The Use of High Bile-binding Foods to Reduce Upper Gastrointestinal Bile Acid Concentrations (Aim 1)

Phase 4RecruitingNCT07303738

Boston Children's Hospital60 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

NONE

Enrollment

Conditions

Feeding Difficulties Aspiration Gastrostomy

Interventions

amino acid based formula (e.g. Elecare Jr)DRUG

We will administer one bolus of an amino acid based formula

low bile acid binding blenderized diet (e.g. Kate Farms)DRUG

We will administer one bolus of a low bile acid binding blenderized diet

high bile acid binding blenderized dietDRUG

We will administer one bolus of a high bile acid binding blenderized diet

Eligibility

Sex: ALLMin age: 5 YearsMax age: 21 Years

Medical Language ↔ Plain English

Inclusion Criteria: * 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 Exclusion Criteria: * have received a fundoplication * receive post-pyloric feeds * require medication/flush administration during the four-hour study period * are allergic to any component of the study diets. To participate in this study, if patients are taking acid suppression or motility medications (e.g., erythromycin, azithromycin, prucalopride), they will need to stop these at least 72 hours prior to participation in this aim.

Outcomes

Primary Outcomes

Gastric bile acid concentration

Mean difference in gastric bile acid concentrations between start of feed and four hours following feed

Time frame: 4 hours

Secondary Outcomes

Gastric bile acid concentration

Differences in gastric bile acid concentrations from start of feed to 1, 2 and 3 hours after feed between groups

Time frame: 1, 2 and 3 hours

Correlations between gastric bile acid and gastroesophageal reflux Likert scale

Correlations between the postprandial changes in gastric bile acid concentrations and gastroesophageal reflux Likert scores

Time frame: Baseline to 1, 2, 3 and 4 hours post-prandial

Correlation of symptom scores with gastric and salivary bile acid concentration

comparison of PedsGIQL scores, GERD Likert scores, and PC-QoL scores with baseline gastric and salivary bile acid concentrations

Time frame: baseline

Correlation of gastric and salivary bile acid concentrations

correlations between gastric and salivary bile acid concentrations at each time point

Time frame: 0, 1, 2, 3 and 4 hours post-prandial

correlations between C13 excretion rates and gastric and salivary bile acid concentrations