MedDataX Logo

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

NCT ID: NCT07303738

Last Updated: 2025-12-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

PHASE4

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-12-01

Study Completion Date

2030-08-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Feeding Difficulties Aspiration Gastrostomy

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

blenderized bile acid gastrostomy aspiration

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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

Group Type ACTIVE_COMPARATOR

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

Intervention Type DRUG

We will administer one bolus of an amino acid based formula

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

Group Type ACTIVE_COMPARATOR

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

Intervention Type DRUG

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

high bile acid binding blenderized diet (proprietary)

Group Type EXPERIMENTAL

high bile acid binding blenderized diet

Intervention Type DRUG

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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

We will administer one bolus of an amino acid based formula

Intervention Type DRUG

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

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

Intervention Type DRUG

high bile acid binding blenderized diet

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

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

5 Years

Maximum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Boston Children's Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Rachel Rosen

Director, Aerodigestive Center

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Boston Children's Hospital

Boston, Massachusetts, United States

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

United States

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Rachel Rosen

Role: CONTACT

Phone: 617-355-0897

Email: [email protected]

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

IRB-P00049734 Aim 1

Identifier Type: -

Identifier Source: org_study_id