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

Launched by BOSTON CHILDREN'S HOSPITAL · Mar 29, 2025

Keywords

ClinConnect Summary

This clinical trial is studying how different types of diets can affect people who have feeding difficulties, particularly those who receive their nutrition through a gastrostomy tube (a tube placed in the stomach). Specifically, the trial will compare a high bile acid-binding diet, a low bile acid-binding diet, and an amino acid-based formula to see how they affect hospital visits and emergency room rates related to gastrointestinal (digestive) and pulmonary (lung) issues over six months.

To be eligible for this study, participants need to be between the ages of 18 and 70 and must receive at least 80% of their nutrition through a gastrostomy tube. They should be using a specific type of feeding blend that meets certain standards. However, people who have had certain surgeries, like anti-reflux surgery, or those who take regular antibiotics, will not be able to participate. If someone joins the study, they can expect to follow one of the diets for six months and help researchers understand how diet impacts their overall health and well-being.

Gender

ALL

Eligibility criteria

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