Infant Formula for Cow's Milk Allergy

Recruiting at 7 trial locations

Overseen By Jane Schlezinger

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: Abbott Nutrition

Must not be taking: Biologics, High potency steroids

Disqualifiers: Breastfeeding, Amino acid formula, others

Compensation: Varies

Number of Visits: Unknown

61 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a special formula for infants and children with a confirmed cow's milk allergy. Researchers aim to determine if the Experimental Extensively Hydrolyzed Formula can manage symptoms of cow's milk allergy (CMA) by comparing it to a placebo in a controlled setting. It suits children diagnosed with CMA who experience symptoms like hives or gastrointestinal issues and follow a strict cow's milk-free diet. Participants will try the formula in a food challenge and continue using it at home for a week. As an unphased trial, this study provides a unique opportunity for participants to contribute to important research that could improve management options for CMA.

Will I have to stop taking my current medications?

Participants must stop using oral steroids within 14 days and antihistamines within 7 days of the diagnosis and food challenges.

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

Research shows that the special formula under study is easy for children with cow's milk allergies to digest. One study found that children using these formulas grew and developed normally up to age five, indicating long-term safety. Another source confirms that these formulas are specifically made for children with allergies and sensitivities to cow's milk protein. This evidence suggests the formula is safe for infants and children with cow's milk allergies. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Experimental Extensively Hydrolyzed Formula for cow's milk allergy because it offers a new approach to managing this condition. Unlike most treatments that rely on complete elimination of cow's milk or using amino acid-based formulas, this formula breaks down milk proteins into smaller fragments, potentially reducing allergenic reactions while still providing nutritional benefits. Additionally, this formula can be administered both during food challenges and at home, offering more flexibility and convenience for families managing this allergy.

What evidence suggests that this trial's treatments could be effective for cow's milk allergy?

Research has shown that extensively hydrolyzed formulas are effective for babies with cow's milk allergies. These formulas break down milk proteins into smaller parts, reducing the likelihood of triggering an allergic reaction. In this trial, some participants will receive the Experimental Extensively Hydrolyzed Formula, which studies have found to be more effective than partially broken-down formulas at preventing allergies. Reviews have also shown that these formulas are safe and well-tolerated by babies. Evidence suggests they can lower the chance of allergies and might even help babies build tolerance over time. ^{1 6 7 8 9}

Are You a Good Fit for This Trial?

This trial is for infants and children between 3 months to 12 years old with a physician-confirmed diagnosis of IgE-mediated cow's milk allergy. They must have specific test results showing this allergy, been on a cow's milk protein-free diet for at least two weeks, and their parents agree to avoid giving them any cow's milk products during the study.

Inclusion Criteria

I have a severe allergy to cow's milk, confirmed by a skin test.

I have been diagnosed with a milk allergy confirmed by tests.

My blood test shows a high allergy indicator to milk.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Food Challenge

Participants undergo a double-blinded, placebo-controlled food challenge to assess reactions to the experimental formula

Up to 14 days

Open Feeding

Participants receive the experimental formula at home for 7 days to monitor for any reactions and assess intake

7 days

Follow-up

Participants are monitored for safety and effectiveness after the open feeding phase

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Experimental Extensively Hydrolyzed Formula
• Placebo Extensively Hydrolyzed Formula

Trial Overview The trial is testing an experimental extensively hydrolyzed formula against a placebo in kids with cow's milk allergy. It involves a blinded food challenge followed by seven days of feeding the experimental formula to see if it helps without causing allergic reactions.

How Is the Trial Designed?

Group I: Experimental Extensively Hydrolyzed Formula Experimental Treatment 1 Intervention

Administered during food challenge and at home feeding period of 7 days

Group II: Placebo Extensively Hydrolyzed Formula Placebo Group 1 Intervention

Administered during food challenge

Experimental Extensively Hydrolyzed Formula is already approved in European Union, United States, United Kingdom for the following indications:

Approved in European Union as Experimental Extensively Hydrolyzed Formula for:

• Cow's milk allergy
• Colic related to cow's milk allergy

Approved in United States as Experimental Extensively Hydrolyzed Formula for:

• Cow's milk allergy
• Colic related to cow's milk allergy

Approved in United Kingdom as Pepticate for:

• Cow's milk allergy
• Colic related to cow's milk allergy

Who Is Running the Clinical Trial?

