A Novel N-of-1 Randomized, Controlled, Clinical Trial to Assess the Effect of Blenderized Tube Feeds on Esophagogastric Physiology
Boston Children's Hospital
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
- Age range
- 1+ years
- Sex
- All
- Healthy volunteers
- No
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, cel…
Interventions
- OtherExtremely thick blenderized tube feed
Commercial blenderized tube feed, not diluted
- OtherMildly thick blenderized tube feed
Commercial blenderized tube feed, diluted with ingredients contained in blend
Location
- Boston Children's HospitalBoston, Massachusetts