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

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ClinicalTrials.gov Identifier: NCT03769051
Recruitment Status : Completed
First Posted : December 7, 2018
Last Update Posted : September 5, 2019
Sponsor:
Information provided by (Responsible Party):
Peking University Third Hospital

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.

Condition or disease
Cow's Milk Protein Allergy

Detailed Description:
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).

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Study Type : Observational
Actual Enrollment : 200 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Study on The Oral Immune Tolerance of CMPA Infants Using Amino Acid Formula
Actual Study Start Date : June 20, 2015
Actual Primary Completion Date : February 28, 2019
Actual Study Completion Date : April 2019

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  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 Outcome Measures :
  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



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Ages Eligible for Study:   up to 6 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Cow's milk protein allergy infants in 0~6 months
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03769051


Sponsors and Collaborators
Peking University Third Hospital
Investigators
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Study Director: Juan Zhang Colleague

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Responsible Party: Peking University Third Hospital
ClinicalTrials.gov Identifier: NCT03769051     History of Changes
Other Study ID Numbers: 20180402 v1.3
First Posted: December 7, 2018    Key Record Dates
Last Update Posted: September 5, 2019
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Peking University Third Hospital:
Cow's Milk Protein allergy
Open Food Challenge test
Immune Tolerance
Amino Acid Formula
Additional relevant MeSH terms:
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Hypersensitivity
Immune System Diseases