Effects of high-fiber formulas on gut health in critically ill children
Influences of High-fiber, Organic Whole-food Formula on the Gut Microbiome in Critically Ill Children
This study tests if a high-fiber feeding formula can improve gut health in critically ill children aged 1-17 by changing their gut bacteria for the better.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 1 Year to 17 Years |
| Sex | All |
| Sponsor | University of Pittsburgh Academic / other |
| Locations | 1 site (Pittsburgh, Pennsylvania) |
| Trial ID | NCT03414775 on ClinicalTrials.gov |
What this trial studies
This study evaluates how two different enteral feeding formulas, Pediasure and Nourish, affect the gastrointestinal microbiome in critically ill children aged 1-17 years. Participants will be randomized to receive either formula while being monitored for changes in their microbiome profile. The study aims to determine if a high-fiber, organic formula can shift the microbiome towards a more favorable composition, potentially improving health outcomes. The research will analyze microbiome samples before and after the initiation of enteral feeding.
Who should consider this trial
Good fit: Ideal candidates are critically ill children aged 1-17 years who are stable enough for enteral tube feedings.
Not a fit: Patients with specific dietary needs or allergies to the formulas being tested may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved gut health and overall outcomes for critically ill pediatric patients.
How similar studies have performed: Previous studies have shown that dietary interventions can positively influence the microbiome, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Admitted to the pediatric intensive care unit * Age 1-17 years old * Previously placed enteric tube designed for enteric feeding Exclusion Criteria: * Vasoactive medication use * History of allergies or intolerances to either Pediasure or Nourish * Whey allergy or intolerance * Gluten sensitivity or intolerance * Medical condition that necessitate the use of specific formulas and/or nutritional needs (e.g. epilepsy requiring ketogenic diet, genetic metabolic dysfunction with specific formula requirements)
Where this trial is running
Pittsburgh, Pennsylvania
- Children's Hospital of Pittsburgh of UPMC — Pittsburgh, Pennsylvania, United States (Recruiting)
Study contacts
- Principal investigator: Raj Aneja, MD — University of Pittsburgh Medical Center
- Study coordinator: Justin Azar, MD
- Email: justin.azar@chp.edu
- Phone: 412-692-5833
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.