Recruiting

Blenderized Diets

Sponsor:

Boston Children's Hospital

Code:

NCT04900597

Conditions

Enteral Feeding Intolerance

Eligibility Criteria

Sex: All

Age: 1+

Healthy Volunteers: Not accepted

Interventions

Elecare Jr

Nourish

Real Foods Blends

Study Details

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

Study ID

NCT04900597

Start date

Aug 1, 2021

Status verified date

Mar, 2026

Completion date

Dec, 2026

Anticipated

Primary completion date

Jul, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 1+

Healthy Volunteers: Not accepted

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 Design

Enrollment

45 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

experimental: Elecare - Nourish - Real Foods Blends

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

experimental: Nourish - Real Foods Blends - Elecare

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

experimental: Real Foods Blends - Elecare - Nourish

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

Interventions

Elecare Jr

Elecare Jr is a standard pediatric elemental formula

Nourish

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

Real Foods Blends

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

Primary outcome measure

  • Reflux episodes [ Time Frame: 4 hours (following feed) ]

Central Contacts and Locations

Central contacts

Bridget M Hron, MD

6173556058bridget.hron@childrens.harvard.edu

Locations

Boston Children's Hospital

Recruiting

Boston, Massachusetts, United States, 02115

Contacts

Bridget M Hron, MD

6173551433bridget.hron@childrens.harvard.edu

More Information

Sponsor

Boston Children's Hospital

Last update posted

Mar 30, 2026

Last verified

Mar, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Boston Children's Hospital on 2026-03-30.