Impact of Infant Formula on Resolution of Cow's Milk Allergy

This is an interventional basic science trial for Milk Allergy focused on measuring milk, allergy, tolerance Read More

Inclusion Criteria (to consent):

• Infants 0-120 days of age with suspected CMA, as determined by the pediatrician or specialist, will be referred to the study. A Standard Operating Procedures (SOP) document will be provided for the clinicians to help guide their referral to the study. Physician diagnosis of CMA will be based on the following:
• Physician documented, gross or persistent microscopic blood in stool (3 positive guaiac cards on three separate stools) in the absence of other explanation (e.g., fissure, moderate-to-severe constipation) AND / OR

Infant with at least one gastrointestinal, dermatological, or respiratory allergic manifestation suggestive of CMA:

• Gastrointestinal: Chronic Diarrhea, Constipation or Vomiting/Gastro-esophageal reflux
• Dermatologic: Atopic Dermatitis or Urticaria
• Respiratory: Cough, Allergic rhinitis or Recurrent Wheezing
• General:Colic / Irritability
• No change in treatment with medications during the 7 days preceding the elimination diet and no expected change in medications during the DBPCFCs (unless otherwise medically necessary)
• Signed informed consent obtained for infants participation in the study
• Signed authorization obtained to use and/or disclose Protected Health Information for infant from birth through the length of the study period

• Willingness to comply with following inclusion criteria if found to have a positive DBPCFC screen:

  1. Caregiver(s) agree to comply with the infant elimination diet given to them by the investigator for the duration of the study
  2. Mother agrees to follow an elimination diet throughout duration of breast feeding
  3. Parent(s) or legally authorized representative agrees not to enroll infant in another interventional clinical study while participating in this study

Inclusion Criteria (to randomization):

• Positive Double Blind Placebo Controlled Food Challenge (DBPCFC).

Exclusion Criteria (to consent):

• History of anaphylaxis to milk
• Use of probiotics
• Use in the previous 4 weeks of systemic steroids
• Use of systemic immunomodulatory treatment, including biologics with an immune target such as Xolair
• Known eosinophilic GI disorders
• Episode(s) of severe repetitive vomiting and lethargy prompting an emergency room visit and occurring within 4 hours of ingesting a milk protein (i.e. consistent with FPIES)
• Co-existing autoimmune or other chronic disease or serious health problem, including celiac disease, inflammatory bowel disease, malignancy, congenital, metabolic or genetic disorders or malformations
• Intention to exclusively breast feed
• Infants born at less than 36 weeks gestation (35 weeks + 6 days is considered 35 weeks gestation)

Exclusion Criteria (to randomization):

• Severe reaction to Milk Protein during the DBPCFC