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The Use of High Bile-Binding Foods to Reduce Upper Gastrointestinal Bile Acid Concentrations (Aim 3)

ConditionsFeeding DifficultiesGastrostomyAspiration
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age5-21
SponsorBoston Children's Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

receive at least 80% of their nutritional needs via gastrostomy

receive an International Dysphagia Diet Standardization Initiative level 4 commercial blend, home blend or amino acid-based formula

receive their bolus feeds within 30 minutes or less.

Disqualifiers

have undergone anti-reflux surger

receive post-pyloric feeds

receive regular daily prophylactic antibiotics.

Trial population

Children requiring gastrostomy tube feeds for feeding difficulties

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • amino acid formula

    Drug

    amino acid formula for 6 months

  • low bile acid binding blenderized diet

    Drug

    low bile acid binding blenderized diet for 6 months

  • high bile acid binding blenderized diet

    Drug

    high bile acid binding blenderized diet for 6 months

Treatment groups

138 Participants
are divided into 3 treatment groups
Group A: amino acid-based formula1 intervention
Group B: Low bile binding blenderized diet1 intervention
Group C: High bile binding blenderized diet1 intervention

Trial outcomes

Primary outcomes

1

total hospitalization and emergency room visits rates

total hospitalization and emergency room visits rates between participants receiving H-BBB and those receiving L-BBB or an amino acid-based formula

Time frame
6 months

Secondary outcomes

1

differences in pulmonary, gastrointestinal or ICU admission rates

differences in pulmonary, gastrointestinal or ICU admission rates between diets

Time frame
6 months
2

differences in bile acid concentrations

differences in bile acid concentrations between diets

Time frame
6 months
3

correlations between microbial abundance and diversity and hospitalization and emergency room visit rates

correlations between microbial abundance and diversity and hospitalization and emergency room visit rates

Time frame
6 months
4

differences in metagenomic patterns between diets

Time frame
6 months

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Boston Children's Hospital

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: