Clinical trials: Food Safety
Cow's Milk Allergy
Growth, Safety and Tolerance of a Rice Protein Hydrolysate Formula in Infants With Cow's Milk Protein Allergy
This is a multicenter, controlled, randomized, prospective, non-inferiority, double blind intervention trial to evaluate the children growth (at 6, 9 and 12 months) using a rice hydrolysed protein formula compared to an…
- Trial name
- GRITO-14 (NCT02405923)
- Testing
- HRF, eHF
- Where
- 5 sites in France, Spain
- Volunteers
- 117 people
- Sponsor
- Laboratorios Ordesa
Acne
ABSORICA in Patients With Severe Recalcitrant Nodular Acne
This is an uncontrolled, open-label study being conducted in approximately 200 healthy males, non-pregnant, non-nursing females, age 12 to 45 years, with severe recalcitrant nodular acne.
- Trial name
- NCT02457520
- Testing
- Isotretinoin
- Where
- United States
- Volunteers
- 201 people
- Sponsor
- Sun Pharmaceutical Industries Limited
Food Allergy
High and Low Dose Oral Sesame Immunotherapy - Comparison of Efficacy and Safety
In this trial the investigators aim to assess the effectiveness and safety of oral immunotherapy with sesame protein in high and low dose (300mg versus 1200mg) in children with sesame allergy.
- Trial name
- Sesame (NCT05158413)
- Testing
- High dose, Low dose
- Where
- Poland
- Volunteers
- 40 people
- Sponsor
- Medical University of Warsaw
Cow Milk Allergy
A Growth and Hypoallergenicity Study of a New Formula for Infants With Cow Milk Allergy
This study involves the use of 2 different Neocate formulas: a control formula called Neocate Infant and a test Neocate formula.
- Trial name
- CMA (NCT00664768)
- Testing
- Neocate Infant, new Neocate
- Where
- 22 sites in United States
- Volunteers
- 126 people
- Sponsor
- Nutricia North America
Allergy, Peanut Allergy
Safety Study of Viaskin® Peanut Patch in Peanut-Allergic Children 1 Through 3 Years of Age (COMFORT Toddlers)
The primary objective of this study is to assess the 6-month safety of DBV712 250 micrograms (mcg) in subjects 1 through 3 years of age with peanut allergy.
- Trial name
- NCT07003919
- Testing
- DBV712 250 mcg
- Where
- 91 sites in United States, Australia and 6 more
- Volunteers
- 480 people
- Sponsor
- DBV Technologies
Peanut Allergy
Epicutaneous Immunotherapy in Peanut Allergy in Children
This study aims at showing that Epicutaneous Immunotherapy with peanut proteins is safe and efficacious for desensitizing children with peanut allergy.
- Trial name
- ARACHILD (NCT01197053)
- Testing
- Epicutaneous Immunotherapy
- Where
- France
- Volunteers
- 60 people
- Sponsor
- Assistance Publique - Hôpitaux de Paris
Hypersensitivity, Milk
Early Oral Immunotherapy in Infants With Cow's Milk Protein Allergy
Cow's milk (CM) allergy is the most frequent food allergy in the first years of life, with prevalence rates estimated in the range of 2-3%.
- Trial name
- NCT03586388
- Testing
- Oral immunotherapy protocol
- Where
- Italy
- Volunteers
- 73 people
- Sponsor
- IRCCS Burlo Garofolo
Cow Milk Allergy
Growth, Safety and Tolerance of a Hydrolyzed Protein Infant Formula
This is a single arm, open label, multicenter intervention trial to evaluate growth parameters, cow's milk related symptoms, gastrointestinal tolerance and safety in infants with cow's milk allergy receiving a hydrolyzed protein…
- Trial name
- STORY (NCT05618704)
- Testing
- Hydrolyzed protein infant formula
- Where
- Poland
- Volunteers
- 69 people
- Sponsor
- Nutricia Research
Peanut Allergy
Study to Evaluate Dupilumab Monotherapy in Pediatric Patients With Peanut Allergy
The primary objective of the study is to assess the tolerability of peanut protein in pediatric patients (6-17 years old) treated with dupilumab monotherapy, in which tolerability is defined as the proportion of patients who…
- Trial name
- NCT03793608
- Testing
- Dupilumab
- Where
- 9 sites in United States, Canada
- Volunteers
- 25 people
- Sponsor
- Regeneron Pharmaceuticals
Peanut Allergy
Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of IGNX001
The goal of this randomized, double-blind, placebo-controlled, single ascending dose clinical trial is to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of IGNX001 in peanut-allergic adults and older…
- Trial name
- NCT06331728
- Testing
- IGNX001
- Where
- 4 sites in Australia
- Volunteers
- 32 people
- Sponsor
- IgGenix Australia Pty Ltd
Food Allergy, Wheat Hypersensitivity
A Study to Evaluate the Safety, Efficacy, Pharmacokinetic and Pharmacodynamic Characteristics of LP-003 Injection in Participants With Wheat Allergy
This is a multicenter, randomized, open-label Phase II clinical study to evaluate the safety, efficacy, pharmacokinetic (PK), pharmacodynamic (PD) and immunogenicity profiles of LP-003 injection in participants with Wheat…
- Trial name
- NCT07816432
- Testing
- LP-003 Injection
- Where
- China
- Volunteers
- 12 people
- Sponsor
- Longbio Pharma (Suzhou) Co., Ltd.
