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Clinical Trial of Blenderized Tube Feeds Varying in Viscosity

Clinical Trial of Blenderized Tube Feeds Varying in Viscosity

Recruiting
1 years and older
All
Phase N/A

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Overview

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

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.

Study details
    Feeding Disorders

NCT05417958

Boston Children's Hospital

20 February 2024

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