Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622000813785
Ethics application status
Approved
Date submitted
2/06/2022
Date registered
9/06/2022
Date last updated
9/06/2022
Date data sharing statement initially provided
9/06/2022
Type of registration
Retrospectively registered

Titles & IDs
Public title
A comparative study examining the in vitro fermentation by ileal microbiota obtained from human ileostomy subjects and an animal model
Scientific title
A comparative study examining the in vitro fermentation by ileal microbiota obtained from human ileostomy subjects and an animal model
Secondary ID [1] 307274 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Human ileostomy subjects 326531 0
Condition category
Condition code
Diet and Nutrition 323795 323795 0 0
Other diet and nutrition disorders
Oral and Gastrointestinal 323796 323796 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Six participants with normally functioning ileostomies (following a total colectomy) will be recruited. One week before the study day, the participants will be requested to consume the foods that are part of the test meal (see below) as part of their normal diet. They will be asked to keep a diary of how much of and when these ingredients are consumed. The evening before the study day, all participants will receive one pre-prepared meal containing all the foods that will comprise the test meal.
On the study day, participants will fast overnight (~14 hours). At 8:00 am, they will consume the test meal at home within 30 minutes (unsupervised). The test meal will consist of 100 g cooked rice, ½ boiled egg, 50 g baked beans, 25 g Weet-bix, 150 mL milk, a small apple, and 200 mL water. This meal will deliver about 20% of the daily energy requirement of an adult human (~430 kcal) and will contain 17 g protein (16% kcal), 15 g fat (31% kcal) and 53 g carbohydrate (50% kcal; of which 6.7 g will be dietary fibre). The same meal will be given to pigs so that we can compare the two species. Participants will consume 200 mL water at two hours post-meal and 200 mL energy drink (active component: glucose) at four hours post-meal. Two hours post-meal (10 am), the participants will attach a new ostomy bag. Effluent will be collected for four hours (until 2 pm), and the participants will replace the ostomy bag hourly. Overall duration of participation on the study day is 6 hours. The effluent will be collected by the researcher and used to prepare a microbial inoculum to ferment different purified fibre substrates using the in vitro fermentation assay developed at our institute.
Intervention code [1] 323712 0
Early detection / Screening
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 331566 0
In vitro fermentation of fibre substrates by ileal microbiota obtained from human ileostomy subjects, measured by disappearance of organic matter
Timepoint [1] 331566 0
After 2h of in vitro fermentation
Primary outcome [2] 331624 0
Production of organic acids during in vitro fermentation of fibre substrates by ileal microbiota obtained from human ileostomy subjects, measured using a gas chromatography methodology
Timepoint [2] 331624 0
After 2h of in vitro fermentation
Secondary outcome [1] 410314 0
Relative abundance of bacteria in ileal effluent determined via Illumina sequencing, based on the16S rRNA gene
Timepoint [1] 410314 0
After 4h of collection
Secondary outcome [2] 410566 0
Total number of 16S rRNA gene copies in ileal effluent, measured with a qPCR methodology
Timepoint [2] 410566 0
After 4h of collection

Eligibility
Key inclusion criteria
They must have a well-established and normally functioning ileostomy following a total colectomy for ulcerative colitis with <10 cm of the terminal ileum removed.
BMI between 18 and 27 kg/m2.
Minimum age
18 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
They will not:
• Smoke cigarettes or take recreational drugs
• Have kidney failure or diabetes
• Have taken antibiotics or other medication that might affect the small intestinal microbial population within the three months before participating in the study
• Have an alcohol intake >2 standard drinks per day
• Be pregnant or breastfeeding
• Be intolerant or allergic to dairy products, wheat (including gluten) or apple.
• Be on a controlled diet or dietary weight loss regime for three months before participating in the study or during the study

Study design
Purpose of the study
Diagnosis
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

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
29/04/2021
Date of last participant enrolment
Anticipated
Actual
28/09/2021
Date of last data collection
Anticipated
Actual
3/12/2021
Sample size
Target
6
Accrual to date
Final
5
Recruitment outside Australia
Country [1] 24814 0
New Zealand
State/province [1] 24814 0
Manawatu and Wellington regions

Funding & Sponsors
Funding source category [1] 311571 0
Government body
Name [1] 311571 0
The Tertiary Education Commission and the New Zealand Ministry of Education
Country [1] 311571 0
New Zealand
Primary sponsor type
University
Name
Riddet Institute, Massey University
Address
Massey University
Private Bag 11-222
Palmerston North 4442
Country
New Zealand
Secondary sponsor category [1] 312991 0
None
Name [1] 312991 0
Address [1] 312991 0
Country [1] 312991 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 311019 0
Massey University Human Ethics Committee
Ethics committee address [1] 311019 0
Ethics committee country [1] 311019 0
New Zealand
Date submitted for ethics approval [1] 311019 0
12/08/2020
Approval date [1] 311019 0
24/11/2020
Ethics approval number [1] 311019 0

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

Contacts
Principal investigator
Name 119718 0
Miss Anika Hoogeveen
Address 119718 0
The Riddet Institute
University Avenue, Fitzherbert, Palmerston North 4474
Country 119718 0
New Zealand
Phone 119718 0
+64 6 951 7295
Fax 119718 0
Email 119718 0
[email protected]
Contact person for public queries
Name 119719 0
Anika Hoogeveen
Address 119719 0
The Riddet Institute
University Avenue, Fitzherbert, Palmerston North 4474
Country 119719 0
New Zealand
Phone 119719 0
+64 6 951 7295
Fax 119719 0
Email 119719 0
[email protected]
Contact person for scientific queries
Name 119720 0
Anika Hoogeveen
Address 119720 0
The Riddet Institute
University Avenue, Fitzherbert, Palmerston North 4474
Country 119720 0
New Zealand
Phone 119720 0
+64 6 951 7295
Fax 119720 0
Email 119720 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
In reference to human ethical approval, all individual participant data will be accessible to the research team only so as to maintain confidentiality of identities.


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
No additional documents have been identified.