Enfamil NeuroPro for Infant Gut Health

Overseen By Fayez Ghishan, MD

Age: < 18

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: University of Arizona

No Placebo Group

Trial Summary

What is the purpose of this trial?

This trial compares two types of baby formulas and breast milk in infants over a few months. It aims to see if adding specific ingredients to formula can make the gut bacteria similar to that of breastfed babies.

Do I have to stop my baby's current medications for the trial?

The protocol does not specify if you need to stop your baby's current medications, but you must avoid giving prebiotics, probiotics, symbiotics, and immune-stimulating products to your child during the study.

What data supports the idea that Enfamil NeuroPro for Infant Gut Health is an effective treatment?

The available research shows that a partially hydrolyzed formula with low lactose and probiotics, similar to Enfamil NeuroPro, can help improve mild gastrointestinal disorders in infants. In a study, infants fed this type of formula showed a significant decrease in gastrointestinal symptoms over 14 days, with scores dropping from 36.0 to 26.5, indicating less discomfort. Additionally, the prevalence of digestive distress decreased from 87.5% to 28.8%. Another study found that a similar formula improved symptoms like fussiness, gas, and crying within just one day, and these improvements lasted throughout the study. This suggests that Enfamil NeuroPro could be effective in reducing gastrointestinal issues in infants. ^{1 2 3 4 5}

What safety data exists for Enfamil NeuroPro for Infant Gut Health?

The provided research does not directly address the safety data for Enfamil NeuroPro or its variants. However, it discusses general safety and efficacy aspects of infant formulae, including partially hydrolyzed formulas with probiotics, which may be relevant to Enfamil NeuroPro's formulation. The studies indicate that infant formulas are generally well-tolerated, with some showing benefits for gastrointestinal health and neurodevelopment. No specific adverse events were reported in the studies, suggesting a favorable safety profile for similar types of infant formulas. ^{1 5 6 7 8}

Is Enfamil NeuroPro a promising treatment for infant gut health?

Yes, Enfamil NeuroPro is a promising treatment for infant gut health. It contains ingredients like partially hydrolyzed protein and probiotics, which have been shown to improve gastrointestinal symptoms in infants. These components can help reduce digestive issues like vomiting and flatulence, and support healthy gut development, which is important for overall health and development. ^{1 8 9 10 11}

Eligibility Criteria

This trial is for healthy, full-term infants with parents who consent to participate. Parents must be able to give informed consent, own a smartphone, and complete weekly digital questionnaires. Infants born prematurely or via c-section, those with health issues at postpartum screening, or receiving prebiotics/probiotics/symbiotics/immune products are excluded.

Inclusion Criteria

Your parents are willing and able to give permission, possess a smart phone, and complete weekly digital surveys.

My baby is healthy and I consent to their participation.

Exclusion Criteria

Prematurity (<= 36 weeks gestational age)

Any health issues identified at the first postpartum screening

I am using or plan to use donor breast milk.

Treatment Details

Interventions

• Enfamil Infant (Dietary Supplement)
• Enfamil NeuroPro (Dietary Supplement)

Trial Overview The study compares the gut bacteria in infants fed standard formula (Enfamil Infant), a new formula similar to breast milk (Enfamil NeuroPro), and breastfed infants. All formulas used meet FDA requirements and are commercially available.

Participant Groups

Group I: Enfamil Infant Experimental Treatment 1 Intervention

Group II: Enfamil NeuroPro Active Control 1 Intervention

Group III: Breast Milk Active Control 1 Intervention

Enfamil Infant is already approved in Canada for the following indications:

Approved in Canada as Enfamil Infant Formula for:

• Nutrition for infants from birth to 12 months

Who Is Running the Clinical Trial?

University of Arizona

Lead Sponsor

Trials

545

Recruited

161,000+

Mead Johnson Nutrition

Industry Sponsor

Trials

80

Recruited

15,900+

Findings from Research

The pediatric amino acid-based formula (AAF), EleCare, was found to be hypoallergenic and effective for children with cow's milk allergy (CMA) and multiple food allergies (MFA), as demonstrated in a study involving 31 children.

