Comparing thick and mildly thick blenderized tube feeds for children
Official title: A Novel N-of-1 Randomized, Controlled, Clinical Trial to Assess the Effect of Blenderized Tube Feeds on Esophagogastric Physiology
Run by Boston Children's Hospital · NCT05417958 · Data updated 2026-11-12
This study is testing whether thicker or mildly thick blenderized tube feeds work better for kids with G-tubes who have stomach issues.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 1 Year and up |
| Sex | All |
| Enrollment | 40 (estimated) |
| Sponsor | Boston Children's Hospital Academic / other |
| Locations | 1 site (Boston, Massachusetts) |
| Status | Recruiting |
| Started | October 12, 2023 |
| Main results expected | October 1, 2027 |
| Study ends | April 1, 2028 |
| Registry record updated | April 17, 2026 |
| Trial ID | NCT05417958 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are children over one year old who have been dependent on G-tube feeding for more than six months and experience moderate gastrointestinal symptoms.
✕Probably not a fit
Patients with specific gastrointestinal diseases or conditions, such as cystic fibrosis or untreated malabsorptive intestinal diseases, may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This clinical trial is a 16-week multiple cross-over study designed to compare the effects of two types of blenderized tube feeds with varying viscosities in children who rely on G-tube feeding. The study will involve 40 participants who have been using G-tube feeding for over six months and experience moderate upper gastrointestinal symptoms. Each child will receive both types of feeds in a randomized order to assess their tolerance and symptom relief. The primary goal is to determine which viscosity of tube feed is better tolerated and more effective in alleviating feeding-related symptoms.
Why it matters
Potential benefit: If successful, this study could lead to improved feeding strategies for children with feeding disorders, enhancing their nutritional intake and quality of life.
How similar studies have gone: While there may be limited studies specifically comparing viscosities of blenderized tube feeds, the approach of using N-of-1 trials has shown promise in personalized medicine, suggesting potential for success.
Who can join: the full rules
Show full inclusion / exclusion 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.
Where it's running
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Boston Children's Hospital
Boston, Massachusetts, United States Recruiting
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.