Early Phase 1 N=25 Milk Oral Immunotherapy in Children to Treat Food Allergy
Milk Hypersensitivity
Primary: Number of Subjects Who Completed Desensitization Protocol — 6; 12 participants
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Completed trials with posted results — search by concept, filter by the parameters that matter at the bedside.
Phase 2 N=77 OIT and Xolair® (Omalizumab) in Cow's Milk Allergy
Milk Allergy
Primary: Percentage of Subjects in the Xolair® (Omalizumab) Group vs. Placebo Group Developing Clinical Tolerance to Milk — 46.4; 34.5 Percent of participants — p=0.42
Phase 2 N=20 A Randomized, Double-Blind, Placebo-Controlled Study of Oral Milk Immunotherapy for Cow's Milk Allergy
Milk Hypersensitivity
Primary: The Median Milk Threshold Dose Inducing a Reaction — 40; 40; 5100; 0 miligrams
N/A N=40 Study to Assess Hypoallergenicity of a New Amino-acid Based Infant Formula in Children With Cow's Milk Allergy
Cow's Milk Allergy
Primary: Hypoallergenicity as Assessed by Reaction to Amino-acid Based Infant Formula — 0; 0; 0; 30 Participants
Phase 2 N=30 The Safety and Efficacy of Sublingual/Oral Immunotherapy for the Treatment of Milk Protein Allergy
Milk Allergy
Primary: Change in CM-specific Immunogloblin E (IgE) — 0.8; -13.5; -9.4 kUa/L
Phase 2 N=170 Study of Milk Allergy and Tolerance in Children
Food Hypersensitivity · Milk Hypersensitivity
Primary: Number of Participants With a Positive Progression in Tolerance of Baked Milk and Ultimately Unheated Milk in Dose Escalation Sub-arm Compared to Maintenance Sub-arm…
Phase 2 N=30 Baked Milk Oral Immunotherapy for Cow's Milk Allergy
Cow's Milk Allergy
Primary: Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v4.0 — 15; 11 Participants
Phase 2 N=198 Efficacy and Safety of Viaskin Milk in Children With IgE-Mediated Cow's Milk Allergy
Food Allergy
Primary: Percentage (%) of Subjects Who Are Treatment Responders After 12 Months of EPIT Treatment. — 36.7; 49.0; 36.2; 30.2 percent of participants
N/A N=30 The Effect of Per Oral Immunotherapy in Severe Milk, Peanut and Egg Allergy in Adults
Food Allergy
Primary: Desensitisation — 7; 5; 2 Participants
N/A N=23 The Effect of Per Oral Immunotherapy in Severe IgE Mediated Egg, Milk, and Nut Allergy in Adults
Food Allergy
Primary: Number of the Patients That Achieve Higher Tolerance of Allergen With Immunotherapy — 6; 4; 3 participants
N/A N=22 Cold Milk for Dysphagia in Preterm Infants
Dysphagia of Newborn
Primary: Percentage of Infants With Improvement of Dysphagia — 58 Percentage of patients
Phase 2 N=20 Milk Patch for Eosinophilic Esophagitis
Eosinophilic Esophagitis · Milk Allergy
Primary: Change in Maximum Esophageal Eosinophil Count From Baseline to End of Double-blind Treatment. (Intent to Treat Population) — -10.8; -24.2 Eosinophils (Eos)/high power…
N/A N=30 Alleviation Of Metabolic Endotoxemia In Adults With Metabolic Syndrome With Milk Fat Globule Membrane
Metabolic Syndrome · Metabolic Endotoxemia
Primary: Serum Endotoxin — 32.5; 30.6 EU/ml
N/A N=24 Oral Immunotherapy for Peanut and Mammalian Meat Allergies
Food Hypersensitivity
Primary: The Level of Allergen Consumed Post-oral Immunotherapy — 6; 300 milligrams
N/A N=17 Dietetic Efficacy of Mare's Milk for Patients With Chronic Inflammatory Bowel Diseases
Ulcerative Colitis · Crohns Disease
Primary: Score of Crohn´s Disease and/or Ulcerative Colitis — 58; 1.8; 43; 1.2 units on a scale
