ANZCTR - Registration

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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

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]

Nil

Universal Trial Number (UTN)

Trial acronym

5URE

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Symptomatic pouch

Condition category

Condition code

Oral and Gastrointestinal

Inflammatory bowel disease

Inflammatory and Immune System

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]

Treatment: Other

Comparator / control treatment

No control group

Control group

Uncontrolled

Outcomes

Primary outcome [1]

Tolerability, assessed using 100mm VAS

Timepoint [1]

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]

Acceptability of the diet, assessed using the Diet Satisfaction Questionnaire

Timepoint [1]

Acceptability will be assessed once at the end of week 5( completion of the intervention)

Secondary outcome [2]

Clinical symptoms assessed using the clinical PDAI subscore

Timepoint [2]

Baseline and End of week 5( completion of the intervention)

Secondary outcome [3]

Bowel habits entered into the food diary

Timepoint [3]

Daily throughout the five weeks

Secondary outcome [4]

Obstructed defecation using the obstructed defecation scoring system, (ODSS)

Timepoint [4]

Baseline and end of week 5( completion of the intervention)

Secondary outcome [5]

Health-related quality of life using the Cleveland Global Quality of life

Timepoint [5]

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?

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

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

VIC

Recruitment hospital [1]

The Alfred - Melbourne

Recruitment postcode(s) [1]

3004 - Melbourne

Funding & Sponsors

Funding source category [1]

Other

Name [1]

Crohn's Colitis Australia

Address [1]

4/363 Camberwell Rd, Camberwell VIC 3124

Country [1]

Australia

Primary sponsor type

Hospital

Name

The Alfred

Address

55 Commercial Rd, Melbourne VIC 3004

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Alfred Ethics Committee

Ethics committee address [1]

55 Commercial Rd, Melbourne VIC 3004

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

21/11/2019

Approval date [1]

18/12/2019

Ethics approval number [1]

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

Prof Peter Gibson

Address

Alfred Health and Monash university
99 commercial road Melbourne 3004
Victoria, Australia

Country

Australia

Phone

+613 90762223

Fax

p.gibson@monash.edu

Contact person for public queries

Name

Zaid Ardalan

Address

Alfred Health and Monash university
99 commercial road Melbourne 3004
Victoria, Australia

Country

Australia

Phone

+61 409730301

Fax

zaid.ardalan@monash.edu

Contact person for scientific queries

Name

Zaid Ardalan

Address

Alfred Health and Monash university
99 commercial road Melbourne 3004
Victoria, Australia

Country

Australia

Phone

+61 409730301

Fax

zaid.ardalan@monash.edu

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 z.ardalan@alfred.org.au

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

Source	Title	Year of Publication	DOI
Embase	A novel Monash Pouch diet in patients with an ileoanal pouch is tolerable and has favorable metabolic luminal effects.	2023	https://dx.doi.org/10.1002/jgh3.13008

N.B. These documents automatically identified may not have been verified by the study sponsor.

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Documents added manually

Documents added automatically