NCT05417958NARecruiting
Clinical Trial of Blenderized Tube Feeds Varying in Viscosity
Boston Children's Hospital
Start Date
10/12/2023
Completion Date
4/1/2028
Summary
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.
Eligibility Criteria
Age Range: 1 years to No maximum
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.
Interventions
OTHER
Extremely thick blenderized tube feed
OTHER
Mildly thick blenderized tube feed
Conditions
Feeding Disorders
Locations
Boston Children's Hospital
Boston, Massachusetts 02115
United States