The Use of High Bile-binding Foods to Reduce Upper Gastrointestinal Bile Acid Concentrations (Aim 1)
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 1)
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 Overview
Status
Conditions
Study Type
Enrollment (Estimated)
Phase
- Phase 4
Contacts and Locations
Study Contact
- Name: Rachel Rosen
- Phone Number: 617-355-0897
- Email: rachel.rosen@childrens.harvard.edu
Study Locations
-
-
Massachusetts
-
Boston, Massachusetts, United States, 02115
- Recruiting
- Boston Children's Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: amino acid-based formula (e.g., elecare, neocate)
|
We will administer one bolus of an amino acid based formula
|
|
Active Comparator: low bile acid binding blenderized diet (e.g., real food blends)
|
We will administer one bolus of a low bile acid binding blenderized diet
|
|
Experimental: high bile acid binding blenderized diet (proprietary)
|
We will administer one bolus of a high bile acid binding blenderized diet
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Gastric bile acid concentration
Time Frame: 4 hours
|
Mean difference in gastric bile acid concentrations between start of feed and four hours following feed
|
4 hours
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Gastric bile acid concentration
Time Frame: 1, 2 and 3 hours
|
Differences in gastric bile acid concentrations from start of feed to 1, 2 and 3 hours after feed between groups
|
1, 2 and 3 hours
|
|
Correlations between gastric bile acid and gastroesophageal reflux Likert scale
Time Frame: Baseline to 1, 2, 3 and 4 hours post-prandial
|
Correlations between the postprandial changes in gastric bile acid concentrations and gastroesophageal reflux Likert scores
|
Baseline to 1, 2, 3 and 4 hours post-prandial
|
|
Correlation of symptom scores with gastric and salivary bile acid concentration
Time Frame: baseline
|
comparison of PedsGIQL scores, GERD Likert scores, and PC-QoL scores with baseline gastric and salivary bile acid concentrations
|
baseline
|
|
Correlation of gastric and salivary bile acid concentrations
Time Frame: 0, 1, 2, 3 and 4 hours post-prandial
|
correlations between gastric and salivary bile acid concentrations at each time point
|
0, 1, 2, 3 and 4 hours post-prandial
|
|
correlations between C13 excretion rates and gastric and salivary bile acid concentrations
Time Frame: Baseline to 1, 2, 3 and 4 hours post-prandial
|
correlations between C13 excretion rates and gastric and salivary bile acid concentrations
|
Baseline to 1, 2, 3 and 4 hours post-prandial
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- IRB-P00049734 Aim 1
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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