Clinical Trial of Blenderized Tube Feeds Varying in Viscosity
No applicable phase (e.g. observational)
Conditions:
Feeding Disorders
Sponsor: Boston Children's Hospital
trial.available_in:
БГ
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.
Who can participate
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.