CompletedNot Applicable

Study on The Oral Immune Tolerance of CMPA Infants Using Amino Acid Formula

200 participantsStarted 2015-06-20

Plain-language summary

The main purpose of this study was to observe the effect of amino acid formula on infants with cow's milk protein allergy; to evaluate the role of food avoidance and Open Food Challenge test in the diagnosis of infants with cow's milk protein allergy; to observe the allergic process in infants with cow's milk protein allergy and to explore the criteria for diagnosis and treatment.

Who can participate

Age range1 Day – 6 Months

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Age: 0 to 6 months; * Subject with cow's milk protein allergy (any clinical signs or symptoms of the skin, gastrointestinal tract, respiratory tract or comfortable tract) * Unable to breastfeed; * Vital signs are stable; * Legal guardian has signed the informed consent. Exclusion Criteria: * Subject with congenital and hereditary metabolic diseases; * Digestive tract obstruction; * Subject with immunodeficiency diseases; * Subject who is allergic to known components of amino acid formula powder; * The investigator judges it is not suitable for the subject to participate in this study.

What they're measuring

Negative rate of open food challenge test

Timeframe: From baseline to AAF feeding for 6 months

Trial details

NCT IDNCT03769051

SponsorPeking University Third Hospital

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2019-02-28

View on ClinicalTrials.gov More Cow's Milk Protein Allergy trials