Effect of Thickened Blenderized Tube Feeds on Upper Gastrointestinal Symptoms in Children with Feeding Disorders A 16-Week N-of-1 Randomized Clinical Trial Comparing Extremely Thick and Mildly Thick Feeds

What this Trial Is About

Researchers are conducting a 16-week multiple cross-over clinical trial to study feeding disorders in children. The trial compares two types of blenderized tube feeds that differ in thickness or viscosity. This study aims to assess how these feeds affect esophagogastric physiology and related symptoms in children who receive most of their nutrition through a gastrostomy tube. Participants will receive alternating 4-week periods of either extremely thick or mildly thick blenderized tube feeds. The feeds are commercial blends, with the mildly thick version diluted using ingredients already present in the blend. The volume, caloric density, and feeding frequency will be matched to each childs pre-study regimen. There are four different feeding sequences in this randomized trial, each alternating these two feed types. During the study, children will be monitored for upper gastrointestinal symptoms, general gastrointestinal and pulmonary symptoms, healthcare use, medication use, growth measures such as height and weight, respiratory needs, and other health indicators. Researchers will compare the effects of 8 weeks on extremely thick versus 8 weeks on mildly thick feeds using symptom diaries and clinical assessments. The total participation lasts 16 weeks, with regular monitoring of symptoms and healthcare events throughout that time.

Clinical Trial of Blenderized Tube Feeds Varying in Viscosity