Enfamil NeuroPro for Infant Gut Health

Overseen By Fayez Ghishan, MD

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: University of Arizona

Must not be taking: Prebiotics, Probiotics, Symbiotics, others

Disqualifiers: Prematurity, C-section, Health issues, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 16 weeks

240 Participants Needed

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.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but parents must avoid giving their child prebiotics, probiotics, symbiotics, and immune-stimulating products 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 data supports the effectiveness of the treatment Enfamil NeuroPro for Infant Gut Health?

Research shows that partially hydrolyzed formulas with low lactose and probiotics can improve mild gastrointestinal disorders in infants, reducing symptoms like vomiting and gas within a few days. This suggests that similar formulas, like Enfamil NeuroPro, may also support infant gut health. ^{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 safe for infants?

Research on various infant formulas, including those with similar components to Enfamil NeuroPro, suggests they are generally safe for infants. Studies have shown that these formulas are well-tolerated, with some benefits for gastrointestinal health and growth, and no significant adverse events reported. ^{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}

How does Enfamil NeuroPro differ from other treatments for infant gut health?

Enfamil NeuroPro is unique because it includes a blend of partially hydrolyzed proteins, low lactose, and probiotics, which may help improve mild gastrointestinal disorders in infants by reducing symptoms like vomiting and flatulence early in the treatment. This combination aims to support both gut health and neurodevelopment, unlike standard formulas that may not address these specific needs. ^{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.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Infants are fed either breast milk, Enfamil Infant formula, or Enfamil NeuroPro formula from birth to 4 months

16 weeks

Monthly visits for sample collection

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Enfamil Infant
• Enfamil NeuroPro

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 United States, Canada, European Union for the following indications:

Approved in United States as Enfamil Infant Formula for:

• Nutrition for infants from birth to 12 months

Approved in Canada as Enfamil Infant Formula for:

• Nutrition for infants from birth to 12 months

Approved in European Union 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

In a study of 80 full-term infants with mild gastrointestinal disorders, feeding a partially hydrolyzed formula (pHF) for 14 days significantly reduced gastrointestinal symptoms, as measured by the Infant Gastrointestinal Symptom Questionnaire (IGSQ), with scores decreasing from 36.0 at baseline to 26.5 by Day 14 (p < 0.001).

The prevalence of digestive distress also dropped dramatically from 87.5% at the start to 28.8% by Day 14 (p < 0.001), indicating that pHF may effectively alleviate mild gastrointestinal issues in infants without any reported adverse events.

NCBI (Pubmed)

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. Huang, Y., Zhou, Y., Li, H., et al.[2023]

In a 28-day study involving 159 fussy infants, both soy-based formula and partially hydrolyzed cow's milk protein formula significantly reduced fussiness, gas, spit-up, and crying within just one day of intake, with improvements maintained throughout the study.

The partially hydrolyzed formula (PHF) not only improved symptoms of formula intolerance but also maintained consistent stool consistency, unlike the soy formula, which led to firmer stools by day 2.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical response to 2 commonly used switch formulas occurs within 1 day. Berseth, CL., Johnston, WH., Stolz, SI., et al.[2013]

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]

All infant and follow-on formulae on the market are of high quality, but they are not identical, and recent innovations may offer functional benefits for some infants.

The choice of infant formula should primarily be based on the protein source, with cow's milk protein being the first choice unless the infant is at risk for allergies, in which case hypoallergenic formulas are recommended.

NCBI (Pubmed)

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]

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]

Anti-regurgitation formulas can be helpful for infants experiencing troublesome regurgitation, but diagnostic tests or medications are not necessary unless there are warning signs.

Lactulose is safe and effective for treating constipation in infants under 6 months, while macrogol (PEG) is preferred for those over 6 months, and dietary interventions like partially hydrolyzed formulas may help with functional constipation and infantile colic when cow's milk protein allergy is not suspected.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Middle East Consensus Statement on the Diagnosis and Management of Functional Gastrointestinal Disorders in Vandenplas, Y., Alturaiki, MA., Al-Qabandi, W., et al.[2020]

In a study of 38 constipated infants, Nutrilon Omneo (NF) formula showed a strong tendency to improve stool consistency, with 90% of infants experiencing softer stools compared to 50% with the standard formula, although this was not statistically significant.

While both formulas increased defecation frequency, there was no significant difference between NF and the standard formula, suggesting that NF may be particularly beneficial for infants with hard stools rather than for increasing the number of bowel movements.

NCBI (Pubmed)

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. Bongers, ME., de Lorijn, F., Reitsma, JB., et al.[2022]

The new infant formula (NF) demonstrated better weight and head circumference growth in girls during the first 6 weeks compared to the standard formula (SF), although this difference did not persist through the 12-week study.

NF resulted in a higher proportion of bifidobacteria in stools at 6 weeks, indicating improved gut health, while both formulas were well tolerated and showed no significant differences in blood biochemical measures.

NCBI (Pubmed)

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. Schmelzle, H., Wirth, S., Skopnik, H., et al.[2022]

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]