CompletedNot Applicable

Step Down Approach in Children With Cow Milk Allergy

Italy60 participantsStarted 2018-04-01

Plain-language summary

Cow's milk allergy (CMA) affects up to 3% of European children. In the absence of an alternative to cow's milk, the management of CMA is based on the use of safe, affordable and nutritionally adequate formulas. In Scientific Societies Guidelines, extensively hydrolyzed casein formula (EHCF) is considered as safe first line approach for the treatment of children with CMA, whereas amino acid-based formula (AAF) is considered as second line strategy in children reacting to EHCF or as first line approach in children with CMA-induced anaphylaxis. Few and not recent studies, involving a poorly characterized study population, suggested that up to 10% of CMA children could react to the extensively hydrolysed formulas. It has been demonstrated that EHCF supplemented with L.rhamnosus GG (LGG) maintains hypoallergenic status and that is able to accelerate oral tolerance acquisition in children with CMA comparing with other formulas. The purpose of this study is to investigate the feasibility of a "step-down" approach in children affected by Immunoglobulin E (IgE)-mediated CMA with the aim to evaluate the effects of EHCF + LGG on oral tolerance acquisition and on immune response and gut microbiota shaping.

Who can participate

Age range0 Months – 6 Months

SexALL

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: * Infants aged \<6 months * sure diagnosis of IgE-mediated CMA confirmed by positive oral food challenge for cow's milk and or blood Cow milk protein specific IgE\>0.1kiloUnits/Liter and/or Skin Prick Testing (SPT) for milk wheal size ≥ 3mm * children receiving AAF for at least 4 weeks * full and stable remission of CMA symptoms. Exclusion Criteria: * Infant aged \> 6 months, * CMP-induced anaphylaxis, * evidence of non-IgE-mediated CMA, * other food allergies, * other allergic diseases, * eosinophilic disorders of the gastrointestinal tract, * chronic systemic diseases, * congenital cardiac defects, * active tuberculosis, * autoimmune diseases, * immunodeficiency, * chronic inflammatory bowel diseases, * celiac disease, * cystic fibrosis, * metabolic diseases, * malignancy, * chronic pulmonary diseases, * malformations of the gastrointestinal and/or respiratory tract, * administration of prebiotics or probiotics during the 4 weeks before enrolment, * use of systemic antibiotics or anti-mycotic drugs during 4 weeks before study entry; * investigator's uncertainty about the willingness or ability of the subject to comply with the protocol requirements; * participation in any other studies involving investigational or marketed products concomitantly or within two weeks prior to entry into the study.

What they're measuring

Evaluation of the tolerance rate of EHCF+LGG in CMA children treated with AAF

Timeframe: after the first oral food challenge, i.e. after 7-15 days after inclusion

Trial details

NCT IDNCT03449537

SponsorFederico II University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2020-10-28