The Use of High Bile-Binding Foods to Reduce Upper Gastrointestinal Bile Acid Concentrations (Aim 3)
NCT06913621 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 138
Last updated 2025-12-30
Summary
Using a longitudinal cohort design, we will compare the impact of a high BA-binding blenderized diet compared to a low BA-binding blenderized diet and an amino acid-based formula, on gastrointestinal and pulmonary hospitalization and emergency room visit rates over six months.
Conditions
- Feeding Difficulties
- Gastrostomy
- Aspiration
Interventions
- DRUG
-
amino acid formula
amino acid formula for 6 months
- DRUG
-
low bile acid binding blenderized diet
low bile acid binding blenderized diet for 6 months
- DRUG
-
high bile acid binding blenderized diet
high bile acid binding blenderized diet for 6 months
Sponsors & Collaborators
- lead OTHER
Eligibility
- Min Age
- 5 Years
- Max Age
- 21 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2026-07-31
- Primary Completion
- 2030-08-31
- Completion
- 2030-08-31
- FDA Drug
- Yes
More Related Trials
-
Comparison of Smoflipid to Soy-based Lipid Reduction for Cholestasis Prevention in Surgical Neonates
NCT03387579 ·Status: COMPLETED ·Phase: PHASE3
-
Term Infants Fed a Partially Hydrolyzed Whey Protein-Based Formula
NCT04934397 ·Status: TERMINATED ·Phase: NA
-
Retrospective Review of Amino Acid Formula Use at a Children's Center
NCT03497091 ·Status: COMPLETED
-
Re-feeding Gastric Residuals in Preterm Infants
NCT01420263 ·Status: COMPLETED ·Phase: NA
-
Tube Feeding Tolerance After Switch to Peptide Based Formula in Children With Developmental Delay
NCT02912065 ·Status: COMPLETED
-
Tolerance of Healthy Term Infants Fed Infant Formulas
NCT00705562 ·Status: COMPLETED ·Phase: PHASE2
-
Efficacy and Safety of Bile Salt Stimulated Lipase (BSSL) as Replacement Therapy in Pasteurized Breast Milk for Preterm Infants
NCT00659243 ·Status: COMPLETED ·Phase: PHASE2
-
Comparison of rhBSSL With Placebo When Added to Infant Formula or Pasteurized Breast Milk During 4 Weeks of Treatment in Preterm Infants
NCT01413581 ·Status: TERMINATED ·Phase: PHASE3
-
Nutritional Study in Preterm Infants
NCT00707837 ·Status: COMPLETED ·Phase: PHASE3
-
Growth and Tolerance of Young Infants
NCT03276884 ·Status: COMPLETED ·Phase: NA
-
Prolonged Minimal Enteral Nutrition Versus Slowly Advancing Enteral Nutrition in Very Low Birth Weight Infants:
NCT02913677 ·Status: COMPLETED ·Phase: NA
-
Efficacy of a New Thickened Extensively Hydrolyzed Formula
NCT01985607 ·Status: COMPLETED ·Phase: NA
-
The Impact of Commercial Blenderized Formula on Caloric Needs, Gastrointestinal Symptoms, and Gut Microbiome in Children With Cerebral Palsy (CP)
NCT06488560 ·Status: NOT_YET_RECRUITING ·Phase: NA
-
Hepatic Function and Bile Acid in Preterm Infants Receiving Parenteral Lipids Emulsion
NCT01786759 ·Status: UNKNOWN ·Phase: PHASE4
-
Tolerance of Healthy Term Infants Fed Infant Formulas #4
NCT01155414 ·Status: COMPLETED ·Phase: PHASE3
-
Continuous vs Bolus Protein (Protein Regimen Outcomes) in Critically Ill Children (Kids In Distress)
NCT06721923 ·Status: RECRUITING ·Phase: NA
-
High Medium-chain Triglyceride Nutritional Support in Infants With Biliary Atresia
NCT05072626 ·Status: RECRUITING
-
Feeding Tolerance in Preterm Infants
NCT00450697 ·Status: UNKNOWN
-
Evaluation of Tolerance, Efficacy and Safety of an Hydrolyzed Formula in Infants With IgE/Non-IgE Mediated CMA.
NCT06481280 ·Status: ACTIVE_NOT_RECRUITING ·Phase: NA
-
Early Provision of Enteral Microlipid and Fish Oil to Infants With Enterostomy
NCT01306838 ·Status: COMPLETED ·Phase: EARLY_PHASE1
-
A Double-blind Randomized Controlled Trial of a Thickened Amino-acid-based Formula in Children Allergic to Cow's Milk and to Protein Hydrolysates
NCT01940068 ·Status: COMPLETED ·Phase: NA
-
Oral Care in Infants With Gastroschisis
NCT03393832 ·Status: ACTIVE_NOT_RECRUITING
-
Comparative Gastrointestinal Tolerance of Various Infant Formulas in Healthy Term Infants
NCT00798382 ·Status: COMPLETED ·Phase: PHASE2/PHASE3
-
Infant Formula in Infants and Children With Cow's Milk Allergy
NCT06456541 ·Status: RECRUITING ·Phase: NA
-
A Study to Monitor the Use of an Amino Acid-Based Infant Formula
NCT02953223 ·Status: COMPLETED