Clinical Trial of Blenderized Tube Feeds Varying in Viscosity (NCT05417958) | Clinical Trial Compass
RecruitingNot Applicable
Clinical Trial of Blenderized Tube Feeds Varying in Viscosity
United States40 participantsStarted 2023-10-12
Plain-language 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.
Who can participate
Age range1 Year
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* age \> 1 year
* \>90% of total calories via G-tube for \> 6 months
* G-tube diameter ā„ 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.
What they're measuring
1
Upper GI symptoms
Timeframe: 8 weeks of extremely vs. 8 weeks of mildly thick blends (multiple cross-over design)