RECRUITINGINTERVENTIONAL
Clinical Trial of Blenderized Tube Feeds Varying in Viscosity
A Novel N-of-1 Randomized, Controlled, Clinical Trial to Assess the Effect of Blenderized Tube Feeds on Esophagogastric Physiology
About This Trial
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 May Be Eligible (Plain English)
Who May Qualify:
- 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.
Who Should NOT Join This Trial:
- 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.
Always talk to your doctor about whether this trial is right for you.
Original Eligibility Criteria
View original clinical language
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.
Treatments Being Tested
OTHER
Extremely thick blenderized tube feed
Commercial blenderized tube feed, not diluted
OTHER
Mildly thick blenderized tube feed
Commercial blenderized tube feed, diluted with ingredients contained in blend
Locations (1)
Boston Children's Hospital
Boston, Massachusetts, United States