The Use of High Bile-binding Foods to Reduce Upper Gastrointestinal Bile Acid Concentrations (Aim 2) (NCT07303868) | Clinical Trial Compass
Not Yet RecruitingPhase 4
The Use of High Bile-binding Foods to Reduce Upper Gastrointestinal Bile Acid Concentrations (Aim 2)
66 participantsStarted 2026-07
Plain-language summary
Using a four-week randomized, crossover study design, we will assess the impact of 2 weeks of a high bile acid-binding blenderized diet, compared to 2 weeks of a low bile acid-binding blenderized diet, on gastric and salivary bile acid concentrations within individual participants. Four weeks of an amino acid formula will be a comparator group.
Who can participate
Age range
5 Years – 21 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.
Pediatric patients ages 5 to 21 in the randomized arm Inclusion criteria
* receive at least 80% of their nutritional needs via gastrostomy
* receive blenderized feeds or will start receiving blenderized feeds
* have no known allergies to ingredients in blenderized feeds;
* receive their bolus feeds within 30 minutes or less
* can receive their feeds by syringe push Exclusion criteria
* have undergone anti-reflux surgery
* receive post-pyloric feeds
* are allergic to any component of the administered diets
* cannot receive their gastrostomy feeds over 30 minutes
* require a feeding pump for feed administration (as the H-BBB is too thick for pump administration).
Pediatric patients ages 5 to 21 in the observational arm Inclusion
* receive at least 80% of their nutritional needs via gastrostomy
* are taking an amino acid formula
* have not undergone antireflux surgery Exclusion
* have undergone anti-reflux surgery
* receive post-pyloric feeds
* are not receiving an amino acid-based formula.
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
Gastric bile acid concentration
Timeframe: after 2 weeks on each of 2 diets (cross-over design)