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A comparative study examining the in vitro fermentation by ileal microbiota obtained from human ileostomy subjects and an animal model

A comparative study examining the in vitro fermentation by ileal microbiota obtained from human ileostomy subjects and an animal model

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12622000813785
Enrollment
5
Registered
2022-06-09
Start date
2021-04-29
Completion date
2021-09-28
Last updated
2022-06-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

The limited accessibility to the human small intestine explains why fermentation and the role of the small intestinal microbiota have not been well studied. Recently, we have developed and optimized a combined in vivo/in vitro ileal fermentation method using a growing pig (Montoya et al., 2018. J Nutr, 148, 298) as a model for the adult human. This methodology has shown merit and contributed novel information to the field of human nutrition. This study aimed to validate the use of the pig as an animal model of the adult human for ileal fermentation by comparing the ileal microbiota and their capacity to ferment fibre between pigs and humans ileostomy subjects provided similar meals.

Interventions

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.

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.

Sponsors

Riddet Institute, Massey University
Lead SponsorUniversity

Study design

Allocation
Non-randomised trial
Primary purpose
Diagnosis

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years
Healthy volunteers
No

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.

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

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 6, 2026