High-Fiber Formula for Gut Health in Critically Ill Children

Overseen By Michael J Morowitz, MD

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: University of Pittsburgh

Must not be taking: Vasoactive medications

Disqualifiers: Allergies, Intolerances, Epilepsy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: 2 weeks

40 Participants Needed

What You Need to Know Before You Apply

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.

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.

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. ^{1 2 3 4 5}

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. ^{1 2 5 6 7}

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. ^{1 2 8 9 10}

Who Is on the Research Team?

Raj Aneja, MD

Principal Investigator

University of Pittsburgh Medical Center

Are You a Good Fit for This Trial?

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

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

Group I: Pediasure Active Control 1 Intervention

Patients assigned to this arm will receive Pediasure

Group II: Nourish Active Control 1 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

Who Is Running the Clinical Trial?

University of Pittsburgh

Lead Sponsor

Trials

1,820

Recruited

16,360,000+

Published Research Related to This Trial

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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]

The implementation of an enteral nutrition (EN) protocol in a pediatric intensive care unit (PICU) significantly improved the percentage of patients meeting their nutritional goals within the first 48 hours from 18% to 88%.

Following the introduction of clinical decision support tools and a standardized order set, the median time to start EN and reach goal nutrition decreased, and the length of stay in the PICU was reduced from 202 hours to 156 hours, indicating better nutritional management and improved patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical Decision Support Tools and a Standardized Order Set Enhances Early Enteral Nutrition in Critically Ill Children. Ziemba, KJ., Kumar, R., Nuss, K., et al.[2020]

Malnutrition in critically ill children, especially those with conditions like congenital heart disease or severe thermal injury, is linked to higher rates of complications and mortality in the pediatric intensive care unit (PICU).

Enteral nutrition (EN) is highlighted as a vital part of care that can improve outcomes for these patients, although challenges such as assessing nutrient needs and managing feeding interruptions complicate its delivery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Enteral Nutrition in the PICU: Current Status and Ongoing Challenges. Brown, AM., Carpenter, D., Keller, G., et al.[2020]

The study originally evaluated the efficacy of a tube feeding formula with real food ingredients, Compleat Pediatric 1.0, in pediatric patients with intestinal failure, but the formulation has since changed, potentially affecting the results.

The authors acknowledge that while their findings were based on the original formula, the new ingredients added by Nestlé Health Sciences may lead to different outcomes, highlighting the importance of product consistency in clinical research.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Notice of Changes to Compleat Pediatric 1.0. [2017]

In a pilot trial involving 58 Ugandan children with severe acute malnutrition, no significant differences were found in weight gain, mortality, or edema resolution among children receiving cowpea-based, inulin-based, or conventional feeds after 28 days, indicating similar efficacy across all feed types.

The study observed that legume-enriched feeds (cowpea) supported gut function and increased the abundance of beneficial gut bacteria (Bifidobacterium), suggesting potential benefits for gut health in malnourished children.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Modifying gut integrity and microbiome in children with severe acute malnutrition using legume-based feeds (MIMBLE): A pilot trial. Calder, N., Walsh, K., Olupot-Olupot, P., et al.[2022]

In a study of 70 critically ill infants in the pediatric intensive care unit (PICU), those who received protein and energy-enriched (PE) formulas for an average of 30 days showed a significant increase in weight-for-age Z-scores, indicating effective weight gain during their stay.

The PE-formula was well tolerated, with only a small percentage of infants experiencing gastrointestinal symptoms like diarrhea and vomiting, suggesting it is a safe nutritional intervention for this vulnerable population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Weight improvement with the use of protein and energy enriched nutritional formula in infants with a prolonged PICU stay. Eveleens, RD., Dungen, DK., Verbruggen, SCAT., et al.[2020]

A high-energy pediatric whey-based peptide formula has been shown to effectively manage symptoms in children with impaired gastrointestinal function, highlighting its potential as a nutritional intervention.

The use of this specialized formula in clinical practice addresses the complex nutritional needs of these children, suggesting it may improve their overall health and well-being.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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. Simpson, K.[2021]

Fiber-containing enteral formulas are recommended as first-line nutrition therapy for children requiring enteral nutrition, as they can improve bowel function and support healthy gut microbiota.

Dietary fibers should be introduced gradually, starting from six months of age, with careful consideration of individual tolerability and symptoms to optimize gastrointestinal health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of fiber-containing enteral formula in pediatric clinical practice: an expert opinion review. Lionetti, P., Wine, E., Ran Ressler, R., et al.[2023]

Citations

1. United States pubmed.ncbi.nlm.nih.gov

Safety and efficacy of a new pediatric enteral product in the young child. [2017]

2. Pakistan pubmed.ncbi.nlm.nih.gov

PediaSure in the treatment of severe malnutrition in Pakistani children. [2008]

3. Brazil pubmed.ncbi.nlm.nih.gov

Impact of early enteral nutrition therapy on morbimortality reduction in a pediatric intensive care unit: a systematic review. [2018]

4. United States pubmed.ncbi.nlm.nih.gov

Clinical Decision Support Tools and a Standardized Order Set Enhances Early Enteral Nutrition in Critically Ill Children. [2020]

5. Germany pubmed.ncbi.nlm.nih.gov

Enteral Nutrition in the PICU: Current Status and Ongoing Challenges. [2020]

6. United States pubmed.ncbi.nlm.nih.gov

Notice of Changes to Compleat Pediatric 1.0. [2017]

7. United States pubmed.ncbi.nlm.nih.gov

Modifying gut integrity and microbiome in children with severe acute malnutrition using legume-based feeds (MIMBLE): A pilot trial. [2022]

8. England pubmed.ncbi.nlm.nih.gov

Weight improvement with the use of protein and energy enriched nutritional formula in infants with a prolonged PICU stay. [2020]

9. England pubmed.ncbi.nlm.nih.gov

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]

10. England pubmed.ncbi.nlm.nih.gov

Use of fiber-containing enteral formula in pediatric clinical practice: an expert opinion review. [2023]