Enteral Feeding IntoleranceNCT04900597
Effect of Blenderized Enteral Tube Feeds on Pediatric Upper Gastrointestinal Tract Physiology
A study testing Elecare Jr, Nourish and Real Foods Blends in people with Enteral Feeding Intolerance, run by Boston Children's Hospital at 1 site in United States.
Trial summary
Blenderized diets consist of a wide range of table foods such as fruits, vegetables, meat and legumes, pureed in a blender and administered via gastrostomy tube. In a recent study, the investigators reported that children receiving blenderized feeds via gastrostomy had fewer total admissions and respiratory… Read more about this study
- Who is it for?
- Ages 1 year and older
- Conditions the study is for
- Enteral Feeding Intolerance
- What is being tested?
- Elecare Jr, Nourish and Real Foods Blends
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2021to Dec 2028
- Phase
- Interventional
- 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 1 year and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Age 1-21 years
- G-tube
- Able to tolerate bolus gastric feeds over 30 minutes
- Use of conventional enteral formula
- Undergoing impedance study for clinical purposes
Who cannot join
- History of allergy or intolerance to any component of the test diets
- History of Nissen fundoplication (participants with suspected or documented unwrapped fundoplication will be eligible for participation)
- Current use of non-invasive pressure support (continuous or bi-level positive airway pressure)
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
Bridget M Hron, MD, 6173551433, bridget.hron@childrens.harvard.edu
About this study
Blenderized diets consist of a wide range of table foods such as fruits, vegetables, meat and legumes, pureed in a blender and administered via gastrostomy tube. In a recent study, the investigators reported that children receiving blenderized feeds via gastrostomy had fewer total admissions and respiratory admissions, total emergency room visits, and improved gastrointestinal symptom scores compared to those fed formula. The goal of this project is to understand how these diets affect gastroesophageal reflux burden.
Read the detailed description
The investigators hypothesize that rates of gastroesophageal reflux will be lower in blenderized diets compared to formula. The investigators will determine if reflux burden as measured by multichannel intraluminal impedance/esophageal pH monitoring performed for clinical purposes differs between low viscosity conventional formula, medium viscosity commercial blenderized diet, and high viscosity commercial blenderized diet in 45 children receiving conventional formula via gastrostomy. All participants will receive each of the three test diets in random order in a 3-way crossover design. Results of gastric emptying scans will be recorded if done for clinical purposes.
- Conditions
- Enteral Feeding Intolerance
- Being tested
- Elecare Jr, Nourish, Real Foods Blends
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Elecare JrOther
Elecare Jr is a standard pediatric elemental formula
NourishOther
Nourish is a commercially prepared blenderized tube feed that is formulated for pediatric use
Real Foods BlendsOther
Real Foods Blends is a commercially prepared blenderized tube feed that is formulated for pediatric use
| Study group | Role | What they receive |
|---|---|---|
| Elecare - Nourish - Real Foods Blends | Experimental | Elecare for first bolus, Nourish for second bolus, Real Foods Blends for third bolus Receives: Other: Elecare Jr; Other: Nourish; Other: Real Foods Blends |
| Nourish - Real Foods Blends - Elecare | Experimental | Nourish for first bolus, Real Foods Blends for second bolus, Elecare for first bolus Receives: Other: Elecare Jr; Other: Nourish; Other: Real Foods Blends |
| Real Foods Blends - Elecare - Nourish | Experimental | Real Foods Blends for first bolus, Elecare for second bolus, Nourish for third bolus Receives: Other: Elecare Jr; Other: Nourish; Other: Real Foods Blends |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reflux episodes
Number of total reflux episodes (acid and non-acid) by impedance
Measured: 4 hours (following feed)
Secondary outcomes (4)
Full column reflux episodes
Total number of full-column reflux episodes by impedance
Measured: 4 hours (following feed)
Percent of time esophageal pH < 4
Percent of time esophageal pH < 4 by impedance
Measured: 4 hours after feed
Average height of refluxate
Average height of refluxate by impedance
Measured: 4 hours after feed
Number of symptoms
Frequency of pulmonary and gastrointestinal symptoms from questionnaires during impedance
Measured: 4 hours after feed
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2021
- Study start1 Aug 2021
- Primary completionDec 2027 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Enteral Feeding IntoleranceStudies 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 N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Boston Children's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bridget Hron, Boston Children's Hospital
- Investigators
- Bridget M Hron, MD, Principal investigator, Boston Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04900597
- Sponsor's protocol ID
- IRB-P00037093
- Status last verified
- Oct 2026
- First submitted
- 18 May 2021
- Last updated
- 22 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Blenderized Enteral Tube Feeds on Pediatric Upper Gastrointestinal Tract Physiology
- ClinicalTrials.gov ID
- NCT04900597
- Acronym / sponsor ID
- IRB-P00037093
- Conditions
- Enteral Feeding Intolerance
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Boston Children's HospitalUniversity, hospital or other
- Study start
- 1 Aug 2021 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 25 May 2021 (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.
