NCT04900597

Effect of Blenderized Enteral Tube Feeds on Pediatric Upper Gastrointestinal Tract Physiology

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 45 (estimated)
• Sponsor: Boston Children's Hospital · Academic / Other
• Sex: All
• Age: 1 Year
• Healthy volunteers: Not accepted

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 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.

Conditions

• Enteral Feeding Intolerance

Interventions

Type	Name	Description
OTHER	Elecare Jr	Elecare Jr is a standard pediatric elemental formula
OTHER	Nourish	Nourish is a commercially prepared blenderized tube feed that is formulated for pediatric use
OTHER	Real Foods Blends	Real Foods Blends is a commercially prepared blenderized tube feed that is formulated for pediatric use

Timeline

• Start date: 2021-08-01
• Primary completion: 2026-07-01
• Completion: 2026-12-01
• First posted: 2021-05-25
• Last updated: 2026-03-30

Locations

1 site across 1 country: United States