Evaluation of Tolerance, Efficacy and Safety of an Hydrolyzed Formula in Infants With IgE/Non-IgE Mediated CMA.

Study Purpose

The aim of this interventional study is to assess the hypoallergenicity of a new formula in infants having a cow milk allergy (CMA), whatever the type of CMA, meaning in both IgE-mediated and non-IgE-mediated CMA patients. This will be tested through a double-blind placebo controlled food challenge (DBPCFC) taking place over 2 or 3 separate days, in hospital. If the child tolerates the tested formula during the DBPCFC, he will be fed with the test formula during the second study phase. There will be monthly visit and parents will be asked to fill in diaries.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	1 Month - 24 Months
Gender	All

More Inclusion & Exclusion Criteria

Inclusion Criteria:

- between 1 and 24 months old.

- having a CMA proven in the last 3 months prior to inclusion.

- free of clinical allergic symptoms for at least one week (i.e., successfully fed an elimination diet) - whose parent(s)/legal guardian(s) signed the informed consent form.

Main

Exclusion Criteria:

- Children mainly (>1 breastfeeding/day) or exclusively breastfed, with maternal willingness to continue breast-feeding.

- Children with a mean formula intake lower than 250 ml/day.

- Children with past anaphylactic reaction(s) - Children with chronic (non acute) FPIES.

-- Children presenting with any situation which, according to the investigator, may interfere with the study participation, or lead to a particular risk for the subject, - Children already participating in another clinical trial

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT06481280
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	N/A
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	United Pharmaceuticals
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Salvatore OLIVA, MD, PhD
Principal Investigator Affiliation	University Hospital - Umberto I
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Industry, Other
Overall Status	Active, not recruiting
Countries	Belgium, Italy
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Cow's Milk Allergy

Additional Details

Briefly, on two separate days, the placebo formula and the TEHCF will be introduced at increasing doses under medical supervision, and appearance of allergic symptoms will be witnessed and recorded if any. The week after, and more particularly the 72 hours after each food challenge day, child's parents will be instructed to report to the investigator any delayed reaction that may occur. In case the TEHCF induces an allergic reaction, the child's participation will be ended. Otherwise, the child will enter the second study part, lasting 4 months and during which the usual formula taken by the child will be totally replaced by the TEHCF.

Arms & Interventions

Arms

Experimental: Test Formula

Infants will receive an extensively hydrolyzed formula during the double-blind placebo-controlled food challenge (DBPCFC) and will continue on this formula during the open-label feeding phase if they tolerate it.

Placebo Comparator: Placebo Formula

Infants will receive a placebo formula (=their previous formula) during the DBPCFC to compare against the test formula.

Interventions

Dietary Supplement: - Test Formula

Dietary Supplement: - Placebo Formula

Infants will receive a placebo formula during the DBPCFC to compare against the test formula.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Private practice Elena BRADATAN, Namur, Begium, Belgium

Status

Address

Private practice Elena BRADATAN

Namur, Begium, 5000

University Hospital - Umberto I Sapienza, Roma, Italy

Status

Address

University Hospital - Umberto I Sapienza

Roma, , 00161

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