Blenderized diets for children with feeding intolerance
Official title: Effect of Blenderized Enteral Tube Feeds on Pediatric Upper Gastrointestinal Tract Physiology
Run by Boston Children's Hospital · NCT04900597 · Data updated 2026-11-12
This study tests whether different types of blended diets can help children with feeding intolerance by seeing how they affect reflux symptoms.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 1 Year and up |
| Sex | All |
| Enrollment | 45 (estimated) |
| Sponsor | Boston Children's Hospital Academic / other |
| Locations | 1 site (Boston, Massachusetts) |
| Status | Recruiting |
| Started | August 1, 2021 |
| Main results expected | December 2027 |
| Study ends | December 2028 |
| Registry record updated | October 22, 2026 |
| Trial ID | NCT04900597 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are children aged 1-21 years with a gastrostomy tube who can tolerate bolus gastric feeds and are currently using conventional enteral formula.
✕Probably not a fit
Patients with a history of allergy or intolerance to any components of the test diets or those who have undergone Nissen fundoplication may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study investigates the effects of blenderized enteral tube feeds on pediatric patients experiencing feeding intolerance. It aims to compare the rates of gastroesophageal reflux among children receiving different types of diets: low viscosity conventional formula, medium viscosity commercial blenderized diet, and high viscosity commercial blenderized diet. Participants will be randomly assigned to receive each diet in a crossover design, allowing for direct comparison of reflux burden as measured by specialized monitoring techniques. The study also records gastric emptying scans when clinically indicated.
Why it matters
Potential benefit: If successful, this study could lead to improved dietary options for children with feeding intolerance, potentially reducing reflux symptoms and hospital visits.
How similar studies have gone: Previous studies have shown promising results with blenderized diets in reducing hospital admissions and improving gastrointestinal symptoms, suggesting a potential for success in this approach.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Exclusion Criteria: * 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)
Where it's running
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Boston Children's Hospital
Boston, Massachusetts, United States Recruiting
Study contacts
- Principal investigator: Bridget M Hron, MD — Boston Children's Hospital
- Study coordinator: Bridget M Hron, MD
- Email: bridget.hron@childrens.harvard.edu
- Phone: 6173556058
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Continuous vs. Intermittent Enteral Feeding in Critically Ill Adults
This study tests whether continuous or intermittent gastric feeding leads to different amounts of remaining stomach contents in critically ill adults.
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Bedside ultrasound measurement of the stomach antral area to predict enteral feeding intolerance
This test uses an early bedside ultrasound of the stomach's antral area to see if it can predict which ventilated adult patients on tube feeding will later have poor gastric tolerance.
-
Semi-elemental tube feeding to improve gut tolerance after severe traumatic brain injury
This will test whether starting semi-elemental tube feeding within 48 hours reduces gastrointestinal intolerance in adults with severe traumatic brain injury.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.