The Use of High Bile-binding Foods to Reduce Upper Gastrointestinal Bile Acid Concentrations (Aim 2)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Low bile acid binding blenderized diet, High bile acid binding blenderized diet.
- Who it may be relevant to
- Registry conditions: Feeding Difficulties, Gastrostomy, Aspiration. Basic parameters: 5 years — 21 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official 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 2)
Overview
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 of a low bile acid-binding blenderized diet, on gastric and salivary bile acid concentrations within individual participants. Four weeks of an amino acid formula will be a comparator group.
Interventions
- Drug Low bile acid binding blenderized diet
Low bile acid binding blenderized diet administered for 2 weeks - Drug High bile acid binding blenderized diet
High bile acid binding blenderized diet administered for 2 weeks
Primary outcome measures
- Gastric bile acid concentration [Time frame: after 2 weeks on each of 2 diets (cross-over design)]
Secondary outcome measures (5)
- Gastric bile acid concentration [Time frame: after 2 weeks on each of 2 diets (cross-over design)]
- Symptom scores [Time frame: after 2 weeks on each of 2 diets (cross-over design)]
- Salivary and stool bile acid concentrations [Time frame: after 2 weeks on each of 2 diets (cross-over design)]
- Serum complement 4 (C4) [Time frame: after 2 weeks on each of 2 diets (cross-over design)]
- gastric, salivary, and stool bile acid [Time frame: after 2 weeks on each of 2 diets (cross-over design)]
Eligibility criteria
Pediatric patients ages 5 to 21 in the randomized arm Inclusion criteria
- receive at least 80% of their nutritional needs via gastrostomy
- receive blenderized feeds or will start receiving blenderized feeds
- have no known allergies to ingredients in blenderized feeds;
- receive their bolus feeds within 30 minutes or less
- can receive their feeds by syringe push Exclusion criteria
- have undergone anti-reflux surgery
- receive post-pyloric feeds
- are allergic to any component of the administered diets
- cannot receive their gastrostomy feeds over 30 minutes
- require a feeding pump for feed administration (as the H-BBB is too thick for pump administration).
Pediatric patients ages 5 to 21 in the observational arm Inclusion
- receive at least 80% of their nutritional needs via gastrostomy
- are taking an amino acid formula
- have not undergone antireflux surgery Exclusion
- have undergone anti-reflux surgery
- receive post-pyloric feeds
- are not receiving an amino acid-based formula.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Crossover
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07303868 · IRB-P00049734 Aim 2