Actively Recruiting
Effect of Blenderized Enteral Tube Feeds on Pediatric Upper Gastrointestinal Tract Physiology
Led by Boston Children's Hospital · Updated on 2026-03-30
45
Participants Needed
1
Research Sites
21 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying the effects of blenderized diets on children with enteral feeding intolerance who receive nutrition through gastrostomy tubes. The study aims to compare how blenderized tube feeds versus conventional formula affect gastroesophageal reflux in children aged 1 to 21 years. This research is designed as an interventional trial using a randomized crossover approach to better understand reflux burden with different feeding types. Participants will receive three types of test diets in random order: Elecare Jr, a standard pediatric elemental formula with low viscosity; Nourish, a medium viscosity commercially prepared blenderized tube feed; and Real Foods Blends, a high viscosity commercially prepared blenderized tube feed. Each child will receive these diets as bolus feeds, and the order of administration varies across three groups in a 3-way crossover design. During the study, reflux will be measured using multichannel intraluminal impedance and esophageal pH monitoring over four hours following each feed. Researchers will record the number and characteristics of reflux episodes, including full column reflux episodes, percentage of time with esophageal pH below 4, refluxate height, and related symptoms. Gastric emptying scans will also be reviewed if performed clinically. The total participation involves undergoing these monitoring procedures and dietary interventions under clinical observation.
CONDITIONS
Brief Title
Effect of Blenderized Enteral Tube Feeds on Pediatric Upper Gastrointestinal Tract Physiology
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 1 to 21 years
- Presence of a gastrostomy tube (G-tube)
- Able to tolerate bolus gastric feeds over 30 minutes
- Currently using conventional enteral formula
- Undergoing impedance study for clinical purposes
You will not qualify if you...
- Allergy or intolerance to any component of the test diets
- History of Nissen fundoplication surgery (except suspected or unwrapped cases)
- Current use of non-invasive pressure support such as continuous or bi-level positive airway pressure
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Duration of crossover feeding with three test diets
Participants receive multichannel intraluminal impedance/esophageal pH monitoring while receiving each of the three test diets in random order to measure gastroesophageal reflux.
3 feeding visits with monitoring (in-person)
Trial Site Locations
Total: 1 location
1
Boston Children's Hospital
Boston, Massachusetts, United States, 02115
Actively Recruiting
Research Team
B
Bridget M Hron, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
DIAGNOSTIC
Number of Arms
3
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