Phase 3 N=483 Donor Milk vs. Formula in Extremely Low Birth Weight (ELBW) Infants
Infant, Newborn · Infant, Small for Gestational Age · Infant, Extremely Low Birth Weight
Primary: Bayley Scales of Infant Development (BSID) Cognitive Composite Score — 80.7; 81.1 Score on a scale
Phase 4 N=20 INF108F in Infants With Food Protein Induced Proctocolitis
Infant Development · Gut Microbiome · Food Protein Induced Allergic Proctocolitis
Primary: Changes to Gut Microbiome Composition — 42.816; -12.413 Change in %B.infantis reads (Day 28-BL) — p=0.154
N/A N=28 HYBRID: Hydrogen Breath Test in Lactose Digestion
Lactose Intolerance
Primary: Log of First Postprandial Peak Change of Hydrogen Concentration — 1.21; 1.10; 3.38; 3.59 log(ppm) — p=0.0801
N/A N=14 Multisensory Early Oral Administration of Human Milk in Preterm Infants
Infant Development · Stress
Primary: Feasibility of Intervention — 0; 7 Participants
N/A N=99 Effect of Colostrum on Mucosal Immunity in Very Low Birth Weight (VLBWs) Premature Infants
Prematurity
Primary: Concentration of APPs Before Oral Priming — 17; 22; 35; 42 femtomole (fmol)
N/A N=10 Novel Blood Test to Predict Safe Foods for Infants and Toddlers With Food Protein-induced Enterocolitis Syndrome (FPIES)
Food Protein-Induced Enterocolitis Syndrome · Allergies · Pediatric Disorder
Primary: Negative Predictive Value (NPV), Defined as the Percentage of Test-predicted Safe Foods That Are Actually Safe Foods. — 98.5; 73.16 percentage — p=<0.0001
Phase 2 N=15 Metformin to Augment Low Milk Supply (MALMS) Study
Low Milk Supply · Pre-diabetes · Insulin Resistance
Primary: Peak Change in Milk Output — 8; -58 milliliters
Phase 3 N=180 Omalizumab as Monotherapy and as Adjunct Therapy to Multi-Allergen OIT in Food Allergic Participants
Peanut Allergy · Multi-food Allergy
Primary: Number of Participants by Stage 1 Treatment Assignment, Omalizumab Versus Placebo, Who Successfully Consume a Single Dose of ≥600 mg of Peanut Protein Without…
Phase 2 N=75 Peanut Epicutaneous Phase II Immunotherapy Clinical Trial
Peanut Hypersensitivity · Food Hypersensitivity · Hypersensitivity
Primary: Percentage of Subjects With a Successful Treatment Response — 12.0; 45.8; 48.0 percentage of participants — p=0.005
N/A N=36 Antihypertensive Effect of Fermented Milk With Lactococcus Lactis on Prehypertensive Subjects
Hypertension
Primary: Systolic Blood Pressure Measurements — 131.8; 134.3; 122.1; 127.4 mmHg — p=<0.05
N/A N=52 Milk in Life Conditions (MiLC): Bacterial Composition of Human Milk Pumped and Stored in "Real-Life" Conditions
Human Milk Microbiome · Bacterial Growth
Primary: Bacterial Community Richness — 64.2; 58.9; 64.0; 60.8 Observed taxa — p=0.9
Phase 1 N=27 CampETEC Hyperimmune Bovine Colostrum (HBC)
Healthy Volunteer
Primary: Incidence of Adverse Events — 1; 1; 0; 1 events
N/A N=21 Donor Human Milk in Neonatal Abstinence Syndrome
Neonatal Abstinence Syndrome
Primary: Percentage of Infants Achieving a GI Subscore >2 Over the Study Period — 39; 61 Percentage of participants — p=0.001
Phase 2 N=60 Multi Immunotherapy to Test Tolerance and Xolair
Food Allergy
Primary: The Number of Participants Able to Tolerate an Oral Food Challenge to 2,000 mg at Least of 2 Allergens at Week 36 (i.e. the End of the Randomized Withdrawal/Tolerance…
Phase 2 N=36 Peanut Reactivity Reduced by Oral Tolerance in an Anti-IgE Clinical Trial
Peanut Allergy · Food Allergy
Primary: Tolerance of 2000 mg 6 Weeks After Last Dose of Omalizumab/Placebo — 23; 1 Participants