Status:
RECRUITING
Clinical Trial of Blenderized Tube Feeds Varying in Viscosity
Lead Sponsor:
Boston Children's Hospital
Conditions:
Feeding Disorders
Eligibility:
All Genders
1+ years
Phase:
NA
Brief 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
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 12 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 30 2027
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT05417958
Start Date
October 12 2023
End Date
June 30 2027
Last Update
April 2 2025
Active Locations (1)
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1
Boston Children's Hospital
Boston, Massachusetts, United States, 02115