Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624000912583
Ethics application status
Approved
Date submitted
9/07/2024
Date registered
26/07/2024
Date last updated
26/07/2024
Date data sharing statement initially provided
26/07/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Fermentation characteristics of individuals with patients with an ileoanal pouch compared to ulcerative colitis and a healthy colon
Scientific title
Microbial fermentative capacity of individuals with ulcerative colitis with an ileoanal pouch compared to a healthy or ulcerative colitis with intact colons: an in vitro study
Secondary ID [1] 312415 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Inflammatory bowel disease 334228 0
Ileoanal pouch 334229 0
Pouchitis 334230 0
J pouch 334231 0
Ulcerative colitis 334232 0
Condition category
Condition code
Oral and Gastrointestinal 330897 330897 0 0
Inflammatory bowel disease
Surgery 330898 330898 0 0
Other surgery
Inflammatory and Immune System 331069 331069 0 0
Other inflammatory or immune system disorders

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
This will be a cross-sectional study involving a single fresh faecal sample collection on one occasion,

The in vitro study will consist of a single screening phone call and a single faecal collection that takes place before 12pm on the study day.
Pre-study day:

Patients will be asked to refrain from eating foods high in oligosaccharides (i.e. garlic/onion), resistant starch (i.e. under-ripe banana, legumes) for 24 h. This is to minimise any residual fibres in the collected stool from impacting on their fermentation profiles. Additionally, participants who are taking loperamide will be asked to cease loperamide for 24 h to aid with the ease of stool collection. They can resume loperamide use following faecal collection. Additionally, subjects will be asked to record their food and fluid intake for a 24-h period prior to collection of a stool sample. A 24hr food diary will be provided to participants to complete, This will provide a snapshot of participant's dietary intake and whether this has any influence on the activity of faecal bacteria or gas production. Recording food and fluid intake in the food record may take up to 15 minutes.

Study collection day:

Participants will be given the option of collecting a freshly passed faecal sample at home or attend a study visit at the Department of Gastroenterology, Alfred Centre to have a fresh faecal sample collected during their visit. This will be communicated to them at the time of the screening phone call.

Faecal collection at home:
Prior to the collection day, participants will be given instructions on collecting faecal samples and contacting the researcher within 0.5 h of collection. Samples are used within ~1.5 hours of passage to ensure that microbiota are viable. They will be posted a faecal collection kit containing toilet liners, instructions, gloves, a biohazard safety bag and a container with an anaerobic strip for collection in the mail. They will also be provided with a padded envelope and box to place the biohazard bag into for transport. As soon as a faecal sample has been passed, participants will contact the researcher immediately who will then organise for the faecal sample to be collected via courier and transported to Monash Clayton for processing.

Faecal collection at the Alfred Centre or at Monash University:
Patients will have the option to attend for a study visit at either School of Translational Medicine, Monash University located at The Alfred Centre or Biomedicine Discovery Institute (ground floor) Monash University, Clayton for sample collection. Patients will be met by the study coordinator at The Alfred Centre (ground floor) or Monash Biomedicine Discovery Institute (ground floor) and be provided with the faecal collection kit and a $ 10 food and drink voucher so they can purchase food and drink whilst waiting for the faecal collection. Once the patient feels the urge to use their bowels or empty their pouch, they will be asked to use the available toilets for sample collection. Patients at will be shown by a member of the research team appropriate toilets to use. Those at Monash Clayton at will be shown to the toilets at ground floor of the Monash Biomedicine Discovery Research Institute and those at the School of Translational Medicine will be shown to level 6 toilets. Once safely collected, these will be provided back to the study coordinator for immediate sample processing.

Protocol:
During the visit, a single freshly passed faecal sample will be collected into a sealed plastic takeaway container containing an anaerobic strip. Gloves and instructions will be provided to participants either on the day of stool collection if they attend a visit, or it will be posted to them if they collect the sample at home.

