The Use of High Bile-Binding Foods to Reduce Upper Gastrointestinal Bile Acid Concentrations (Aim 3)

NCT06913621 | Not Yet Recruiting DMC FDA Drug

• 1 other identifier: IRB-P00049734 Aim 3
• Study Type: observational
• Target: 138
• Locations: 0 countries
• Sites: N/A

Brief Summary

Using a longitudinal cohort design, we will compare the impact of a high BA-binding blenderized diet compared to a low BA-binding blenderized diet and an amino acid-based formula, on gastrointestinal and pulmonary hospitalization and emergency room visit rates over six months.

Conditions

Feeding Difficulties; Gastrostomy; Aspiration

Keywords

blenderized; bile acid; gastrostomy; aspiration

Outcome Measures

Primary Outcomes (1)

• total hospitalization and emergency room visits rates

  total hospitalization and emergency room visits rates between participants receiving H-BBB and those receiving L-BBB or an amino acid-based formula

  6 months

Secondary Outcomes (5)

• differences in pulmonary, gastrointestinal or ICU admission rates

  6 months

• differences in bile acid concentrations

  6 months

• correlations between microbial abundance and diversity and hospitalization and emergency room visit rates

  6 months

• differences in metagenomic patterns between diets

  6 months

• correlations between admission rates by diet type and short chain fatty acid concentrations

  6 months

Study Arms (3)

amino acid-based formula

Drug: amino acid formula

Low bile binding blenderized diet

Drug: low bile acid binding blenderized diet

High bile binding blenderized diet

Drug: high bile acid binding blenderized diet

Interventions

amino acid formula DRUG

amino acid formula for 6 months

amino acid-based formula

low bile acid binding blenderized diet DRUG

low bile acid binding blenderized diet for 6 months

Low bile binding blenderized diet

high bile acid binding blenderized diet DRUG

high bile acid binding blenderized diet for 6 months

High bile binding blenderized diet

Eligibility Criteria

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

Study Population

Children requiring gastrostomy tube feeds for feeding difficulties

You may qualify if:

• receive at least 80% of their nutritional needs via gastrostomy
• receive an International Dysphagia Diet Standardization Initiative level 4 commercial blend, home blend or amino acid-based formula
• receive their bolus feeds within 30 minutes or less.

You may not qualify if:

• have undergone anti-reflux surger
• receive post-pyloric feeds
• receive regular daily prophylactic antibiotics.

Sponsors & Collaborators

• Boston Children's Hospital: lead

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Aerodigestive Center

Study Record Dates

• First Submitted: March 29, 2025
• First Posted: April 6, 2025
• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): August 1, 2030
• Study Completion (Estimated): August 1, 2030
• Last Updated: December 30, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share