Abbott Nutrition

Lead Sponsor

Trials

173

Recruited

33,700+

Robert B. Ford

Abbott Nutrition

Chief Executive Officer since 2020

Bachelor's degree from Boston College, MBA from UC Berkeley, Haas School of Business

Melissa Brotz

Abbott Nutrition

Chief Marketing Officer

Bachelor's degree in Journalism from Northwestern University

Published Research Related to This Trial

A systematic review of 15 randomized controlled trials found that a partially hydrolyzed whey formula (pHF) significantly reduces the risk of allergic diseases in infants at high risk for allergies compared to standard formula, particularly for atopic eczema and other allergic conditions.

While the pHF showed effectiveness in preventing allergies, the results should be viewed cautiously due to methodological limitations in many studies, although a well-designed independent trial provided strong supporting evidence.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Meta-analysis of the evidence for a partially hydrolyzed 100% whey formula for the prevention of allergic diseases. Szajewska, H., Horvath, A.[2015]

Four infants who were exclusively breastfed developed anaphylaxis after being fed a partially whey hydrolysate formula (PWHF), indicating that this formula may be allergenic even in babies who have not previously shown allergic symptoms.

The findings suggest that PWHF can sensitize genetically predisposed infants to cow's milk proteins, highlighting the importance of maternal diets during breastfeeding to prevent potential allergies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Allergenicity of a whey hypoallergenic formula in genetically at risk babies: four case reports. Cantani, A., Micera, M.[2015]

The extensive whey hydrolysate (eWH) showed no residual antigenicity or allergenicity in both in vitro assays and an in vivo mouse model for cow's milk allergy (CMA), indicating its safety for use in infants with CMA.

In a clinical study, over 90% of infants and children with confirmed CMA tolerated the eWH, further supporting its efficacy and safety as a hypoallergenic formula.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An In Vitro and In Vivo Translational Research Approach for the Assessment of Sensitization Capacity and Residual Allergenicity of an Extensive Whey Hydrolysate for Cow's Milk-Allergic Infants. Knipping, K., Buelens, L., Simons, PJ., et al.[2022]

Extensively hydrolyzed formulas (EHFs) are generally well-tolerated by children with cow's milk allergy (CMA), based on a systematic review of 15 trials involving 1285 children.

However, the review found no conclusive evidence favoring one EHF over another for CMA management, highlighting the need for standardized protocols and outcome measures in future studies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and safety of hydrolyzed formulas for cow's milk allergy management: A systematic review of randomized controlled trials. Stróżyk, A., Horvath, A., Meyer, R., et al.[2021]

In a study of 13 infants with chronic digestive symptoms, switching to an amino acid-based formula led to a decrease in symptoms and improved weight gain, indicating its efficacy for those allergic to extensively hydrolyzed protein formulas (EHFs).

All infants tested showed positive reactions to a challenge with EHF, suggesting that allergy to EHF should be considered in infants with cow milk allergies who continue to have symptoms on an EHF diet.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Allergy to extensively hydrolyzed cow milk proteins in infants: identification and treatment with an amino acid-based formula. de Boissieu, D., Matarazzo, P., Dupont, C.[2019]

A study involving 81 babies with cow's milk allergy showed that reactions to hydrolysate formulas (HFs), specifically Nidina HA, were similar to those experienced with whole cow's milk, indicating potential allergenicity.

