Digestibility of Different Plant-based Proteins in Humans With Ileostomy (NCT06142084) | Clinical Trial Compass
RecruitingNot Applicable
Digestibility of Different Plant-based Proteins in Humans With Ileostomy
Sweden11 participantsStarted 2026-09
Plain-language summary
The goal of this interventional study is to learn about the digestibility of different plant-based proteins in adults (age 18-75) with an ileostomy.
The main questions the study aims to answer are:
1. How does the digestibility of proteins in the small intestine differ between different plant-based proteins?
2. Which proteins and amino acids are not digested or absorbed in the small intestine and are available for further metabolic processes in the large intestine?
3. How do metabolites in the collected content of the ileostomy bag differ after consuming different plant-based proteins?
4. Can the in vivo results be compared to results from existing in vitro models?
Participants will consume five different protein meals (oat protein - high bioavailable, oat protein - low bioavailable, pea protein - high bioavailable, pea protein low bioavailable, protein-free meal) on five different study days in a random order. Five hours after consuming the test meals ileostomy bags will be collected and the content will be analysed to answer the above mentioned research questions.
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Age: 18 - 75 years
* Body mass index: 18.5 - 30 kg/m2
* (double-loop) Ileostomy with an intact small bowel
* Signed informed consent
Exclusion Criteria:
* Pregnancy or breastfeeding
* Ileostomy \< 3 months before the study
* Any clinically significant present or past disease/condition other than colon cancer which in the investigator's opinion could interfere with the results of the trial
* Any clinically significant present or past medication which in the investigator's opinion could interfere with the results of the trial
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
True ileal digestibility of different plant-based proteins
Timeframe: 0-5 hours after consumption of test meal (on all 5 study days)