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Non-interventional Research Clinical Research Program for Establishment of Milk Protein Allergy Oral Immune Tolerance

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03769051
Recruitment Status : Active, not recruiting
First Posted : December 7, 2018
Last Update Posted : December 7, 2018
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 powder on alleviating food allergies in infants; to evaluate the role of food avoidance and open-ended stimulation test in the diagnosis of food-allergic infants; to observe the allergic process in children with food allergy and to explore the criteria for diagnosis and treatment. The baby here refers to an infant between the ages of birth and 6 months of age.

This study used a multicenter, prospective cohort study. Nine research units conducted research at the same time in different locations at different locations to ensure the scientific, authenticity, objectivity and reliability of the research conclusions.

The number of design samples in this trial was 180. Considering the exit rate of no more than 10%, a total of 200 cases were completed.


Condition or disease
Milk Protein Allergy

Detailed Description:

This study used multi-center, prospective cohort study. Nine research units conducted the research in different locations according to the same program at the same time to ensure the scientific, authenticity, objectivity and reliability of the research conclusion.

A total of 180 samples were designed for completion, taking into account the withdrawal rate of no more than 10%.

The inclusion criteria age: 0 ~ 6 months clinical doctors diagnosed with food protein in children with allergic (any of the skin, gastrointestinal tract or respiratory symptoms or signs) Mother feeding Life is stable Legal custodian signed informed consent Exclusion criteria all kinds of congenital, children with inherited metabolic diseases Gastrointestinal obstruction Children with immune deficiency disease The mixture of ammonia base acid is known to be allergic Researchers identify as disqualified Exit criteria Where the child/parent or guardian has the right to withdraw from the study at any time for any reason; If the disease is aggravated within 48 hours of treatment, the patient should withdraw from the trial and be treated as invalid.

Patients were asked to withdraw from the study if they were unable to continue to participate in the study, such as complications, adverse events, violations of protocol, or reasons for taking medication.

Follow-up arrangement The observation period of each child was 6 months, followed up once a month. Follow up 1 year after observation.

Validity index main outcome indicators: open food provocation tests positive incidence; secondary outcome indicators: body weight, body length, head circumference and arm muscle circumference; Improvement of food protein allergy symptoms (SCORAD, gi, respiratory, comfort scores).

Clinical trial procedure

All children should complete the following contents before entering the study:

The parent/guardian signs a written informed consent Audit inclusion/exclusion criteria Molly I have general information Physical examination, including vital signs, weight, abdominal signs, systemic conditions Routine blood test, stool test, IgE test. The researcher should inform the child and his/her parent/guardian of the date of the next visit.

If the child withdraws, the reason for withdrawal should be recorded in the case report form.


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Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Non-interventional Research Clinical Research Program for Establishment of Milk Protein Allergy Oral Immune Tolerance
Actual Study Start Date : June 20, 2015
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Allergy
Drug Information available for: Casein




Primary Outcome Measures :
  1. Positive incidence of open food challenge test [ Time Frame: Six months ]
    Nothing


Secondary Outcome Measures :
  1. weight in kilograms [ Time Frame: Six months ]
    Nothing

  2. height in centimeters [ Time Frame: Six months ]
    Nothing

  3. head circumference in centimeters [ Time Frame: Six months ]
    Nothing

  4. arm muscle circumference in centimeters [ Time Frame: Six months ]
    Nothing

  5. SCORAD score [ Time Frame: Six months ]
    For evaluating the severity of atopic dermatitis, the scores below 25 were mild, 20-50 were moderate and above 50 were severe.

  6. Gastrointestinal symptom score [ Time Frame: Six months ]
    Nothing

  7. Respiratory symptom score [ Time Frame: Six months ]
    No respiratory symptoms were 0, mild respiratory symptoms were 1, mild respiratory symptoms were 2, and severe respiratory symptoms were 3.

  8. comfort index score [ Time Frame: Six months ]
    Nothing



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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
Confirmed milk protein allergy children
Criteria

Inclusion Criteria:

  • Age: 0 to 6 months A clinician suspects a child with food protein allergy (any clinical signs or symptoms of the skin, gastrointestinal tract or respiratory tract) Unable to breastfeed Vital signs are stable Legal guardian signs informed consent

Exclusion Criteria:

  • children with congenital and hereditary metabolic diseases Digestive tract obstruction Children with immunodeficiency diseases Those who are allergic to known components of amino acid formula powder Researchers believe that it is not suitable for the group

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: December 7, 2018
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:
Milk protein allergy
Open challenge test
Allergic process
Food avoidance

Additional relevant MeSH terms:
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Hypersensitivity
Food Hypersensitivity
Milk Hypersensitivity
Immune System Diseases
Hypersensitivity, Immediate
Caseins
Chelating Agents
Sequestering Agents
Molecular Mechanisms of Pharmacological Action