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Completed

NCT Number: NCT03769051

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

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.

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Key information

Conditions

Cow's Milk Protein Allergy Food Hypersensitivity Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Milk Hypersensitivity

Age range

1 day–6 month

Sex eligibility

All sexes

Study type

Observational

About this study

This is a multi-center, prospective cohort study. This study plans to recruit 200 subjects. The suitable subject will be enrolled and there are seven visits through the 6-month study. Efficacy parameters are the positive incidence of open food challenge test, growth and development index (Weight, Height, Head circumference;), and the improvement of CMPA symptoms (such as SCORAD, gastrointestinal tract, respiratory, comfort scores).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Negative rate of open food challenge test

    Time frame: From baseline to AAF feeding for 6 months

    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

Secondary outcomes

  1. WAZ(weight for age Z score)

    Time frame: From baseline to AAF feeding for 6 months

    Z-scores of anthropometric parameters from baseline on weight=Average(The difference between the measured infant weight and the reference infant weight of the same age and sex/the reference infant weight standard deviation) The increase of WAZ indicated that AAF could promote growth and development.

  2. HAZ(height for age Z score)

    Time frame: From baseline until AAF feeding for 6 months

    Z-scores of anthropometric parameters from baseline on height=Average(The difference between the measured infant height and the reference infant height of the same age and sex/the reference infant height standard deviation) The increase of HAZ indicated that AAF could promote growth and development.

  3. HCAZ(head circumference for age Z score)

    Time frame: From baseline to AAF feeding for 6 months

    Z-scores of anthropometric parameters from baseline on head circumference=Average(The difference between the measured infant head circumference and the reference infant head circumference of the same age and sex/the reference infant head circumference standard deviation) The increase of HCAZ indicated that AAF could promote growth and development.

  4. SCORAD score

    Time frame: From baseline to AAF feeding for 6 months

    An SCORAD evaluation scale was evaluated by the investigator at each visit

  5. Gastrointestinal symptom score

    Time frame: From baseline to AAF feeding for 6 months

    An Gastrointestinal symptom evaluation scale was evaluated by the investigator at each visit

  6. Respiratory symptom score

    Time frame: From baseline to AAF feeding for 6 months

    An Respiratory symptom evaluation scale was evaluated by the investigator at each visit

  7. Comfort symptom score

    Time frame: From baseline to AAF feeding for 6 months

    An Comfort symptom evaluation scale was evaluated by the investigator at each visit

Sponsors and collaborators

Lead sponsor

Peking University Third Hospital

Other

Registry information

Important dates

Study start
2015
Primary completion
2019
Study completion
2019
First posted
Dec 7, 2018
Registry last updated
Sep 6, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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