Clinical Trial of Blenderized Tube Feeds Varying in Viscosity

Description

The investigators are conducting a 16 week multiple cross-over study (N-of-1 trial) comparing two blenderized tube feeds varying in viscosity in 40 children.

Conditions

Feeding Disorders

Talk to us

Study Overview

On this page

Study Details

Study overview

The investigators are conducting a 16 week multiple cross-over study (N-of-1 trial) comparing two blenderized tube feeds varying in viscosity in 40 children.

A Novel N-of-1 Randomized, Controlled, Clinical Trial to Assess the Effect of Blenderized Tube Feeds on Esophagogastric Physiology

Clinical Trial of Blenderized Tube Feeds Varying in Viscosity

Condition
Feeding Disorders
Intervention / Treatment

-

Contacts and Locations

Boston

Boston Children's Hospital, Boston, Massachusetts, United States, 02115

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * age \> 1 year
  • * \>90% of total calories via G-tube for \> 6 months
  • * G-tube diameter ≥ 14 French
  • * moderate severity of upper GI symptoms of nausea, bloating, postprandial fullness and early satiety defined as Gastroparesis Cardinal Symptom Index-Daily Diary (GCSI-DD) composite score \> 2
  • * anticipated stable GI-related medications for the duration of the study.
  • * cystic fibrosis, primary ciliary dyskinesia, interstitial lung disease, bronchiolitis obliterans, or lung transplant
  • * untreated malabsorptive intestinal disease (e.g. Crohn's disease, celiac disease)
  • * Nissen fundoplication
  • * use of non-standard enteral formulas (e.g. ketogenic formulas) for the management of metabolic, endocrine or neurologic rare diseases
  • * allergy or intolerance to any component of the study diet
  • * inability to tolerate bolus gastric feeds.

Ages Eligible for Study

1 Year to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Boston Children's Hospital,

Study Record Dates

2027-06-30