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 trial explores how two nutritional formulas, Pediasure and Nourish (also known as Functional Formularies Nourish or Nourish Organic Pediatric Meal Replacement), impact gut health in seriously ill children. Researchers aim to determine which formula better supports the digestive system in these young patients. Children admitted to the pediatric intensive care unit and already receiving tube feeding may qualify for this study. As an unphased trial, this study provides a unique opportunity to contribute to important research on enhancing nutritional support for seriously ill children.

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 there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that both Nourish and Pediasure are safe for children. Nourish, a plant-based, organic formula, serves as both a feeding tube option and a meal replacement. It excludes common allergens like gluten, dairy, and soy, which helps many children tolerate it well. The available data has not reported any specific safety concerns for Nourish.

Pediasure has also been proven safe for supporting children's nutrition and growth. Studies have demonstrated its effectiveness without significant side effects. Both formulas are designed to provide essential nutrition for seriously ill children, and research has not identified any major safety issues with either product. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Unlike the standard nutritional support options for critically ill children, which often focus on basic calorie and protein provision, Nourish and Pediasure stand out because they emphasize gut health through high-fiber content. Nourish is unique because it combines a blend of fibers specifically designed to support the digestive system, potentially reducing inflammation and promoting better nutrient absorption. Pediasure, on the other hand, is well-known for its balanced nutritional profile tailored for children, but in this trial, it's being explored for its potential benefits in a high-fiber formulation. Researchers are excited about these treatments because improving gut health could lead to faster recovery times and better overall outcomes for critically ill children.

What evidence suggests that this trial's treatments could be effective for gut health in critically ill children?

Research shows that Nourish, a treatment in this trial, is a plant-based, organic formula made from whole foods to support gut health. Rich in antioxidants, it can aid digestion. The formula contains no common allergens or additives, making it gentler on sensitive stomachs.

Another treatment option in this trial is Pediasure. Studies have shown that it can improve nutrition and health in undernourished children. It provides a balanced mix of nutrients that may help maintain or improve weight and overall health.

Both formulas in this trial aim to support the gut microbiome, which is crucial for digestion and nutrient absorption. While direct data comparing their effects in critically ill children is limited, each formula contains ingredients generally beneficial for gut health and nutrition. ^{2 6 7 8 9}

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

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]

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]

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]

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]

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]

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]

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]

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]

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]

Citations

1. functionalformularies.com functionalformularies.com/product/nourish/?srsltid=AfmBOoohVv5iqazTvEaFD1AMLyN_OWAmR1BknEaao1V_tx-lfrhv6syc

Nourish - Organic Feeding Tube Formula for Kids Nourish is a plant-based, organic, whole food, shelf-stable feeding tube formula and oral meal replacement for children, designed to maintain healthy weight.

2. amazon.com amazon.com/Functional-Formularies-Nourish-12oz-Pouch/dp/B07PH1SPCD

Functional Formularies Nourish Organic Tube Feeding ... Nourish is a shelf-stable, organic, whole food, 400 calorie, plant-based, GMO-free, gluten-free, dairy-free, soy-free, and corn-free tube feeding formula for ...

3. carewell.com carewell.com/product/functional-formularies-nourish-peptide-organic-pediatric-meal-replacement/?sku=NOUPBWS124-CS24&srsltid=AfmBOortWl0DFNENKJKHkKtJ4FPV6IOB5blvbigUEJz--8J9s7NUNBla

Functional Formularies Nourish Peptide Organic Pediatric ... This organic, whole food, plant-based peptide formula is packed with berry antioxidants and functional ingredients for optimal digestion and gut health.

4. functionalformularies.com functionalformularies.com/wp-content/uploads/2025/02/nourish-long-nutritionals-N-021sp.pdf?srsltid=AfmBOorEHMTXEUWSo5EnJ3vCROU7rB-oLD6mJoD1-1Q8UKF_fIx1bCSY

Nourish | Functional Formularies Nourish is an organic, shelf-stable, whole food meal replacement for children 4-8, designed for tube or oral feeding, and is free of tree nuts, gluten, dairy, ...

5. medexsupply.com medexsupply.com/functional-formularies-nourish-pediatric-formula-or-oral-meal-replacement-each/?srsltid=AfmBOoomYIChT7kUSPsdHAgG-HwVGsdkIqCoNHjdX4louaPiyRuINnz7

Functional Formularies Nourish Pediatric Formula or Oral ... USDA certified organic · Whole food ingredients · Free of added sugars (corn syrup solids, fruit juice concentrates, brown rice syrup) · Free of the top 8 food ...

6. functionalformularies.com functionalformularies.com/product/nourish/?srsltid=AfmBOooPqXmYGI9z3WBX82zGdzTPnFcYCpHtXFGbbKVHRNsKL2VHgnSS

Nourish - Organic Feeding Tube Formula for Kids Nourish is a plant-based, organic, whole food, shelf-stable feeding tube formula and oral meal replacement for children, designed to maintain healthy weight.

7. carewell.com carewell.com/product/functional-formularies-nourish-organic-pediatric-meal-replacement/?sku=NWS124-EA1&srsltid=AfmBOor_XuAesgcGq2lPe7JTchoaO3iDW7zynC7719ftpjBx33GxldTR

Functional Formularies Nourish Organic Pediatric Meal ... USDA certified organic; Whole food ingredients; Free of added sugars (corn syrup solids, fruit juice concentrates, brown rice syrup); Free of the top 8 food ...

8. medexsupply.com medexsupply.com/functional-formularies-nourish-pediatric-formula-or-oral-meal-replacement-each/?srsltid=AfmBOoo_ItvPBQJ9_bW1bUodzITKRhS6IvoAyvJKby0IlBgCTBDtoy-9

Functional Formularies Nourish Pediatric Formula or Oral ... USDA certified organic · Whole food ingredients · Free of added sugars (corn syrup solids, fruit juice concentrates, brown rice syrup) · Free of the top 8 food ...

9. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40112919/

High-density enteral formula in critically ill pediatric patients This study aimed to assess efficacy and safety of energy or protein-dense enteral formula through a systematic review and meta-analysis.