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NCT05417958NARecruiting

Clinical Trial of Blenderized Tube Feeds Varying in Viscosity

Boston Children's Hospital

Start Date

10/12/2023

Completion Date

4/1/2028

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

Age Range: 1 years to No maximum

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.

Interventions

OTHER

Extremely thick blenderized tube feed

OTHER

Mildly thick blenderized tube feed

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Conditions

Feeding Disorders

Locations

Boston Children's Hospital

Boston, Massachusetts 02115

United States