High bile-binding foods to reduce bile acids in the upper digestive tract
Official title: The Use of High Bile-Binding Foods to Reduce Upper Gastrointestinal Bile Acid Concentrations: A Novel Intervention for Children at Risk for Aspiration-Associated Complications (Aim 1)
Run by Boston Children's Hospital · NCT07303738 · Data updated 2026-11-12
This test will see if different gastrostomy tube feeds—a standard amino acid formula, a low bile‑binding blended feed, or a high bile‑binding blended feed—lower bile acid levels in the stomach and saliva of people who get most of their nutrition through a gastrostomy.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Ages | 5 Years to 21 Years |
| Sex | All |
| Enrollment | 60 (estimated) |
| Sponsor | Boston Children's Hospital Academic / other |
| Locations | 1 site (Boston, Massachusetts) |
| Status | Recruiting |
| Started | December 1, 2025 |
| Main results expected | August 2030 |
| Study ends | August 2030 |
| Registry record updated | August 3, 2026 |
| Trial ID | NCT07303738 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
People (typically pediatric patients) who receive at least 80% of their nutrition by gastrostomy, can tolerate a 240 mL bolus within 30 minutes, and currently use either an amino acid formula or blenderized feeds are ideal candidates.
✕Probably not a fit
Patients who have had a fundoplication, receive post‑pyloric feeds, require medications or flushes during the four‑hour study period, are allergic to study diet components, or cannot stop acid suppression/motility drugs 72 hours prior are unlikely to be eligible or benefit from participation.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is an acute physiology comparison of three tube-feed types given as a bolus through a gastrostomy: an amino acid–based formula, a low bile‑binding blenderized feed, and a high bile‑binding blenderized feed. Participants who normally receive commercial amino acid formula will receive that formula, while those on blenderized feeds will be randomized to receive either the low or high bile‑binding blenderized feed. Gastric and salivary bile acid concentrations will be measured over a four‑hour post‑prandial period to compare how each feed changes upper GI bile exposure. Study visits require a single in‑person feeding and sample collection session with medication washout requirements for acid suppression or prokinetic drugs.
Why it matters
Potential benefit: If successful, switching to a high bile‑binding blenderized feed could reduce upper GI bile acid exposure and potentially lower the risk of aspiration‑related lung injury or symptoms.
How similar studies have gone: This feeding‑based bile‑binding approach is relatively novel and there are limited prior clinical trials directly testing whether high bile‑binding blenderized feeds reduce gastric or salivary bile acids.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * receive at least 80% of their nutritional needs by gastrostomy * receive either an amino acid-based formula, an International Dysphagia Diet Standardization Initiative level 4 commercial blend, or a home blend * can receive bolus feeds of 240 cc within 30 minutes or less Exclusion Criteria: * have received a fundoplication * receive post-pyloric feeds * require medication/flush administration during the four-hour study period * are allergic to any component of the study diets. To participate in this study, if patients are taking acid suppression or motility medications (e.g., erythromycin, azithromycin, prucalopride), they will need to stop these at least 72 hours prior to participation in this aim.
Where it's running
-
Boston Children's Hospital
Boston, Massachusetts, United States Recruiting
Study contacts
- Study coordinator: Rachel Rosen
- Email: rachel.rosen@childrens.harvard.edu
- Phone: 617-355-0897
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.