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 range

1 Day – 6 Months

Sex

ALL

See this in plain English?

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

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