High-Fiber Formula for Gut Health in Critically Ill Children
Trial Summary
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. However, if you are using vasoactive medications, you cannot participate in the trial.
What data supports the effectiveness of the treatment Nourish, Functional Formularies Nourish, Nourish Organic Pediatric Meal Replacement, Pediasure, Pediasure, Nutritional Supplement for gut health in critically ill children?
Research shows that PediaSure, a component of the treatment, is effective in maintaining nutritional status and promoting growth in children who need specialized nutritional support. Additionally, early enteral nutrition (feeding through a tube) in critically ill children is linked to better health outcomes, suggesting that similar nutritional treatments could be beneficial.12345
Is the high-fiber formula safe for children?
How is the treatment Nourish, Pediasure different from other treatments for gut health in critically ill children?
Nourish and Pediasure are unique because they are high-fiber, nutrient-rich formulas designed to improve gut health and support growth in children who need specialized nutrition. These formulas not only meet nutritional needs but also promote healthy gut bacteria and improve bowel function, which is particularly beneficial for children with gastrointestinal issues.128910
What is the purpose of this trial?
This study evaluates the effects of either Pediasure or Nourish formulas on the gastrointestinal microbiome in critically-ill children. Patients will be randomized to received either Pediasure or Nourish.
Research Team
Raj Aneja, MD
Principal Investigator
University of Pittsburgh Medical Center
Eligibility Criteria
This trial is for critically ill children aged 1-17 who are in the pediatric intensive care unit and have a tube placed for feeding. It's not suitable for those on heart medications, with allergies to Pediasure or Nourish, whey/gluten sensitivities, or special dietary needs due to conditions like epilepsy.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive either Pediasure or Nourish formula via enteral tube feedings
Follow-up
Participants are monitored for changes in the gastrointestinal microbiome and concentration of short-chain fatty acids
Treatment Details
Interventions
- Nourish
- Pediasure
Nourish is already approved in United States, Canada for the following indications:
- Nutritional support for critically ill children
- Pediatric meal replacement
- Nutritional support for critically ill children
- Pediatric meal replacement
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Pittsburgh
Lead Sponsor