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

Trial Summary

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.

What data supports the effectiveness of the treatment for cow's milk allergy?

Research shows that extensively hydrolyzed formulas (EHFs) are more effective than partially hydrolyzed formulas in preventing cow's milk allergy in infants, with a lower incidence of allergy reported in those fed EHFs. ^{1 2 3 4 5}

Is the extensively hydrolyzed formula safe for infants with cow's milk allergy?

Extensively hydrolyzed formulas (EHFs) are generally considered safe for infants with cow's milk allergy, but some infants may still have allergic reactions to them. In such cases, an amino acid-based formula might be recommended as an alternative. ^{2 3 5 6 7}

How is the treatment for cow's milk allergy using extensively hydrolyzed formula different from other treatments?

The extensively hydrolyzed formula (eHF) is unique because it breaks down cow's milk proteins into smaller pieces, making them less likely to cause an allergic reaction in infants with cow's milk allergy. This treatment is more effective in preventing cow's milk allergy compared to partially hydrolyzed formulas, as it significantly reduces the allergenic potential of the milk proteins. ^{1 2 3 5 8}

What is the purpose of this trial?

This is a multi-center, randomized, double-blinded, placebo-controlled food challenge to be conducted in infants and children with confirmed IgE-mediated cow's milk allergy (CMA), followed by a 7-day open feeding of the experimental formula.

Eligibility Criteria

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 been diagnosed with a milk allergy confirmed by tests.

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

My blood test shows a high allergy indicator to milk.

Timeline

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

Treatment Details

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.

Participant Groups

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

Findings from Research

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]

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]

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]

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]

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]

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]

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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

Comparison of a partially hydrolyzed infant formula with two extensively hydrolyzed formulas for allergy prevention: a prospective, randomized study. [2019]

2. Italy pubmed.ncbi.nlm.nih.gov

Allergenicity of a whey hypoallergenic formula in genetically at risk babies: four case reports. [2015]

3. England pubmed.ncbi.nlm.nih.gov

Efficacy and safety of hydrolyzed formulas for cow's milk allergy management: A systematic review of randomized controlled trials. [2021]

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

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

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

Allergy to extensively hydrolyzed cow milk proteins in infants: identification and treatment with an amino acid-based formula. [2019]

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

Hydrolyzed rice formula for dietary management of infants with cow's milk allergy. [2022]

7. Spain pubmed.ncbi.nlm.nih.gov

Immunogenicity of hydrolysate formulas in children (Part 2): 41 case reports. [2013]

8. Switzerland 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. [2022]