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

NCT03769051 | Completed

• 1 other identifier: 20180402 v1.3
• Study Type: observational
• Target: 200
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Cow's Milk Protein Allergy

Keywords

Cow's Milk Protein allergy; Open Food Challenge test; Immune Tolerance; Amino Acid Formula

Outcome Measures

Primary Outcomes (1)

• Negative rate of open food challenge test

  Negative rate =The subjects number with negative results of open food challenge test/total subject number with open food challenge test Unit:% Negative rate range: 0-100% High negative rate indicates the immune tolerance of CMPA infant using AAF

  From baseline to AAF feeding for 6 months

Secondary Outcomes (7)

• WAZ(weight for age Z score)

  From baseline to AAF feeding for 6 months

• HAZ(height for age Z score)

  From baseline until AAF feeding for 6 months

• HCAZ(head circumference for age Z score)

  From baseline to AAF feeding for 6 months

• SCORAD score

  From baseline to AAF feeding for 6 months

• Gastrointestinal symptom score

  From baseline to AAF feeding for 6 months

Eligibility Criteria

• Age: 1 Day - 6 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

Cow's milk protein allergy infants in 0\~6 months

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Peking University Third Hospital: lead

MeSH Terms

Conditions

Milk Hypersensitivity

Condition Hierarchy (Ancestors)

Food Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Juan Zhang

  Colleague

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 1, 2018
• First Posted: December 7, 2018
• Study Start: June 20, 2015
• Primary Completion: February 28, 2019
• Study Completion: April 1, 2019
• Last Updated: September 6, 2019

Record last verified: 2018-11