Clinical Trial of Blenderized Tube Feeds Varying in Viscosity
Feeding Disorders
About this trial
This is an interventional treatment trial for Feeding Disorders
Eligibility Criteria
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Experimental
Experimental
Experimental
Experimental
Extremely Thick - Mildly Thick - Extremely Thick - Mildly Thick
Extremely Thick - Mildly Thick - Mildly Thick - Extremely Thick
Mildly Thick - Extremely Thick - Extremely Thick - Mildly Thick
Mildly Thick - Extremely Thick - Mildly Thick - Extremely Thick
Participants will receive 4 weeks Extremely Thick, 4 weeks Mildly Thick, 4 weeks Extremely Thick and 4 weeks Mildly Thick blenderized tube feeds. The volume, caloric density and frequency will be matched to pre-study feeding regimen.
Participants will receive 4 weeks Extremely Thick, 4 weeks Mildly Thick, 4 weeks Mildly Thick and 4 weeks Extremely Thick blenderized tube feeds. The volume, caloric density and frequency will be matched to pre-study feeding regimen.
Participants will receive 4 weeks Mildly Thick, 4 weeks Extremely Thick, 4 weeks Extremely Thick and 4 weeks Mildly Thick blenderized tube feeds. The volume, caloric density and frequency will be matched to pre-study feeding regimen.
Participants will receive 4 weeks Mildly Thick, 4 weeks Extremely Thick, 4 weeks Mildly Thick and 4 weeks Extremely Thick blenderized tube feeds. The volume, caloric density and frequency will be matched to pre-study feeding regimen.