Over a median follow-up of 21 months, children maintained normal growth and showed improvements in certain blood markers, indicating that EleCare supports healthy development in allergic children.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hypoallergenicity and efficacy of an amino acid-based formula in children with cow's milk and multiple food hypersensitivities. Sicherer, SH., Noone, SA., Koerner, CB., et al.[2006]

Recent advancements in infant formula have introduced bioactive nutrients like long-chain polyunsaturated fatty acids, probiotics, and nucleotides to mimic the benefits of breast milk, supporting neurodevelopment and immune response.

While short-term studies show promise for these enhanced formulas, long-term follow-up is necessary to fully understand their impact on health outcomes, including obesity prevention and atopic disorders.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Closer to the gold standard: an appraisal of formulae available in Italy for use in formula-fed infants. Riva, E., Verduci, E., Agostoni, C., et al.[2017]

In a six-week study of 100 healthy infants, those fed the whey-predominant formula Nurture experienced significantly greater weight gain and head circumference growth compared to those fed the casein-predominant formula Vitamilk.

Infants on Nurture had better fatty acid profiles, with higher levels of oleic and linoleic acids, and experienced fewer issues with constipation, indicating it may be a more suitable option for bottle-fed infants.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A comparative trial of casein or whey-predominant formulae in healthy infants. Gunn, TR., Stunzner, D.[2013]

Infants who received formula with added bovine milk fat globule membrane (MFGM) and lactoferrin showed significantly improved cognitive, language, and motor development scores at 365 days compared to those on standard cow's milk-based formula, indicating enhanced neurodevelopmental outcomes.

The MFGM + lactoferrin group experienced fewer respiratory-related adverse events and instances of diarrhea, suggesting that this formula not only supports growth and development but also promotes better overall health in infants.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improved Neurodevelopmental Outcomes Associated with Bovine Milk Fat Globule Membrane and Lactoferrin in Infant Formula: A Randomized, Controlled Trial. Li, F., Wu, SS., Berseth, CL., et al.[2020]

Intestinal dysbiosis in preterm infants can lead to negative neurological outcomes, highlighting the importance of gut microbiota in brain development during critical growth periods.

Breastfeeding supports healthy gut microbiota and cognitive development in preterm infants, suggesting that enhancing infant formula with components found in breast milk could improve neurodevelopmental outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

New Insights Into Microbiota Modulation-Based Nutritional Interventions for Neurodevelopmental Outcomes in Preterm Infants. Buffet-Bataillon, S., Bellanger, A., Boudry, G., et al.[2023]

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

The Effects of a Partially Hydrolyzed Formula with Low Lactose and Probiotics on Mild Gastrointestinal Disorders of Infants: A Single-Armed Clinical Trial. [2023]

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

Clinical response to 2 commonly used switch formulas occurs within 1 day. [2013]

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

Hypoallergenicity and efficacy of an amino acid-based formula in children with cow's milk and multiple food hypersensitivities. [2006]

4. England pubmed.ncbi.nlm.nih.gov

Closer to the gold standard: an appraisal of formulae available in Italy for use in formula-fed infants. [2017]

5. New Zealand pubmed.ncbi.nlm.nih.gov

A comparative trial of casein or whey-predominant formulae in healthy infants. [2013]

6. France pubmed.ncbi.nlm.nih.gov

[Evidence-based dietetics: what has to be kept in mind for the prescription of infant formulae and follow-on formulae in 2007th?]. [2007]

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

Improved Neurodevelopmental Outcomes Associated with Bovine Milk Fat Globule Membrane and Lactoferrin in Infant Formula: A Randomized, Controlled Trial. [2020]

8. Korea (South) pubmed.ncbi.nlm.nih.gov

Middle East Consensus Statement on the Diagnosis and Management of Functional Gastrointestinal Disorders in [2020]

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

The clinical effect of a new infant formula in term infants with constipation: a double-blind, randomized cross-over trial. [2022]

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

Randomized double-blind study of the nutritional efficacy and bifidogenicity of a new infant formula containing partially hydrolyzed protein, a high beta-palmitic acid level, and nondigestible oligosaccharides. [2022]

11. Switzerland pubmed.ncbi.nlm.nih.gov

New Insights Into Microbiota Modulation-Based Nutritional Interventions for Neurodevelopmental Outcomes in Preterm Infants. [2023]