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NCT Number: NCT04900597

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.

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Key information

Conditions

Enteral Feeding Intolerance

Age range

1 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Boston Children's Hospital

Boston, Massachusetts, 02115, United States

Location status: Recruiting

Location contact

Bridget M Hron, MD

CONTACT

[email protected]

6173551433

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Elecare Jr

Other

Elecare Jr is a standard pediatric elemental formula

Nourish

Other

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

Real Foods Blends

Other

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

Primary outcomes

  1. Reflux episodes

    Time frame: 4 hours (following feed)

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

Secondary outcomes

  1. Full column reflux episodes

    Time frame: 4 hours (following feed)

    Total number of full-column reflux episodes by impedance

  2. Percent of time esophageal pH < 4

    Time frame: 4 hours after feed

    Percent of time esophageal pH < 4 by impedance

  3. Average height of refluxate

    Time frame: 4 hours after feed

    Average height of refluxate by impedance

  4. Number of symptoms

    Time frame: 4 hours after feed

    Frequency of pulmonary and gastrointestinal symptoms from questionnaires during impedance

Other outcomes

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

    Time frame: 1 hour

    Gastric emptying scans by scintigraphy will be analyzed if performed for clinical reasons

Study contacts

Contact information is provided by the study sponsor or research team.

Bridget M Hron, MD

CONTACT

[email protected]

6173556058

Sponsors and collaborators

Lead sponsor

Boston Children's Hospital

Other

Registry information

Important dates

Study start
2021
Primary completion
2026
Study completion
2026
First posted
May 25, 2021
Registry last updated
Mar 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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