Health TrialsbyHealthPanel

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

ConditionsFeeding DifficultiesAspirationGastrostomy
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age5-21
SponsorBoston Children's Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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 diet

    Drug

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

Treatment groups

60 Participants
are divided into 3 treatment groups
Group A: amino acid-based formula (e.g., elecare, neocate)Active comparator 1 intervention
Group B: low bile acid binding blenderized diet (e.g., real food blends)Active comparator 1 intervention
Group C: high bile acid binding blenderized diet (proprietary)Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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

1

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
2

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
3

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
4

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

Other outcomes

Sponsors and contacts

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

Boston Children's Hospital

Lead sponsor

Source ClinicalTrials.gov
Apply now