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

NCT04900597 | Recruiting

• 1 other identifier: IRB-P00037093
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Enteral Feeding Intolerance

Outcome Measures

Primary Outcomes (1)

• Reflux episodes

  Number of total reflux episodes (acid and non-acid) by impedance

  4 hours (following feed)

Secondary Outcomes (4)

• Full column reflux episodes

  4 hours (following feed)

• Percent of time esophageal pH < 4

  4 hours after feed

• Average height of refluxate

  4 hours after feed

• Number of symptoms

  4 hours after feed

Other Outcomes (1)

• Gastric emptying (percent of ingested contents remaining in stomach at 1 hour)

  1 hour

Study Arms (3)

Elecare - Nourish - Real Foods Blends

EXPERIMENTAL

Elecare for first bolus, Nourish for second bolus, Real Foods Blends for third bolus

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

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

Other: Elecare Jr; Other: Nourish; Other: Real Foods Blends

Interventions

Nourish OTHER

Nourish is a commercially prepared blenderized tube feed that is formulated for pediatric use

Elecare - Nourish - Real Foods Blends; Nourish - Real Foods Blends - Elecare; Real Foods Blends - Elecare - Nourish

Real Foods Blends OTHER

Real Foods Blends is a commercially prepared blenderized tube feed that is formulated for pediatric use

Elecare - Nourish - Real Foods Blends; Nourish - Real Foods Blends - Elecare; Real Foods Blends - Elecare - Nourish

Elecare Jr OTHER

Elecare Jr is a standard pediatric elemental formula

Elecare - Nourish - Real Foods Blends; Nourish - Real Foods Blends - Elecare; Real Foods Blends - Elecare - Nourish

Eligibility Criteria

• Age: 1 Year+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Boston Children's Hospital: lead

Study Sites (1)

Boston Children's Hospital

Boston, Massachusetts, 02115, United States

RECRUITING

Study Officials

• Bridget M Hron, MD

  Boston Children's Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Bridget M Hron, MD

CONTACT

6173556058; bridget.hron@childrens.harvard.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Staff Physician

Study Record Dates

• First Submitted: May 18, 2021
• First Posted: May 25, 2021
• Study Start: August 1, 2021
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: March 30, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)