Prader-Willi Syndrome, Obesity
Double-Blind, Placebo Controlled, Phase 3 Trial of ZGN-440 (Beloranib) in Obese Subjects With Prader-Willi Syndrome
The purpose of this study is to evaluate efficacy and safety of ZGN-440 (beloranib) in obese adolescent and adult subjects with Prader-Willi Syndrome.
- Trial name
- bestPWS (NCT02179151)
- Testing
- ZGN-440 for Injectable Suspension
- Where
- 15 sites in United States
- Volunteers
- 108 people
- Sponsor
- Zafgen, Inc.
Milk Allergy, Anaphylaxis
Safety of Oral Immunotherapy for Cow's Milk Allergy in School-aged Children
The purpose of this study is to study the number of Participants with Adverse Events as a Measure of Safety and Tolerability.
- Trial name
- NCT01361347
- Testing
- milk
- Where
- Finland
- Volunteers
- 28 people
- Sponsor
- Tampere University Hospital
Food Allergy
Efficacy and Safety of Viaskin Milk in Children With IgE-Mediated Cow's Milk Allergy
The objectives of this study are to evaluate the safety and efficacy of Viaskin Milk after 12 months of epicutaneous immunotherapy (EPIT) treatment, for desensitizing IgE-mediated cow's milk allergic children and to assess the…
- Trial name
- MILES (NCT02223182)
- Testing
- Viaskin Milk 150 mcg, Viaskin Milk 300 mcg, Viaskin Milk 500 mcg
- Where
- 17 sites in United States, Canada
- Volunteers
- 198 people
- Sponsor
- DBV Technologies
Allergies Food Milk
Dupilumab and Milk OIT for the Treatment of Cow's Milk Allergy
This is a phase 2, multicenter, randomized, double-blind, parallel group, 2 arm study in approximately 40 subjects aged 4 to 50 years, inclusive, who are allergic to cow's milk.
- Trial name
- NCT04148352
- Testing
- Dupilumab
- Where
- 3 sites in United States
- Volunteers
- 33 people
- Sponsor
- Andrew J Long, PharmD
Growth Failure
Safety Study of Infant Formula With Partially Hydrolized Whey
The study will be a randomized, double-blind, prospective trial. Newborn infants (enrollment age 0-14 days) will be assigned randomly to receive one of two products, provided in identical packages except for the lid color.
- Trial name
- NCT00548106
- Testing
- partially hydrolyzed whey, Nan HA
- Where
- Israel
- Sponsor
- Soroka University Medical Center
Irritable Bowel Syndrome Characterized by Constipation
Food Supplement Physiomanna® Baby in Pediatric Patients
The primary objective is to assess the efficacy and safety of the Food Supplement Physiomanna® Baby in pediatric patients with a history of functional constipation The secondary objective of the trial is to evaluate the adherence…
- Trial name
- NCT02732743
- Testing
- Physiomanna® Baby
- Where
- Romania
- Volunteers
- 45 people
- Sponsor
- Iuppa Industriale Srl
Food Safety, Pregnancy Related
Evaluation of a Health Promotion Intervention on Food Safety in Women During Pregnancy
This is a comparative, observational study aiming to compare the diversity of the diet during pregnancy of women who have benefited from a health promotion intervention and who have not
- Conditions
- Food Safety, Pregnancy Related, Health Promotion
- Trial name
- NPTM2 (NCT06528535)
- Testing
- Health promotion intervention
- Where
- French Guiana
- Volunteers
- 200 people, healthy volunteers welcome
- Sponsor
- Centre Hospitalier de Cayenne
Obesity, Over-weight
An Efficacy, Safety, and Pharmacokinetics Study of Beloranib in Obese Subjects With Prader-Willi Syndrome
The purpose of this study is to evaluate the efficacy, safety, and pharmacokinetics for certain doses of beloranib in obese subjects with Prader-Willi Syndrome.
- Conditions
- Obesity, Over-weight, Prader-Willi Syndrome
- Trial name
- NCT01818921
- Testing
- ZGN-440 sterile diluent, 1.2 mg ZGN-440 for injectable suspension, 1.8 mg ZGN-440 for injectable suspension
- Where
- United States
- Volunteers
- 17 people
- Sponsor
- Zafgen, Inc.
Peanut Allergy
Oral Desensitization to Peanut in Peanut Allergic Children and Adults Using CPNA Peanut OIT Safety Follow-On Study
This is a multi-center, open-label, follow-on study to gather additional information on the safety and tolerability of oral desensitization with CPNA in the subjects who participated in ARC001.
- Trial name
- NCT02198664
- Testing
- AR101 - Peanut protein capsule
- Where
- 8 sites in United States
- Volunteers
- 47 people
- Sponsor
- Aimmune Therapeutics, Inc.