The findings suggest that partial hydrolysate formulas may not only provoke reactions in sensitized individuals but can also be immunogenic in babies who are predisposed to allergies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Immunogenicity of hydrolysate formulas in children (Part 2): 41 case reports. Cantani, A., Micera, M.[2013]

In a study of 595 high-risk infants, those fed extensively hydrolyzed formulas (Nutramigen or Profylac) had a significantly lower incidence of cow's milk allergy compared to those fed a partially hydrolyzed formula (Nan HA), with rates of 0.6% versus 4.7%, respectively.

The study suggests that extensively hydrolyzed formulas are more effective in preventing cow's milk allergy in high-risk infants, although the overall incidence of atopic symptoms was low across all groups, indicating a potentially beneficial dietary intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of a partially hydrolyzed infant formula with two extensively hydrolyzed formulas for allergy prevention: a prospective, randomized study. Halken, S., Hansen, KS., Jacobsen, HP., et al.[2019]

Hydrolyzed rice formulas (HRF) are considered a suitable first-line alternative for managing cow's milk allergy (CMA) in infants when breastfeeding is not possible, as they are cow's milk protein-free and have proven hypoallergenicity.

Experts reached a consensus that HRFs can effectively support growth in infants with CMA, similar to other hypoallergenic formulas, making them a viable option in dietary management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hydrolyzed rice formula for dietary management of infants with cow's milk allergy. Fiocchi, A., Barrio-Torres, J., Dupont, C., et al.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8401609/

Hydrolysed Formulas in the Management of Cow's Milk ... This review aims to summarize the current evidence concerning different types of hydrolysed formulas (HF), and recommendations for the treatment ...

2. researchgate.net researchgate.net/publication/327520495_Palatability_of_Hypoallergenic_Formulas_for_Cow's_Milk_Allergy_and_Healthcare_Professional_Recommendation

Palatability of Hypoallergenic Formulas for Cow's Milk ... Safety and efficacy of a new extensively hydrolyzed formula for infants with cow's milk protein allergy. Article. Jun 2008; PEDIATR ALLERGY IMMU.

3. perrigopediatrics.com perrigopediatrics.com/cows-milk-allergy/

Cow's Milk Allergy - Hypoallergenic - Perrigo Pediatrics This hypoallergenic formula uses extensively hydrolyzed cow's milk proteins, reducing allergenicity by reducing peptide size and using free amino acids and ...

4. researchgate.net researchgate.net/publication/12339800_Comparison_of_a_partially_hydrolyzed_infant_formula_with_two_extensively_hydrolyzed_for_allergy_prevention_A_prospective_randomized_study

Comparison of a partially hydrolyzed infant formula with ... Partially hydrolyzed formula was found to be less effective than extensively hydrolyzed formula in preventing cow's milk allergy, 0.6% vs.

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9843608/

Differences between peptide profiles of extensive ... This short review aims to highlight the variability in peptides and their ability to influence allergenicity and possibly the induction of tolerance by ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5243874/

Long-term safety assessment in children who received ... Extensively and partially hydrolyzed formulas with LGG were associated with normal growth and development and long-term safety through 5 years of age.

7. medical.gerber.com medical.gerber.com/sites/default/files/2022-10/Extensive-HA-Resource-Guide.pdf

Extensive HA® - Gerber Medical Hub Extensive HA® Infant Formula. Scientifically designed for. Cow's milk protein allergy and intolerance. Cow's milk-induced FPIES*. Soy protein sensitivity. Fat ...

8. medium.com medium.com/@santacrz1988/the-best-hypoallergenic-formulas-a-guide-to-european-and-us-hypoallergenic-formulas-132ccfa06ae1

The Best Hypoallergenic Formulas: A Guide to European ... If your child's milk protein sensitivity is mild, then partially hydrolyzed formulas are generally the best and cleanest option. If, on the ...

9. nestlemedicalhub.com nestlemedicalhub.com/products/extensive-ha

Extensive HA® Whey Protein Formula It is scientifically designed for cow's milk protein allergy (CMPA) and intolerance, cow's milk-induced food protein-induced enterocolitis syndrome (FPIES) ...