Feeding DifficultiesPhase 4NCT07303868
The Use of High Bile-binding Foods to Reduce Upper Gastrointestinal Bile Acid Concentrations (Aim 2)
A Phase 4 study testing Low bile acid binding blenderized diet and High bile acid binding blenderized diet in people with Feeding Difficulties and Gastrostomy, run by Boston Children's Hospital.
Trial summary
Using a four-week randomized, crossover study design, we will assess the impact of 2 weeks of a high bile acid-binding blenderized diet, compared to 2 weeks of a low bile acid-binding blenderized diet, on gastric and salivary bile acid concentrations within individual participants. 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?
- Low bile acid binding blenderized diet and High bile acid binding blenderized diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- No sites listed yet
- Study dates
- Oct 2026to Aug 2030
- Phase
- Phase 4
- 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
Pediatric patients ages 5 to 21 in the randomized arm Inclusion criteria
- receive at least 80% of their nutritional needs via gastrostomy
- receive blenderized feeds or will start receiving blenderized feeds
- have no known allergies to ingredients in blenderized feeds;
- receive their bolus feeds within 30 minutes or less
- can receive their feeds by syringe push Exclusion criteria
- have undergone anti-reflux surgery
- receive post-pyloric feeds
- are allergic to any component of the administered diets
- cannot receive their gastrostomy feeds over 30 minutes
- require a feeding pump for feed administration (as the H-BBB is too thick for pump administration).
Pediatric patients ages 5 to 21 in the observational arm Inclusion
- receive at least 80% of their nutritional needs via gastrostomy
- are taking an amino acid formula
- have not undergone antireflux surgery Exclusion
- have undergone anti-reflux surgery
- receive post-pyloric feeds
- are not receiving an amino acid-based formula.
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 2)
Using a four-week randomized, crossover study design, we will assess the impact of 2 weeks of a high bile acid-binding blenderized diet, compared to 2 weeks of a low bile acid-binding blenderized diet, on gastric and salivary bile acid concentrations within individual participants. Four weeks of an amino acid formula will be a comparator group.
- Conditions
- Feeding Difficulties, Gastrostomy, Aspiration
- Being tested
- 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.
Low bile acid binding blenderized dietDrug
Low bile acid binding blenderized diet administered for 2 weeks
High bile acid binding blenderized dietDrug
High bile acid binding blenderized diet administered for 2 weeks
| Study group | Role | What they receive |
|---|---|---|
| Low bile binding then high bile binding blenderized diets | Experimental | 2 weeks of low bile binding then 2 weeks of high bile binding blenderized diets Receives: Drug: Low bile acid binding blenderized diet; Drug: High bile acid binding blenderized diet |
| High bile binding then low bile binding blenderized diets | Experimental | 2 weeks of high bile binding then 2 weeks of low bile binding blenderized diets Receives: Drug: Low bile acid binding blenderized diet; Drug: High bile acid binding blenderized diet |
| amino acid-based formula | No intervention | Observational arm |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gastric bile acid concentration
differences in total gastric bile acid concentrations at the end of each diet period
Measured: after 2 weeks on each of 2 diets (cross-over design)
Secondary outcomes (5)
Gastric bile acid concentration
changes in gastric bile acid composition (e.g., change in the proportion of gastric conjugated:unconjugated bile acid) between diet periods
Measured: after 2 weeks on each of 2 diets (cross-over design)
Symptom scores
changes in symptoms over the two weeks between diet periods
Measured: after 2 weeks on each of 2 diets (cross-over design)
Salivary and stool bile acid concentrations
changes in the total salivary and stool BA concentrations between diet periods;
Measured: after 2 weeks on each of 2 diets (cross-over design)
Serum complement 4 (C4)
changes in serum C4 between diet periods
Measured: after 2 weeks on each of 2 diets (cross-over design)
gastric, salivary, and stool bile acid
changes in gastric, salivary, and stool bile acid over time between the high bile binding blend, low bile binding blend and amino acid-based formula groups.
Measured: after 2 weeks on each of 2 diets (cross-over design)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Dec 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 66 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
- NCT07303868
- Sponsor's protocol ID
- IRB-P00049734 Aim 2
- 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 2)
- ClinicalTrials.gov ID
- NCT07303868
- Acronym / sponsor ID
- IRB-P00049734 Aim 2
- Conditions
- Feeding Difficulties, Gastrostomy, Aspiration
- Keywords
- blenderized, bile acid, gastrostomy, aspiration
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 66 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
- 26 Dec 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 four-week randomized, crossover study design, we will assess the impact of 2 weeks of a high bile acid-binding blenderized diet, compared to 2 weeks of a low bile acid-binding blenderized diet, on gastric and salivary bile acid concentrations within individual participants. Four weeks of an amino acid formula will be a comparator group.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Low bile binding then high bile binding blenderized diets | Experimental | Drug: Low bile acid binding blenderized diet, Drug: High bile acid binding blenderized diet2 weeks of low bile binding then 2 weeks of high bile binding blenderized diets |
| High bile binding then low bile binding blenderized diets | Experimental | Drug: Low bile acid binding blenderized diet, Drug: High bile acid binding blenderized diet2 weeks of high bile binding then 2 weeks of low bile binding blenderized diets |
| amino acid-based formula | No intervention | –Observational arm |
Who may qualify
- Ages
- 5 to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
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 |
|---|---|---|
| Low bile acid binding blenderized dietLow bile acid binding blenderized diet administered for 2 weeks | Drug | High bile binding then low bile binding blenderized diets, Low bile binding then high bile binding blenderized diets |
| High bile acid binding blenderized dietHigh bile acid binding blenderized diet administered for 2 weeks | Drug | High bile binding then low bile binding blenderized diets, Low bile binding then high bile binding blenderized diets |
Primary outcome
Gastric bile acid concentration
Time frame: after 2 weeks on each of 2 diets (cross-over design)
differences in total gastric bile acid concentrations at the end of each diet period
5 secondary outcomes
Gastric bile acid concentration
Time frame: after 2 weeks on each of 2 diets (cross-over design)
Symptom scores
Time frame: after 2 weeks on each of 2 diets (cross-over design)
Salivary and stool bile acid concentrations
Time frame: after 2 weeks on each of 2 diets (cross-over design)
Serum complement 4 (C4)
Time frame: after 2 weeks on each of 2 diets (cross-over design)
gastric, salivary, and stool bile acid
Time frame: after 2 weeks on each of 2 diets (cross-over design)
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?
A Phase 4 study testing Low bile acid binding blenderized diet and High bile acid binding blenderized diet in people with 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?
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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Gastric bile acid concentration (time frame: after 2 weeks on each of 2 diets (cross-over design)). 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.