Actively Recruiting
A Novel N-of-1 Randomized, Controlled Clinical Trial to Assess the Effect of Blenderized Tube Feeds on Esophagogastric Physiology
Led by Boston Children's Hospital · Updated on 2026-04-17
40
Participants Needed
1
Research Sites
26 weeks
Total Duration
On this page
AI-Summary
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 child's 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.
CONDITIONS
Brief Title
Clinical Trial of Blenderized Tube Feeds Varying in Viscosity
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age greater than 1 year
- Receiving more than 90% of total calories via gastrostomy tube for more than 6 months
- Gastrostomy tube diameter at least 14 French
- Moderate upper gastrointestinal symptoms (nausea, bloating, fullness) with a symptom score over 2
- Stable gastrointestinal-related medications expected during the study period
You will not qualify if you...
- Diagnosis of cystic fibrosis, primary ciliary dyskinesia, interstitial lung disease, bronchiolitis obliterans, or lung transplant
- Untreated malabsorptive intestinal diseases such as Crohn's disease or celiac disease
- History of Nissen fundoplication surgery
- Use of non-standard enteral formulas like ketogenic diets for rare metabolic, endocrine, or neurologic diseases
- Allergy or intolerance to any components of the study diet
- Inability to tolerate bolus gastric feeds
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 16 weeks
Participants receive alternating 4-week periods of extremely thick and mildly thick blenderized tube feeds. The volume, caloric density, and frequency of feeds are matched to the participant's pre-study feeding regimen.
Regular visits to monitor symptoms and health outcomes during feeding periods
Trial Site Locations
Total: 1 location
1
Boston Children's Hospital
Boston, Massachusetts, United States, 02115
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
TREATMENT
Number of Arms
4
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