RecruitingNot ApplicableNCT05417958
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
Sponsor
Boston Children's Hospital
Enrollment
40 participants
Start Date
Oct 12, 2023
Study Type
INTERVENTIONAL
Conditions
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
Min Age: 1 Year
Inclusion Criteria5
- 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 Criteria6
- 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.
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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
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT05417958