40 Participants Needed

High-Fiber Formula for Gut Health in Critically Ill Children

JA
MJ
Overseen ByMichael J Morowitz, MD
Age: < 18
Sex: Any
Trial Phase: Academic
Sponsor: University of Pittsburgh
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

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?

Research on PediaSure, a similar nutritional product, shows it is safe for children, as it was well-tolerated and supported growth without significant side effects in studies.12678

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

RA

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

I am between 1 and 17 years old.
My child is currently in the pediatric intensive care unit.
Previously placed enteric tube designed for enteric feeding

Exclusion Criteria

I am taking medication to control my blood pressure.
History of allergies or intolerances to either Pediasure or Nourish
Whey allergy or intolerance
See 2 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive either Pediasure or Nourish formula via enteral tube feedings

2 weeks
Visits on day 1, day 5-7, and day 14

Follow-up

Participants are monitored for changes in the gastrointestinal microbiome and concentration of short-chain fatty acids

2 weeks

Treatment Details

Interventions

  • Nourish
  • Pediasure
Trial Overview The study compares the effects of two different formulas—Pediasure and Nourish—on the gut bacteria of sick kids. Children will be randomly assigned to receive one of these formulas through their feeding tubes.
Participant Groups
2Treatment groups
Active Control
Group I: PediasureActive Control1 Intervention
Patients assigned to this arm will receive Pediasure
Group II: NourishActive Control1 Intervention
Patients assigned to this arm will receive Nourish

Nourish is already approved in United States, Canada for the following indications:

🇺🇸
Approved in United States as Nourish for:
  • Nutritional support for critically ill children
  • Pediatric meal replacement
🇨🇦
Approved in Canada as Nourish for:
  • 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

Trials
1,820
Recruited
16,360,000+

Findings from Research

A study involving 14 chronically disabled children showed that PediaSure, a new pediatric enteral product, effectively met their nutritional needs over a 12-week period, leading to significant improvements in growth measurements such as weight and length.
The product was well-tolerated with excellent gastrointestinal acceptance, and there were no clinically significant adverse effects, indicating that PediaSure is both safe and effective for maintaining nutritional status in young children requiring specialized support.
Safety and efficacy of a new pediatric enteral product in the young child.Ramstack, M., Listernick, R.[2017]
In a study of 31 severely malnourished children aged 1-5 years, using 'PediaSure' for 2 weeks resulted in a significant increase in caloric intake and an average weight gain of 7.5 gm/kg/day, indicating its efficacy in nutritional rehabilitation.
The use of 'PediaSure' was well-tolerated with no reported cases of diarrhea or significant chemical imbalances, suggesting it is a safe option for initial nutrition therapy in malnourished children.
PediaSure in the treatment of severe malnutrition in Pakistani children.Akram, DS., Bharmal, FY., Hussain, T.[2008]
Malnutrition affects 15-30% of hospitalized children in pediatric intensive care units, and despite improvements in clinical care, its prevalence has not changed in the last 20 years, highlighting the need for better recognition and treatment.
Current evidence supporting the use of enteral nutrition therapy to reduce morbidity and mortality in critically ill pediatric patients is limited, with most guidelines based on expert opinion rather than robust randomized controlled trials, indicating a need for further research in this area.
Impact of early enteral nutrition therapy on morbimortality reduction in a pediatric intensive care unit: a systematic review.Silva, FM., Bermudes, AC., Maneschy, IR., et al.[2018]

References

Safety and efficacy of a new pediatric enteral product in the young child. [2017]
PediaSure in the treatment of severe malnutrition in Pakistani children. [2008]
Impact of early enteral nutrition therapy on morbimortality reduction in a pediatric intensive care unit: a systematic review. [2018]
Clinical Decision Support Tools and a Standardized Order Set Enhances Early Enteral Nutrition in Critically Ill Children. [2020]
Enteral Nutrition in the PICU: Current Status and Ongoing Challenges. [2020]
Notice of Changes to Compleat Pediatric 1.0. [2017]
Modifying gut integrity and microbiome in children with severe acute malnutrition using legume-based feeds (MIMBLE): A pilot trial. [2022]
Weight improvement with the use of protein and energy enriched nutritional formula in infants with a prolonged PICU stay. [2020]
Clinical Case Reports on the acceptability and tolerance of a High-Energy whey peptide-based Pediatric oral nutritional supplement in children aged over 12 months. [2021]
Use of fiber-containing enteral formula in pediatric clinical practice: an expert opinion review. [2023]
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