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Cow's Milk Allergy clinical trials

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NCT ID: NCT06456541 Not yet recruiting - Cow's Milk Allergy Clinical Trials

Infant Formula in Infants and Children With Cow's Milk Allergy

Start date: July 2024
Phase: N/A
Study type: Interventional

This is a multi-center, randomized, double-blinded, placebo-controlled food challenge to be conducted in infants and children with confirmed IgE-mediated cow's milk allergy (CMA), followed by a 7-day open feeding of the experimental formula.

NCT ID: NCT06134466 Recruiting - Allergy Clinical Trials

Hypoallergenicity of a New Formula in Subjects With Cow's Milk Allergy

NIQA
Start date: February 13, 2024
Phase: N/A
Study type: Interventional

Cow's milk protein allergy (CMA) is an immune-mediated reaction which can either be antibody-driven (IgE-mediated) or cell-mediated (non-IgE-mediated) or mixed, and elicits reactions which are reproducible upon re-exposure to cow's milk proteins. Estimates of CMA prevalence depend on the diagnosis procedure used; recently, a meta-analysis stated an overall pooled estimate for 0-1 year old infants of point prevalence of CMA reported by parents of 4.2% (95 % confidence interval (CI): 3.2-5.4), decreasing to 2.0% (1.5-2.5) when CMA was proven with a double-blind placebo-controlled food challenge (DBPCFC). CMA manifests through diverse and non-specific symptoms, rendering the CMA diagnosis very difficult. CMA symptoms mainly concern the cutaneous area, the respiratory and gastrointestinal tracts but can also be general. The DBPCFC is therefore considered as the gold standard for the CMA diagnosis. CMA management consists in the elimination of any source of non-hydrolyzed cow' milk protein from the diet, which is mainly achieved in children by using extensively hydrolyzed formulae (eHFs). As the molecular weight profile of a given hydrolysate cannot predict potential reaction in a given child, the American Academy of Pediatrics recommended that tolerance/hypoallergenicity of any formula intended for children with CMA should be clinically tested in that specific population. The purpose of this study is to demonstrate the hypoallergenicity of a new liquid hydrolyzed casein-based formula (Investigational Formula) in the management of infants and children with CMA.

NCT ID: NCT05883384 Recruiting - Cow's Milk Allergy Clinical Trials

Validity of Cow's Milk-related Symptom Score Among Children Suspected to Have Cow's Milk Protein Alergy

Start date: January 1, 2023
Phase:
Study type: Observational

Cow's milk protein allergy is a sensitivity reaction against cow's milk protein and and is calcified as IgE-medaited, non- IgE mediated and mixed type according to the underlying immunological mechanism. Cow's Milk related Symptom Score ( CoMiSS) Considers general manifestation and dermatological, gastrointestinal and respiratory symptoms.

NCT ID: NCT05731206 Suspended - Cow's Milk Allergy Clinical Trials

Hypoallergenicity of a Hydrolyzed Protein Infant Formula

HYPO STORY
Start date: July 31, 2024
Phase: N/A
Study type: Interventional

Study to demonstrate hypoallergenicity of a hydrolysed protein infant formula in a population of children with confirmed cow's milk allergy.

NCT ID: NCT04910373 Terminated - Cow's Milk Allergy Clinical Trials

Extensively Hydrolyzed Infant Formula in Infants and Children With Cow's Milk Allergy

Start date: January 25, 2022
Phase: N/A
Study type: Interventional

This is a multi-center, randomized, double-blind, placebo-controlled food challenge to be conducted in infants or children with confirmed IgE-mediated cow's milk allergy (CMA), followed by a 7-day open feeding of the experimental formula.

NCT ID: NCT04492683 Recruiting - Cow's Milk Allergy Clinical Trials

Diagnostic Accuracy and Safety of DBV1605 for the Diagnosis of Non-IgE Mediated Cow's Milk Allergy in Children

APTITUDE
Start date: August 28, 2020
Phase: Phase 2
Study type: Interventional

Study to assess the diagnostic accuracy (sensitivity, specificity, positive and negative predictive value) of DBV1605 for the diagnosis of non-Immunoglobulin E (IgE) mediated cow's milk allergy (CMA) in children with symptoms suggestive of non-IgE mediated CMA.

NCT ID: NCT04330092 Completed - Cow's Milk Allergy Clinical Trials

Diagnosis of Cow's Milk Protein Allergy

Start date: May 1, 2020
Phase:
Study type: Observational

The study will assess the diagnosis of cow's milk protein allergy (CMPA) among infant and children in assiut university children hospital using skin prick test and specific serum IgE as well as their management.

NCT ID: NCT03462030 Completed - Cow's Milk Allergy Clinical Trials

Baked Milk Oral Immunotherapy for Cow's Milk Allergy

Start date: March 15, 2018
Phase: Phase 2
Study type: Interventional

The purpose of this study is to determine whether baked milk oral immunotherapy is safe in the treatment of cow's milk allergy.

NCT ID: NCT02779881 Completed - Cow's Milk Allergy Clinical Trials

Epigenetic Features of FoxP3 in Children With Cow's Milk Allergy

Start date: December 2012
Phase: N/A
Study type: Observational

Epigenetic mechanisms have been implicated in the pathogenesis of food allergy. The investigators previously demonstrated that tolerance acquisition in children with Immunoglobulin E- (IgE) mediated cow's milk allergy (CMA) is driven by epigenetic modulation of the Th1 and Th2 cytokine genes. A regulatory T cell (Treg) suppressive phenotype, characterized by stable expression of the transcription factor "Forkhead box Protein 3" (FoxP3), plays a pivotal role in food tolerance. FoxP3 mRNA expression is lower in children with atopic asthma or IgE-mediated food allergy than in healthy children. FoxP3 stable expression requires full CpG demethylation of its transcriptional regulatory regions, and, moreover, hypermethylation of the FoxP3 gene has been associated with reduced Treg function and allergy. DNA methylation is a biologically and chemically stable epigenetic modification that locks in long-term gene expression patterns. The demethylation status of FoxP3 at a highly conserved region within the Treg-specific-demethylated-region (TSDR), a CpG-rich, located on the 2nd conserved non-coding sequence of FoxP3 (CNS2), is restricted to Tregs. Transcriptional activity of the TSDR is essentially determined by its methylation status : it is completely inactive in its methylated state, but when the TSDR is demethylated, transcription factors such as Ets-1 and Creb can bind to the TSDR. TSDR demethylated and open chromatin conformation in the Foxp3 locus leads to stable phenotype differentiated Foxp3+ Treg. FoxP3 TSDR demethylation in peripheral blood mononuclear cells (PBMCs) has been associated with reduced atopic sensitization and asthma in children. Epigenetic regulation of antigen-induced T-cell subsets may predict a state of immune tolerance in food allergy. Indeed, DNA methylation of the FoxP3 gene in Tregs decreased during oral tolerance acquisition in patients with peanut allergy undergoing oral immunotherapy. The aim of this study was to evaluate further the epigenetic regulation of FoxP3 gene in children with IgE-mediated CMA.

NCT ID: NCT02738060 Completed - Cow's Milk Allergy Clinical Trials

The Effect of Baked Milk on Cow's Milk Allergy

Start date: September 2015
Phase: Phase 2
Study type: Interventional

To investigate the effect of baked milk in immunotherapy of cow's milk allergy.