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NCT Number: NCT07303738

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

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.

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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

Primary location

Boston Children's Hospital

Boston, Massachusetts, 02115, United States

Location status: Recruiting

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

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

Drug

We will administer one bolus of an amino acid based formula

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

Drug

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

high bile acid binding blenderized diet

Drug

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

Primary outcomes

  1. Gastric bile acid concentration

    Time frame: 4 hours

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

Secondary outcomes

  1. Gastric bile acid concentration

    Time frame: 1, 2 and 3 hours

    Differences in gastric bile acid concentrations from start of feed to 1, 2 and 3 hours after feed between groups

  2. Correlations between gastric bile acid and gastroesophageal reflux Likert scale

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

    Correlations between the postprandial changes in gastric bile acid concentrations and gastroesophageal reflux Likert scores

  3. Correlation of symptom scores with gastric and salivary bile acid concentration

    Time frame: baseline

    comparison of PedsGIQL scores, GERD Likert scores, and PC-QoL scores with baseline gastric and salivary bile acid concentrations

  4. Correlation of gastric and salivary bile acid concentrations

    Time frame: 0, 1, 2, 3 and 4 hours post-prandial

    correlations between gastric and salivary bile acid concentrations at each time point

  5. correlations between C13 excretion rates and gastric and salivary bile acid concentrations

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

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

Study contacts

Contact information is provided by the study sponsor or research team.

Rachel Rosen

CONTACT

[email protected]

617-355-0897

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 1)

Important dates

Study start
2025
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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