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Clinical Trial of Blenderized Tube Feeds Varying in Viscosity
Recruiting
A Novel N-of-1 Randomized, Controlled, Clinical Trial to Assess the Effect of Blenderized Tube Feeds on Esophagogastric Physiology
Who can join
Ages 1 and older · All sexes
Full eligibility criteria
Inclusion 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. Exclusion Criteria: * 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.
About the study
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.
What is being tested
- Extremely thick blenderized tube feed (other)
- Mildly thick blenderized tube feed (other)
Sponsor: Boston Children's Hospital · Participants: 40 · Started: Oct 12, 2023
Contact the study team
Official record on ClinicalTrials.gov — NCT05417958
Locations in the U.S.
| Massachusetts | Boston Children's Hospital, Boston |
Conditions
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.