High bile-binding foods to reduce bile acids in the upper digestive tract
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)
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 |
| Enrollment | 60 (estimated) |
| Ages | 5 Years to 21 Years |
| Sex | All |
| Sponsor | Boston Children's Hospital Academic / other |
| Locations | 1 site (Boston, Massachusetts) |
| Trial ID | NCT07303738 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Boston, Massachusetts
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.