Feeding DifficultiesNCT06913621
The Use of High Bile-Binding Foods to Reduce Upper Gastrointestinal Bile Acid Concentrations (Aim 3)
An observational study of Feeding Difficulties and Gastrostomy, run by Boston Children's Hospital.
Trial 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. Read more about this study
- Who is it for?
- Ages 5 to 21 years
- Conditions the study is for
- Feeding Difficulties, Gastrostomy, Aspiration
- What is being tested?
- amino acid formula, low bile acid binding blenderized diet and high bile acid binding blenderized diet
- How many people
- 138 participants
- Where
- No sites listed yet
- Study dates
- Oct 2026to Aug 2030
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Children requiring gastrostomy tube feeds for feeding difficulties
Who may be able to join
- 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.
Who cannot join
- have undergone anti-reflux surger
- receive post-pyloric feeds
- receive regular daily prophylactic antibiotics.
About this study
Official title: 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 3)
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
- Being tested
- amino acid formula, low bile acid binding blenderized diet, high bile acid binding blenderized diet
- Keywords
- blenderized, bile acid, gastrostomy, aspiration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
amino acid formulaDrug
amino acid formula for 6 months
low bile acid binding blenderized dietDrug
low bile acid binding blenderized diet for 6 months
high bile acid binding blenderized dietDrug
high bile acid binding blenderized diet for 6 months
| Study group | Role | What they receive |
|---|---|---|
| amino acid-based formula | Not described Receives: Drug: amino acid formula | |
| Low bile binding blenderized diet | Not described Receives: Drug: low bile acid binding blenderized diet | |
| High bile binding blenderized diet | Not described Receives: Drug: high bile acid binding blenderized diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 6 months
Secondary outcomes (5)
differences in pulmonary, gastrointestinal or ICU admission rates
differences in pulmonary, gastrointestinal or ICU admission rates between diets
Measured: 6 months
differences in bile acid concentrations
differences in bile acid concentrations between diets
Measured: 6 months
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
Measured: 6 months
differences in metagenomic patterns between diets
Measured: 6 months
correlations between admission rates by diet type and short chain fatty acid concentrations
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2025
- Study startOct 2026 (estimated)
- Primary completionAug 2030 (estimated)
- Study completionAug 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Feeding DifficultiesStudies of the same condition, open and under way.
- More trials run by Boston Children's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 138 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Boston Children's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rachel Rosen, Boston Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06913621
- Sponsor's protocol ID
- IRB-P00049734 Aim 3
- Status last verified
- Jul 2026
- First submitted
- 29 Mar 2025
- Last updated
- 3 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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 3)
- ClinicalTrials.gov ID
- NCT06913621
- Acronym / sponsor ID
- IRB-P00049734 Aim 3
- Conditions
- Feeding Difficulties, Gastrostomy, Aspiration
- Keywords
- blenderized, bile acid, gastrostomy, aspiration
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 138 participants (estimated)
- Lead sponsor
- Boston Children's HospitalUniversity, hospital or other
- Study start
- Oct 2026 (estimated)
- Primary completion
- Aug 2030 (estimated)
- Study completion
- Aug 2030 (estimated)
- First posted
- 6 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| amino acid-based formula | – | Drug: amino acid formula |
| Low bile binding blenderized diet | – | Drug: low bile acid binding blenderized diet |
| High bile binding blenderized diet | – | Drug: high bile acid binding blenderized diet |
Who may qualify
- Ages
- 5 to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Children requiring gastrostomy tube feeds for feeding difficulties
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- have undergone anti-reflux surger
- receive post-pyloric feeds
- receive regular daily prophylactic antibiotics.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| amino acid formulaamino acid formula for 6 months | Drug | amino acid-based formula |
| low bile acid binding blenderized dietlow bile acid binding blenderized diet for 6 months | Drug | Low bile binding blenderized diet |
| high bile acid binding blenderized diethigh bile acid binding blenderized diet for 6 months | Drug | High bile binding blenderized diet |
Primary outcome
total hospitalization and emergency room visits rates
Time frame: 6 months
total hospitalization and emergency room visits rates between participants receiving H-BBB and those receiving L-BBB or an amino acid-based formula
5 secondary outcomes
differences in pulmonary, gastrointestinal or ICU admission rates
Time frame: 6 months
differences in bile acid concentrations
Time frame: 6 months
correlations between microbial abundance and diversity and hospitalization and emergency room visit rates
Time frame: 6 months
differences in metagenomic patterns between diets
Time frame: 6 months
correlations between admission rates by diet type and short chain fatty acid concentrations
Time frame: 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Feeding Difficulties and Gastrostomy, run by Boston Children's Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 3 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
total hospitalization and emergency room visits rates (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2026.