The Use of High Bile-binding Foods to Reduce Upper Gastrointestinal Bile Acid Concentrations (Aim 1)

NCT07303738 | Recruiting Phase 4 DMC FDA Drug

• 1 other identifier: IRB-P00049734 Aim 1
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Feeding Difficulties; Aspiration; Gastrostomy

Keywords

blenderized; bile acid; gastrostomy; aspiration

Outcome Measures

Primary Outcomes (1)

• Gastric bile acid concentration

  Mean difference in gastric bile acid concentrations between start of feed and four hours following feed

  4 hours

Secondary Outcomes (5)

• Gastric bile acid concentration

  1, 2 and 3 hours

• Correlations between gastric bile acid and gastroesophageal reflux Likert scale

  Baseline to 1, 2, 3 and 4 hours post-prandial

• Correlation of symptom scores with gastric and salivary bile acid concentration

  baseline

• Correlation of gastric and salivary bile acid concentrations

  0, 1, 2, 3 and 4 hours post-prandial

• correlations between C13 excretion rates and gastric and salivary bile acid concentrations

  Baseline to 1, 2, 3 and 4 hours post-prandial

Study Arms (3)

amino acid-based formula (e.g., elecare, neocate)

ACTIVE COMPARATOR

Drug: amino acid based formula (e.g. Elecare Jr)

low bile acid binding blenderized diet (e.g., real food blends)

ACTIVE COMPARATOR

Drug: low bile acid binding blenderized diet (e.g. Kate Farms)

high bile acid binding blenderized diet (proprietary)

EXPERIMENTAL

Drug: high bile acid binding blenderized diet

Interventions

amino acid based formula (e.g. Elecare Jr) DRUG

We will administer one bolus of an amino acid based formula

amino acid-based formula (e.g., elecare, neocate)

low bile acid binding blenderized diet (e.g. Kate Farms) DRUG

We will administer one bolus of a low bile acid binding blenderized diet

low bile acid binding blenderized diet (e.g., real food blends)

high bile acid binding blenderized diet DRUG

We will administer one bolus of a high bile acid binding blenderized diet

high bile acid binding blenderized diet (proprietary)

Eligibility Criteria

• Age: 5 Years - 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Boston Children's Hospital: lead

Study Sites (1)

Boston Children's Hospital

Boston, Massachusetts, 02115, United States

RECRUITING

Central Study Contacts

Rachel Rosen

CONTACT

617-355-0897; rachel.rosen@childrens.harvard.edu

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Aerodigestive Center
• Expanded Access: Yes

Study Record Dates

• First Submitted: March 29, 2025
• First Posted: December 26, 2025
• Study Start: December 1, 2025
• Primary Completion (Estimated): August 1, 2030
• Study Completion (Estimated): August 1, 2030
• Last Updated: December 26, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)