessed weekly for 5 weeks. At the end of each week, participants will enter their tolerability of the diet in the study diary using a 100-mm visual analogue scale (VAS) where 0 = “extremely difficult to tolerate” and 100 = “extremely easy to tolerate.
Secondary outcome [1] 387732 0
Acceptability of the diet, assessed using the Diet Satisfaction Questionnaire
Timepoint [1] 387732 0
Acceptability will be assessed once at the end of week 5( completion of the intervention)
Secondary outcome [2] 387733 0
Clinical symptoms assessed using the clinical PDAI subscore
Timepoint [2] 387733 0
Baseline and End of week 5( completion of the intervention)
Secondary outcome [3] 389406 0
Bowel habits entered into the food diary
Timepoint [3] 389406 0
Daily throughout the five weeks
Secondary outcome [4] 389407 0
Obstructed defecation using the obstructed defecation scoring system, (ODSS)
Timepoint [4] 389407 0
Baseline and end of week 5( completion of the intervention)
Secondary outcome [5] 392593 0
Health-related quality of life using the Cleveland Global Quality of life
Timepoint [5] 392593 0
Baseline and end of week 5

Eligibility
Key inclusion criteria
• Patients with ileoanal pouch
• Patient able to give informed consent
• Age > 18 years
• Eligible for Medicare
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• Inability to provide informed consent
• Coeliac disease
• Recent use, in the last month of
.1 Oral or intravenous antibiotics (including sulfasalazine)
.2 Pro- or prebiotic agents
.3 Fibre supplements
.4 Amino salicylates
.5 Corticosteroids
.6 Immunosuppressive agents as azathioprine, 6-mercaptopurines or methotrexate.
.7 Biologic agents as infliximab, adalimumab, ustekinumab, vedolizumab
• Individuals following a predominantly plant-based or vegan diet
• Pregnant patients or or trying to become pregnant, or breast-feeding.

Study design
Purpose of the study
Treatment
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
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
Data were stored on an Excel spreadsheet [Microsoft] and analysed on SPSS v26 statistical analysis software [IBM]. Distributions of all continuous variables were assessed for normality using the Shapiro-Wilk test. Continuous variables are presented as mean ± SD as well as median [interquartile range, IQR]. Nominal variables such as sex and pouch phenotype are summarized in frequency tables and are presented as n [%]. Normally distributed continuous variables were compared using the two-sample paired-t test and abnormally distributed continuous variables were compared using the Wilcoxon-signed rank test or sign test if differences were not symmetrically distributed. Nominal variables were compared using the McNamara test. In the post-hoc analysis, Mann-Whitney U test was used to determine if there was any difference in median tolerability VAS between patients with recent pouchitis and those without, and between symptomatic and asymptomatic patients. Fisher’s Exact test was used to determine the difference in proportion of patients with excellent tolerability between patients with recent pouchitis and those without, and between symptomatic and asymptomatic patients. Friedman test was used to see if there was a statistically significant change in tolerability VAS over the course of the study. A False Discovery Rate (FDR) was applied to multiple comparisons to control for Type 1 error. All tests are two-sided and considered significant at p = 0.05.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
19/02/2020
Date of last participant enrolment
Anticipated
Actual
25/03/2020
Date of last data collection
Anticipated
Actual
16/09/2020
Sample size
Target
12
Accrual to date
Final
12
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 17820 0
The Alfred - Melbourne
Recruitment postcode(s) [1] 31673 0
3004 - Melbourne

Funding & Sponsors
Funding source category [1] 305655 0
Other
Name [1] 305655 0
Crohn's Colitis Australia
Country [1] 305655 0
Australia
Primary sponsor type
Hospital
Name
The Alfred
Address
55 Commercial Rd, Melbourne VIC 3004
Country
Australia
Secondary sponsor category [1] 307537 0
None
Name [1] 307537 0
Address [1] 307537 0
Country [1] 307537 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 305938 0
Alfred Ethics Committee
Ethics committee address [1] 305938 0
55 Commercial Rd, Melbourne VIC 3004
Ethics committee country [1] 305938 0
Australia
Date submitted for ethics approval [1] 305938 0
21/11/2019
Approval date [1] 305938 0
18/12/2019
Ethics approval number [1] 305938 0
58716

