Gastrostomy Clinical Trials

Clinical trials related to Gastrostomy Procedure

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)

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 5
Maximum Age: 21
Healthy Volunteers: f
View:

• 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

Locations
United States
Massachusetts
Boston Children's Hospital
RECRUITING
Boston
Contact Information
Primary
Rachel Rosen
rachel.rosen@childrens.harvard.edu
617-355-0897
Time Frame
Start Date: 2025-12-01
Estimated Completion Date: 2030-08
Participants
Target number of participants: 60
Treatments
Active_comparator: amino acid-based formula (e.g., elecare, neocate)
Active_comparator: low bile acid binding blenderized diet (e.g., real food blends)
Experimental: high bile acid binding blenderized diet (proprietary)
Related Therapeutic Areas
Sponsors
Leads: Boston Children's Hospital

This content was sourced from clinicaltrials.gov