NCT07303738 The Use of High Bile-binding Foods to Reduce Upper Gastrointestinal Bile Acid Concentrations (Aim 1)
| NCT ID | NCT07303738 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Boston Children's Hospital |
| Condition | Feeding Difficulties |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2025-12-01 |
| Primary Completion | 2030-08 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 60 participants in total. It began in 2025-12-01 with a primary completion date of 2030-08.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
We will perform an acute physiology study comparing three different diets-an amino acid-based formula, a low bile acid-binding blenderized diet, or a high bile acid-binding blenderized diet administered through gastrostomy tube. We will determine the differences in gastric and salivary bile acid concentrations between participants over the 4 hour post-prandial timeframe. Participants who regularly receive an amino acid-based formula will receive an amino acid-based formula during the study and participants who regularly receive a blenderized feed will receive a blenderized feed during the study. Only participants who regularly receive blenderized feeds will be randomized to receive either the high or low bile acid binding blenderized feed.
Eligibility 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07303738 clinical trial?
This trial is open to participants of all sexes, aged 5 Years or older, up to 21 Years, studying Feeding Difficulties. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07303738 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT07303738 currently recruiting?
Yes, NCT07303738 is actively recruiting participants. Contact the research team at rachel.rosen@childrens.harvard.edu for enrollment information.
Where is the NCT07303738 trial being conducted?
This trial is being conducted at Boston, United States.
Who is sponsoring the NCT07303738 clinical trial?
NCT07303738 is sponsored by Boston Children's Hospital. The trial plans to enroll 60 participants.