Blenderized diets consist of a wide range of table foods such as fruits, vegetables, meat and legumes, pureed in a blender and administered via gastrostomy tube. In a recent study, the investigators reported that children receiving blenderized feeds via gastrostomy had fewer total admissions and respiratory admissions, total emergency room visits, and improved gastrointestinal symptom scores compared to those fed formula. The goal of this project is to understand how these diets affect gastroesophageal reflux burden.
Detailed description
The investigators hypothesize that rates of gastroesophageal reflux will be lower in blenderized diets compared to formula. The investigators will determine if reflux burden as measured by multichannel intraluminal impedance/esophageal pH monitoring performed for clinical purposes differs between low viscosity conventional formula, medium viscosity commercial blenderized diet, and high viscosity commercial blenderized diet in 45 children receiving conventional formula via gastrostomy. All participants will receive each of the three test diets in random order in a 3-way crossover design. Results of gastric emptying scans will be recorded if done for clinical purposes.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Elecare - Nourish - Real Foods Blends | Experimental | Other: Elecare Jr, Other: Nourish, Other: Real Foods BlendsElecare for first bolus, Nourish for second bolus, Real Foods Blends for third bolus |
| Nourish - Real Foods Blends - Elecare | Experimental | Other: Elecare Jr, Other: Nourish, Other: Real Foods BlendsNourish for first bolus, Real Foods Blends for second bolus, Elecare for first bolus |
| Real Foods Blends - Elecare - Nourish | Experimental | Other: Elecare Jr, Other: Nourish, Other: Real Foods BlendsReal Foods Blends for first bolus, Elecare for second bolus, Nourish for third bolus |
Who may qualify
- Ages
- 1 year and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Age 1-21 years
- G-tube
- Able to tolerate bolus gastric feeds over 30 minutes
- Use of conventional enteral formula
- Undergoing impedance study for clinical purposes
Key exclusion criteria (3 listed)
- History of allergy or intolerance to any component of the test diets
- History of Nissen fundoplication (participants with suspected or documented unwrapped fundoplication will be eligible for participation)
- Current use of non-invasive pressure support (continuous or bi-level positive airway pressure)
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 |
|---|---|---|
| Elecare JrElecare Jr is a standard pediatric elemental formula | Other | Elecare - Nourish - Real Foods Blends, Nourish - Real Foods Blends - Elecare, Real Foods Blends - Elecare - Nourish |
| NourishNourish is a commercially prepared blenderized tube feed that is formulated for pediatric use | Other | Elecare - Nourish - Real Foods Blends, Nourish - Real Foods Blends - Elecare, Real Foods Blends - Elecare - Nourish |
| Real Foods BlendsReal Foods Blends is a commercially prepared blenderized tube feed that is formulated for pediatric use | Other | Elecare - Nourish - Real Foods Blends, Nourish - Real Foods Blends - Elecare, Real Foods Blends - Elecare - Nourish |
Primary outcome
Reflux episodes
Time frame: 4 hours (following feed)
Number of total reflux episodes (acid and non-acid) by impedance
4 secondary outcomes
Full column reflux episodes
Time frame: 4 hours (following feed)
Percent of time esophageal pH < 4
Time frame: 4 hours after feed
Average height of refluxate
Time frame: 4 hours after feed
Number of symptoms
Time frame: 4 hours after feed
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 22 Oct 2026.
- Individual participant dataSharing planned: No
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Patients Who Receive Enteral Nutrition for at Least 72 Hours in the Intensive Care Unit Will be Included in the Study
Recruiting
Continuous Versus Intermittent Enteral Feeding and Gastric Residual Volume in Critically Ill Patients
Enteral Feeding Intolerance, Critical Illness
Not yet recruitingObservational study
Gut Microbiota Structure, Functional and Metabolic Profiles, and Composite Biomarkers in ICU Adults With Refractory Enteral Feeding Intolerance
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Transcutaneous Auricular Stimulation Targeting Enteral Feeding Intolerance
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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.
Bridget M Hron, MD principal investigator
Boston Children's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Elecare Jr, Nourish and Real Foods Blends in people with Enteral Feeding Intolerance, 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 5 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: looking for participants now, as of the sponsor's last update on 22 Oct 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.
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 Bridget M Hron, MD (6173556058, bridget.hron@childrens.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reflux episodes (time frame: 4 hours (following feed)). 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 22 Oct 2026.