Feeding DifficultiesPhase 4NCT07303738
The Use of High Bile-binding Foods to Reduce Upper Gastrointestinal Bile Acid Concentrations (Aim 1)
A Phase 4 study testing amino acid based formula (e.g. Elecare Jr), low bile acid binding blenderized diet (e.g. Kate Farms) and high bile acid binding blenderized diet in people with Feeding Difficulties and Aspiration, run by Boston Children's Hospital at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 5 to 21 years
- Conditions the study is for
- Feeding Difficulties, Aspiration, Gastrostomy
- What is being tested?
- amino acid based formula (e.g. Elecare Jr), low bile acid binding blenderized diet (e.g. Kate Farms) and high bile acid binding blenderized diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Dec 2025to 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
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Boston Children's Hospital
Boston, Massachusetts, 02115
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 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.
- Conditions
- Feeding Difficulties, Aspiration, Gastrostomy
- Being tested
- amino acid based formula (e.g. Elecare Jr), low bile acid binding blenderized diet (e.g. Kate Farms), 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 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 dietDrug
We will administer one bolus of a high bile acid binding blenderized diet
| Study group | Role | What they receive |
|---|---|---|
| amino acid-based formula (e.g., elecare, neocate) | Active comparator | Not described Receives: Drug: amino acid based formula (e.g. Elecare Jr) |
| low bile acid binding blenderized diet (e.g., real food blends) | Active comparator | Not described Receives: Drug: low bile acid binding blenderized diet (e.g. Kate Farms) |
| high bile acid binding blenderized diet (proprietary) | Experimental | 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.
Gastric bile acid concentration
Mean difference in gastric bile acid concentrations between start of feed and four hours following feed
Measured: 4 hours
Secondary outcomes (5)
Gastric bile acid concentration
Differences in gastric bile acid concentrations from start of feed to 1, 2 and 3 hours after feed between groups
Measured: 1, 2 and 3 hours
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
Measured: Baseline to 1, 2, 3 and 4 hours post-prandial
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
Measured: baseline
Correlation of gastric and salivary bile acid concentrations
correlations between gastric and salivary bile acid concentrations at each time point
Measured: 0, 1, 2, 3 and 4 hours post-prandial
correlations between C13 excretion rates and gastric and salivary bile acid concentrations
correlations between C13 excretion rates and gastric and salivary bile acid concentrations
Measured: Baseline to 1, 2, 3 and 4 hours post-prandial
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 start1 Dec 2025
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 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
- NCT07303738
- Sponsor's protocol ID
- IRB-P00049734 Aim 1
- 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
- Expanded access
- Available
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 1)
- ClinicalTrials.gov ID
- NCT07303738
- Acronym / sponsor ID
- IRB-P00049734 Aim 1
- Conditions
- Feeding Difficulties, Aspiration, Gastrostomy
- Keywords
- blenderized, bile acid, gastrostomy, aspiration
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Boston Children's HospitalUniversity, hospital or other
- Study start
- 1 Dec 2025 (actual)
- 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.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| amino acid-based formula (e.g., elecare, neocate) | Active comparator | Drug: amino acid based formula (e.g. Elecare Jr) |
| low bile acid binding blenderized diet (e.g., real food blends) | Active comparator | Drug: low bile acid binding blenderized diet (e.g. Kate Farms) |
| high bile acid binding blenderized diet (proprietary) | Experimental | 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
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- 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.
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 based formula (e.g. Elecare Jr)We will administer one bolus of an amino acid based formula | Drug | amino acid-based formula (e.g., elecare, neocate) |
| low bile acid binding blenderized diet (e.g. Kate Farms)We will administer one bolus of a low bile acid binding blenderized diet | Drug | low bile acid binding blenderized diet (e.g., real food blends) |
| high bile acid binding blenderized dietWe will administer one bolus of a high bile acid binding blenderized diet | Drug | high bile acid binding blenderized diet (proprietary) |
Primary outcome
Gastric bile acid concentration
Time frame: 4 hours
Mean difference in gastric bile acid concentrations between start of feed and four hours following feed
5 secondary outcomes
Gastric bile acid concentration
Time frame: 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
Correlation of symptom scores with gastric and salivary bile acid concentration
Time frame: baseline
Correlation of gastric and salivary bile acid concentrations
Time frame: 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
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing amino acid based formula (e.g. Elecare Jr), low bile acid binding blenderized diet (e.g. Kate Farms) and high bile acid binding blenderized diet in people with Feeding Difficulties and Aspiration, run by Boston Children's Hospital at 1 site in United States.
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 5 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: looking for participants now, 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.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Contact Rachel Rosen (617-355-0897, rachel.rosen@childrens.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gastric bile acid concentration (time frame: 4 hours). 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.