Randomized Placebo-controlled Study of L. Reuteri NCIMB 30351 in GI Functional Disorders and Food Allergy in Newborns
This study is a randomized, placebo-controlled, single-masked (blinded), post-marketing clinical study of a drug Lactobacillus Reuteri NCIMB 30351 drops in functional disorders of gastrointestinal tract and skin symptoms of food allergies in children between the ages of one and four months inclusive. The aim of the study is to assess clinical effects of probiotics Lactobacillus Reuteri NCIMB 30351 drops on the symptoms of infantile colic, constipation, diarrhea, gastroesophageal reflux, atopic dermatitis/eczema in full-term newborns during the first months of life, laboratory parameters of microbiome will also be assessed. ...
Relevance of Sensitization to Legumes in Children Allergic to Peanut
The objectives of this study are to determine in children allergic to peanut (i) the prevalence of sensitization to other legumes, (ii) the prevalence of allergy to each legume in patients who are sensitized to it (iii ) the severity of the allergy to legumes other than peanut
Safety and Pharmacokinetics of Orodispersible BT-11 in Active Eosinophilic Esophagitis
The proposed Phase 1b study design is a randomized, placebo-controlled, double-blind, study to evaluate the safety and pharmacokinetics of oral BT-11 in active eosinophilic esophagitis. The primary and secondary objectives of this study is to establish safety and pharmacokinetics of orodispersible BT-11 in active eosinophilic esophagitis (EoE). The exploratory objectives of this study will include effects on disease activity measured by symptoms, endoscopy, histology and biomarkers, health-related quality of life, pharmacokinetics, and safety.
Serum Esnophilic Cationic Protein Level as Diagnostic Marker in Cow Milk Protein Allergy Infants
Characterize the degree of the activation of serum eosinophilc cationic protein (sECP) by measuring its level and establishing whether it is a useful parameter in monitoring oral cow's milk allergy Measure the MPV and NLR levels in infants with CMPA and to determine the suitability of these parameters as biomarkers in diagnosis of CMPA.
STEP-IT-UP - Peanut Allergy Study for Infants
Multicenter randomized (1:1) trial of strict avoidance versus sub-threshold dietary introduction of peanut in peanut allergic infants 4-14 months of age who react at a minimum cumulative dose of at least 430 mg of peanut protein at initial oral food challenge (OFC) for 12 months, followed by cross-over to sub-threshold dietary introduction of peanut in those randomized initially to avoidance.
Study of the Role of Hemostasis in Perioperative Anaphylaxis
Anaphylaxis is a severe and life-threatening complication during the perioperative period. Perioperative anaphylaxis is still associated with a significant mortality despite quick and efficient management using epinephrine, the mainstay of acute treatment. Experimental data and few case reports are suggesting that hemostasis, and more precisely platelets, could play a role in anaphylaxis. Our main hypothesis is that activation of the hemostatic system contributes to the severity of the reaction
The Effect of Early Childhood Cow's Milk Allergy Elimination Diet on Eating Behaviors, Nutrition, and Growth Status
Cow's milk allergy (CMA) is the most common Food Allergy (FA) in children, and the essential strategy in prevention is avoiding the allergens that may cause potentially life-threatening reactions. The primary developmental task of early childhood is the creation of healthy eating habits. The diagnosis of FA in this period can lead to permanent changes in the life of the child and her family. In early childhood, parents are often responsible for all aspects of FA management because children are too young to understand the complexity of avoiding allergens. Children often do not have the skills to implement FA management. Parents are...
An Extension Study of Lirentelimab in Eosinophilic Gastritis and/or Eosinophilic Duodenitis (Formerly Referred to as Eosinophilic Gastroenteritis)
This is a Phase 3, open-label, extension study to assess the long term efficacy and safety of lirentelimab given monthly.
Boiled Peanut Oral Immunotherapy
Prospective Phase 1 clinical trial providing proof of concept data on boiled peanut oral immunotherapy (OIT) for the treatment of peanut allergy in children. The investigators hypothesize that the proportion of subjects successfully desensitized with boiled peanut OIT is greater than the theoretical placebo rate of 20%.
Follow-up of the EPITOPE Study to Evaluate Long-term Efficacy and Safety of DBV712 in Young Children
Open-label, follow-up study for subjects who completed the EPITOPE study.