It is expected that the actual sample collection will take no longer than 15 minutes, however, the amount of time spent at The Alfred will depend on the frequency of bowel motions experienced by patients. Patients will be asked to ideally attend for a study visit at the usual bowel/pouch emptying times, to avoid unnecessary waiting.
Intervention code [1] 328998 0
Not applicable
Comparator / control treatment
No control as this is not an interventional study. However, we will be comparing patients with an intact colon (healthy and ulcerative colitis) compared to patients with an ileoanal pouch. Patients with an intact colon will undergo the same study procedures as patients with an ileoanal pouch.
Control group
Active

Outcomes
Primary outcome [1] 338753 0
Total gas production in 4hrs
Timepoint [1] 338753 0
Cross-sectional assessed only once over a 4 hour period on the day of study visit
Secondary outcome [1] 437339 0
Change in SCFA will be assessed only once immediately after samples have been taken.
Timepoint [1] 437339 0
Cross-sectional assessed once only at time of study visit
Secondary outcome [2] 437340 0
Changes in pH
Timepoint [2] 437340 0
Cross-sectional assessed once only at time of study visit

Eligibility
Key inclusion criteria
Three cohorts of subjects will be recruited:
(1) Patients with UC-pouches
Patients with both current active pouchitis (n=10) and without pouchitis (n=10) will be recruited via social media, advertisements, word of mouth and the Alfred inflammatory bowel disease (IBD) clinic. Active pouchitis will be defined as PDAI >7 and without pouchitis will be a pouch disease activity index (PDAI) <7 as determined by histologic, clinical and endoscopic assessment. If patients are recruited from the Alfred, pouchoscopies will be completed via standard of care for patients who are already coming into attend the pouch clinic.
(2) n=20 patients with UC with mild to moderately disease activity (n=10) and patients in clinical remission (n=10) will be recruited via the same channels as the first cohort. Diagnosis of activity or remission was determined based on faecal calprotectin and the Partial Mayo questionnaire. If available, these results can also be confirmed with intestinal ultrasound to confirm findings and colonoscopy and histology reports.
(3) A total of 10 healthy controls with an intact colon and no history of gastrointestinal diseases (i.e. coeliac disease, inflammatory bowel disease) and no active investigations for gastrointestinal issues will be recruited from study flyers or word of mouth.
Apart from the inclusion criteria above, the following applies to all groups:
Inclusion criteria:
- Living in Metropolitan Melbourne
- 18-75 years old
- Ability to speak and read English
- Eligible for Medicare
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Exclusion criteria:
- Presence of Crohn’s disease, coeliac disease and indeterminate colitis
- Prebiotic, probiotic supplements in the last 2 weeks
- Antibiotic use (including sulfasalazine) in last 4 weeks except if they have pouchitis that is antibiotic-dependent.
- Unable to provide informed consent

Study design
Purpose
Natural history
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
30/07/2024
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
50
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 26770 0
The Alfred - Melbourne
Recruitment postcode(s) [1] 42821 0
3004 - Melbourne

Funding & Sponsors
Funding source category [1] 316828 0
University
Name [1] 316828 0
Monash University
Country [1] 316828 0
Australia
Primary sponsor type
University
Name
Monash University
Address
Country
Australia
Secondary sponsor category [1] 319056 0
None
Name [1] 319056 0
Address [1] 319056 0
Country [1] 319056 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 315596 0
Alfred Hospital Ethics Committee
Ethics committee address [1] 315596 0
Ethics committee country [1] 315596 0
Australia
Date submitted for ethics approval [1] 315596 0
30/05/2024
Approval date [1] 315596 0
07/06/2024
Ethics approval number [1] 315596 0

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

Contacts
Principal investigator
Name 135190 0
Dr Chu Kion Yao
Address 135190 0
Monash University Department of Gastroenterology Level 6 99 Commercial Rd Melbourne VIC 3004
Country 135190 0
Australia
Phone 135190 0
+613 9903 0266
Fax 135190 0
Email 135190 0
[email protected]
Contact person for public queries
Name 135191 0
Dakota Rhys-Jones
Address 135191 0
Monash University Department of Gastroenterology Level 6 99 Commercial Rd Melbourne VIC 3004
Country 135191 0
Australia
Phone 135191 0
+613 99030367
Fax 135191 0
Email 135191 0
[email protected]
Contact person for scientific queries
Name 135192 0
Chu Kion Yao
Address 135192 0
Monash University Department of Gastroenterology Level 6 99 Commercial Rd Melbourne VIC 3004
Country 135192 0
Australia
Phone 135192 0
+613 99030266
Fax 135192 0
Email 135192 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


What supporting documents are/will be available?




Results publications and other study-related documents

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

Documents added automatically
No additional documents have been identified.