FARE Clinical Trial Finder

Simplify your search for a clinical trial and help researchers discover new therapies. The FARE Clinical Trial Finder links patients with food allergy and healthy, non-patient volunteers to actively recruiting food allergy studies.

Evaluation of the Hypoallergenicity of a New Formula Based on Hydrolyzed Rice Proteins

Study Purpose

The aim of this study is to show the hypoallergenicity of a new thickened rice based formula (TRHF) through a double blind placebo controlled food challenge (DBPCFC), as recommended by the American Academy of Pediatrics, in subjects with IgE-mediated CMA and in subjects with non-IgE-mediated CMA.

Recruitment Criteria

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

Accepts Healthy Volunteers
No

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.

Study Type
Interventional
Eligible Ages 1 Month - 36 Months
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

- with suspected CMA or with a CMA diagnosed by a DBPCFC performed in the last 2 months prior to inclusion - free of clinical allergic symptoms for at least one week (i.e. successfully fed an elimination diet); - whose parents signed the informed consent

Exclusion Criteria:

- mainly breast fed, drinking less than 250ml of formula/day, presenting any situation, which, according to the investigator, may interfere with the study participation or lead to a particular risk for the subject

Trial Details

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.

Trial ID:
NCT03557671

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.

Phase
N/A

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Lead Sponsor
United Pharmaceuticals

The person who is responsible for the scientific and technical direction of the entire clinical study.

Principal Investigator
Roberto Berni Canani
Principal Investigator Affiliation University Federico II

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Agency Class
IndustryOther
Overall Status Recruiting
Countries Belgium, France, Italy

The disease, disorder, syndrome, illness, or injury that is being studied.

Conditions
Cow Milk Allergy
Additional Details

The study is made of 2 different steps : 1st step is a double blind randomised food challenge where the new formula is compared to a placebo. The second part of the trial consists in an open phase during which all infants will be fed with the study 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

University of Naples Federico II, Naples, Italy

Status

Recruiting

Address

University of Naples Federico II

Naples, ,

Hopital Trousseau, Paris, France

Status

Not yet recruiting

Address

Hopital Trousseau

Paris, ,

CHR Namur, Namur, Belgium

Status

Not yet recruiting

Address

CHR Namur

Namur, ,

The content provided on clinical trials is for informational purposes only and is not a substitute for medical consultation with your healthcare provider. We do not recommend or endorse any specific study and you are advised to discuss the information shown with your healthcare provider. While we believe the information presented on this website to be accurate at the time of writing, we do not guarantee that its contents are correct, complete, or applicable to any particular individual situation. We strongly encourage individuals to seek out appropriate medical advice and treatment from their physicians. We cannot guarantee the availability of any clinical trial listed and will not be responsible if you are considered ineligible to participate in a given clinical trial. We are also not liable for any injury arising as a result of participation.