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NCT Number: NCT07303868

The Use of High Bile-binding Foods to Reduce Upper Gastrointestinal Bile Acid Concentrations (Aim 2)

Using a four-week randomized, crossover study design, we will assess the impact of 2 weeks of a high bile acid-binding blenderized diet, compared to 2 weeks of a low bile acid-binding blenderized diet, on gastric and salivary bile acid concentrations within individual participants. Four weeks of an amino acid formula will be a comparator group.

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Key information

Conditions

Feeding Difficulties Aspiration Gastrostomy

Age range

5 year–21 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Pediatric patients ages 5 to 21 in the randomized arm Inclusion criteria

  • receive at least 80% of their nutritional needs via gastrostomy
  • receive blenderized feeds or will start receiving blenderized feeds
  • have no known allergies to ingredients in blenderized feeds;
  • receive their bolus feeds within 30 minutes or less
  • can receive their feeds by syringe push Exclusion criteria
  • have undergone anti-reflux surgery
  • receive post-pyloric feeds
  • are allergic to any component of the administered diets
  • cannot receive their gastrostomy feeds over 30 minutes
  • require a feeding pump for feed administration (as the H-BBB is too thick for pump administration).

Pediatric patients ages 5 to 21 in the observational arm Inclusion

  • receive at least 80% of their nutritional needs via gastrostomy
  • are taking an amino acid formula
  • have not undergone antireflux surgery Exclusion
  • have undergone anti-reflux surgery
  • receive post-pyloric feeds
  • are not receiving an amino acid-based formula.

Treatment and study plan

Low bile acid binding blenderized diet

Drug

Low bile acid binding blenderized diet administered for 2 weeks

high bile acid binding blenderized diet

Drug

High bile acid binding blenderized diet administered for 2 weeks

Primary outcomes

  1. Gastric bile acid concentration

    Time frame: after 2 weeks on each of 2 diets (cross-over design)

    differences in total gastric bile acid concentrations at the end of each diet period

Secondary outcomes

  1. Gastric bile acid concentration

    Time frame: after 2 weeks on each of 2 diets (cross-over design)

    changes in gastric bile acid composition (e.g., change in the proportion of gastric conjugated:unconjugated bile acid) between diet periods

  2. Symptom scores

    Time frame: after 2 weeks on each of 2 diets (cross-over design)

    changes in symptoms over the two weeks between diet periods

  3. Salivary and stool bile acid concentrations

    Time frame: after 2 weeks on each of 2 diets (cross-over design)

    changes in the total salivary and stool BA concentrations between diet periods;

  4. Serum complement 4 (C4)

    Time frame: after 2 weeks on each of 2 diets (cross-over design)

    changes in serum C4 between diet periods

  5. gastric, salivary, and stool bile acid

    Time frame: after 2 weeks on each of 2 diets (cross-over design)

    changes in gastric, salivary, and stool bile acid over time between the high bile binding blend, low bile binding blend and amino acid-based formula groups.

Sponsors and collaborators

Lead sponsor

Boston Children's Hospital

Other

Registry information

Official study 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 2)

Important dates

Study start
2026
Primary completion
2030
Study completion
2030
First posted
Dec 26, 2025
Registry last updated
Dec 26, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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