High Bile-binding Foods for Feeding Difficulty
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores how different diets affect bile acid levels in individuals with feeding difficulties who use a gastrostomy tube. Participants will receive one of three diets: an amino acid-based formula, a low bile acid-binding blenderized diet, or a high bile acid-binding blenderized diet (high bile-binding foods). The goal is to understand how these diets impact bile acid levels in the stomach and saliva after eating. Individuals who primarily rely on a gastrostomy for nutrition and can handle quick feedings might be suitable for this trial. As a Phase 4 trial, this research involves an FDA-approved treatment and aims to understand its benefits for more patients.
Will I have to stop taking my current medications?
If you are taking acid suppression or motility medications, you will need to stop them at least 72 hours before participating in the study.
What is the safety track record for these treatments?
Research has shown that foods in blenderized diets, which help bind bile, are usually easy to digest. People on these diets often experience less stomach discomfort, such as retching and gagging, indicating that these foods are safe.
Amino acid-based formulas are also widely used and are gentle on the stomach, especially for those with specific dietary needs. Both blenderized diets and amino acid-based formulas have been tested in various settings, and their safety is well-documented.
In summary, both the bile-binding blenderized diet and the amino acid-based formula have a strong safety record. Participants in studies generally tolerated these diets well, with few side effects reported.12345Why are researchers enthusiastic about this study treatment?
Most treatments for feeding difficulties in children, like amino acid-based formulas (e.g., Elecare, Neocate) and low bile acid binding diets, focus on providing easily digestible nutrients. However, the high bile-binding blenderized diet being studied is different because it targets bile acid binding specifically. This unique approach could potentially help with nutrient absorption and gastrointestinal comfort by neutralizing excess bile acids. Researchers are excited about this treatment because it introduces a novel dietary strategy that might offer better symptom control and nutrition management for individuals with feeding challenges.
What evidence suggests that this trial's diets could be effective for feeding difficulty?
This trial will compare different dietary approaches for managing bile acid levels in individuals with feeding difficulties. Research has shown that certain foods can lower bile acid levels in the stomach, which might benefit those who struggle with eating. Participants may receive a high bile acid binding blenderized diet, which has shown potential in reducing stomach bile acid. Another group will receive a low bile acid binding blenderized diet, while a third group will receive an amino acid-based formula. Additionally, fiber in high bile-binding foods might help control bile acid by interacting with gut bacteria. These findings suggest that foods binding well with bile could help manage bile acid levels and improve eating difficulties.35678
Are You a Good Fit for This Trial?
This trial is for individuals who have difficulty with feeding or require a gastrostomy tube, and are currently on an amino acid-based formula or blenderized diet. It's not suitable for those who don't meet these dietary requirements.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive one of three 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
Follow-up
Participants are monitored for changes in gastric and salivary bile acid concentrations and correlations with gastroesophageal reflux and symptom scores
What Are the Treatments Tested in This Trial?
Interventions
- High Bile-binding Foods
Trial Overview
The study compares three diets delivered through a gastrostomy tube: an amino acid-based formula, a low bile acid-binding blenderized diet, and a high bile acid-binding blenderized diet to see how they affect bile acids in the stomach and saliva after eating.
How Is the Trial Designed?
3
Treatment groups
Experimental Treatment
Active Control
Find a Clinic Near You
Who Is Running the Clinical Trial?
Boston Children's Hospital
Lead Sponsor
Citations
The Use of High Bile-Binding Foods to Reduce Upper ...
Using a longitudinal cohort design, we will compare the impact of a high BA-binding blenderized diet compared to a low BA-binding blenderized ...
2.
trial.medpath.com
trial.medpath.com/clinical-trial/f98924710b7b7bcc/nct07303868-high-bile-binding-foods-reduce-gastrointestinal-bile-acid-children-aspirationThe Use of High Bile-binding Foods to Reduce Upper ...
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 ...
Dietary fiber-based regulation of bile salt hydrolase activity in ...
Dietary fiber is associated with bile acid deconjugation likely via an interaction between gut microbiota BSHs and GHs in the small intestine.
Effect of dietary bile acids supplementation on growth ...
This study aimed to evaluate the effects of dietary bile acids on growth performance, feed utilization, body composition, digestive enzyme ...
Steam cooking significantly improves in vitro bile acid ...
Steam cooking significantly improves in vitro bile acid binding of collard greens, kale, mustard greens, broccoli, green bell pepper, and cabbage.
Abstract - 2025 - JPGN Reports
We conducted secondary data analysis to test the hypothesis that children on blended diets would have improved tube weaning success. Methods: We ...
7.
trial.medpath.com
trial.medpath.com/clinical-trial/8eac444bfa690024/nct07303738-high-bile-binding-foods-reduce-gastrointestinal-bile-acid-children-aspirationThe Use of High Bile-binding Foods to Reduce Upper ...
We will perform an acute physiology study comparing three different diets-an amino acid-based formula, a low bile acid-binding blenderized diet ...
State‐of‐the‐art review of blenderized diets—Status and ...
Use of BTFs was associated with improved outcomes, including higher satisfaction, reduced gastroesophageal reflux, retching, gagging, ...
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