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

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.

Study Overview

• Status: Recruiting
• Conditions: Enteral Feeding Intolerance
• Intervention / Treatment: Other: Elecare Jr; Other: Nourish; Other: Real Foods Blends

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 Type: Interventional
• Enrollment (Estimated): 45
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Bridget M Hron, MD; Phone Number: 6173556058; Email: bridget.hron@childrens.harvard.edu

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Recruiting
      • Boston Children's Hospital
      • Contact: Bridget M Hron, MD; Phone Number: 6173551433; Email: bridget.hron@childrens.harvard.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 21 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Elecare - Nourish - Real Foods Blends; Elecare for first bolus, Nourish for second bolus, Real Foods Blends for third bolus	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
Experimental: Nourish - Real Foods Blends - Elecare; Nourish for first bolus, Real Foods Blends for second bolus, Elecare for first bolus	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
Experimental: Real Foods Blends - Elecare - Nourish; Real Foods Blends for first bolus, Elecare for second bolus, Nourish for third bolus	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Reflux episodes	Number of total reflux episodes (acid and non-acid) by impedance	4 hours (following feed)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Full column reflux episodes	Total number of full-column reflux episodes by impedance	4 hours (following feed)
Percent of time esophageal pH < 4	Percent of time esophageal pH < 4 by impedance	4 hours after feed
Average height of refluxate	Average height of refluxate by impedance	4 hours after feed
Number of symptoms	Frequency of pulmonary and gastrointestinal symptoms from questionnaires during impedance	4 hours after feed

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Gastric emptying (percent of ingested contents remaining in stomach at 1 hour)	Gastric emptying scans by scintigraphy will be analyzed if performed for clinical reasons	1 hour

Collaborators and Investigators

• Sponsor: Boston Children's Hospital
• Investigators: Principal Investigator: Bridget M Hron, MD, Boston Children's Hospital

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2021
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: May 18, 2021
• First Submitted That Met QC Criteria: May 21, 2021
• First Posted (Actual): May 25, 2021

Study Record Updates

• Last Update Posted (Actual): March 30, 2026
• Last Update Submitted That Met QC Criteria: March 25, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: IRB-P00037093

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No