Summary
Brief summary
Resection of the large bowel and creation of a new rectum or reservoir by forming a pouch from the small bowel is the surgical treatment of choice for ulcerative colitis (UC) and familial adenomatous polyposis (FAP). The new reservoir is termed ileal pouch anal anastomosis (IPAA) or ileoanal pouch. Quality of life following IPAA creation is generally good. However, a considerable number of patients have persistent pouch-related symptoms of increased frequency, urgency, leakage and incontinence. Furthermore, most patients report food intolerances and the need to alter their diet to mitigate or improve symptoms. Additionally, around 40-50% of UC IPAA and 10-20% of FAP IPAA develop inflammation of the pouch, called pouchitis.

Increased exposure of the pouch mucosa to hydrogen sulphide (H2S), reduced exposure to SCFA, particularly butyrate, and excessive delivery of water to the pouch are putatively pathogenic factors in pouch dysfunction. We hypothesised that dietary change that reverses these might lead to improved pouch function and less inflammation and have designed a dietary approach that manipulates carbohydrate and protein fermentation such that H2S production can be minimised and SCFA deficiency can be corrected, the free water content of ileal effluent can be reduced, and substrates that contain sulphur minimised so that reductive pathways to H2S production can be suppressed. An innovative whole food diet strategy called a ‘5-strategies to a SUlphide-REducing’ (5URE) diet was developed.The study would include a baseline period of 1 week whereby a patient’s usual diet is assessed through a food diary. A dietitian educates participants on the components of the SURE diet, which patients then follow for 5 weeks. During this time, they will complete food diaries and receive a phone call three weeks after starting the diet to inquire about adherence and to help answer any questions. Participants are encouraged to contact the research for any query.
The total study will include three visits. Questionnaires are be used to assess how the subject is tolerating and accepting the diet, and to document the effects on bowel symptoms and health-related quality of life. Participants are asked to collect a small sample of stool on the day before they start the diet (reflecting their usual diet), and the last day of the SURE diet (to assess the effects of the diet). The results will inform further adjustments to the dietary approach and form the basis from future clinical trials.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 102138 0
Prof Peter Gibson
Address 102138 0
Alfred Health and Monash university
99 commercial road Melbourne 3004
Victoria, Australia
Country 102138 0
Australia
Phone 102138 0
+613 90762223
Fax 102138 0
Email 102138 0
[email protected]
Contact person for public queries
Name 102139 0
Dr Zaid Ardalan
Address 102139 0
Alfred Health and Monash university
99 commercial road Melbourne 3004
Victoria, Australia
Country 102139 0
Australia
Phone 102139 0
+61 409730301
Fax 102139 0
Email 102139 0
[email protected]
Contact person for scientific queries
Name 102140 0
Dr Zaid Ardalan
Address 102140 0
Alfred Health and Monash university
99 commercial road Melbourne 3004
Victoria, Australia
Country 102140 0
Australia
Phone 102140 0
+61 409730301
Fax 102140 0
Email 102140 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Data will be published. Of course, IPD will be included in the published article in the manuscript, tables, figures or as supplemental materials. Examples of individual data collected and will be shared include demographic, age and type of ileoanal pouch, indication for ileoanal pouch, current and previous medications, pouch phenotype.
When will data be available (start and end dates)?
At the end of the study and following publication.
No end date available.
Available to whom?
Furthermore, on a case by case bases, researchers who approach the authors/investigators asking for more data may be provided with such data.
Available for what types of analyses?
Depends on the research question. The raw data includes categorical and contagious variables that could be analysed in numerous ways depending on the statistical question.
How or where can data be obtained?
By contacting Dr.Zaid Ardalan [email protected]


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
EmbaseA novel Monash Pouch diet in patients with an ileoanal pouch is tolerable and has favorable metabolic luminal effects.2023https://dx.doi.org/10.1002/jgh3.13008
N.B. These documents automatically identified may not have been verified by the study sponsor.