Clinical trials: Food Labeling
Functional Gastrointestinal Disorders, Functional Abdominal Pain
Effect of 35624® Alflorex® in Functional Gastrointestinal Disorders (FGIDs) in Children.
The aim of this study is to evaluate the effect of supplementation with Bifidobacterium longum 35624® Alflorex® on frequency and severity of symptoms of abdominal pain using an adapted Irritable Bowel Symptom Severity Scoring…
- Trial name
- NCT04922476
- Testing
- Alflorex®
- Where
- Chile
- Volunteers
- 65 people
- Sponsor
- PrecisionBiotics Group Ltd.
Peanut Allergy
Safety Study of Viaskin Peanut to Treat Peanut Allergy
This study evaluates the safety of Viaskin Peanut 250 µg in the treatment of peanut allergy in children from 4 to 11 years of age.
- Trial name
- REALISE (NCT02916446)
- Testing
- Viaskin Peanut 250 µg
- Where
- 32 sites in United States, Canada
- Volunteers
- 393 people
- Sponsor
- DBV Technologies
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
To Assess the Safety and Tolerabiltiy of an Amino Acid Composition in Subjects With Sickle Cell Disease, Anemia, Sickle Cell
To Assess Safety, Tolerability and Physiological Effects on Structure and Function of AXA4010 in Subjects With Sickle Cell Disease
This is an open-label study to understand the safety and tolerability of AXA4010, a novel composition of amino acids in adult and adolescent subjects with sickle cell disease over 12 weeks.
- Conditions
- To Assess the Safety and Tolerabiltiy of an Amino Acid Composition in Subjects With Sickle Cell Disease, Anemia, Sickle Cell, Sickle Cell Anemia, Sickle Cell Disorders
- Trial name
- NCT04134299
- Testing
- AXA4010
- Where
- 4 sites in United States
- Volunteers
- 9 people
- Sponsor
- Axcella Health, Inc
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
Peanut Allergy
Real World, Open Label, QOL Assessment of Peanut Immunotherapy AR101 in Children and Adolescents
To compare the HRQOL of AR101 characterized oral desensitization immunotherapy (CODIT™) in combination with standard of care (peanut avoidance, education) versus standard of care alone in peanut-allergic subjects aged 4 to 17…
- Trial name
- NCT03703791
- Testing
- AR101
- Where
- 11 sites in Spain
- Volunteers
- 1 people
- Sponsor
- Aimmune Therapeutics, Inc.
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.
Peanut Allergy
Longer-term Study of AR101 in Subjects Who Participated in a Prior AR101 Study (ARC008)
The purpose of this study is to assess AR101's safety, tolerability and efficacy over an extended dosing period.
- Trial name
- NCT03292484
- Testing
- AR101
- Where
- 93 sites in United States, Canada and 8 more
- Volunteers
- 911 people
- Sponsor
- Aimmune Therapeutics, Inc.
Healthy
A Two Part Study to Assess Safety, PK, PD, and Food Effect of Oral HTL0016878
Phase 1, first in human, two-part, single centre, placebo-controlled, single and multiple ascending dose trial in healthy younger and elderly adult subjects, with an open-label, randomised, crossover arms to assess the effect of…
- Trial name
- NCT03244228
- Testing
- HTL0016878
- Where
- United Kingdom
- Volunteers
- 120 people, healthy volunteers welcome
- Sponsor
- Nxera Pharma UK Limited
Peanut Allergy
Follow-up of the PEPITES Study to Evaluate Long-term Efficacy and Safety of Viaskin Peanut in Children
This is an open-label, follow-up study for subjects who completed the PEPITES study. Subjects will be offered enrollment in this follow-up study to receive Viaskin Peanut 250 μg for 2 additional years if previously on active…
- Trial name
- PEOPLE (NCT03013517)
- Testing
- Viaskin Peanut 250µg
- Where
- 31 sites in United States, Australia and 3 more
- Volunteers
- 300 people
- Sponsor
- DBV Technologies
Enteral Feeding
Nutritional Tolerance and Safety of a Tube Feeding Formula in Children
To assess the efficacy, tolerance, and safety of a pediatric enteral formula in children.
- Trial name
- NCT05838495
- Testing
- formulated liquid diet
- Where
- Canada
- Volunteers
- 27 people
- Sponsor
- Société des Produits Nestlé (SPN)
Transfusional Hemosiderosis
Palatability and Tolerability of Deferasirox Taken With Meals, With Different Liquids or Crushed and Added to Food
This single-arm, open-label, multi-center study enrolled 65 patients from approximately 20 centers. All patients who met the study criteria and were taking, beginning or resuming treatment with Deferasirox were allowed.
- Trial name
- NCT00845871
- Testing
- deferasirox:
- Where
- 23 sites in United States
- Volunteers
- 65 people
- Sponsor
- Novartis Pharmaceuticals
Peanut Allergy
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.
- Trial name
- EPOPEX (NCT03859700)
- Testing
- DBV712 250 mcg
- Where
- 26 sites in United States
- Volunteers
- 304 people
- Sponsor
- DBV Technologies
Biological Availability
Bioavailability of Omega-3 Food Supplement in Healthy Subjects
The study will evaluate the relative bioavailability of Pronovum PRF-037 and Pronovum PRF-041 with PronovaPure 150:150 EE EU and Eskimo-3 (500 mg omega-3 acid triglyceride containing 80 mg EPA and 50 mg DHA per gram oil) in…
- Trial name
- NCT02376608
- Testing
- Pronova Pure 150:500 EE EU, Pronovum PRF-037, Pronovum PRF-041
- Where
- United Kingdom
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Pronova BioPharma
Peanut Allergy
AR101 Real-World Open-Label Extension Study
This study is enrolling participants by invitation only. This is an open-label, safety extension study for subjects who participated in the ARC007 study.
- Trial name
- NCT03337542
- Testing
- AR101
- Where
- 60 sites in United States, Canada
- Volunteers
- 243 people
- Sponsor
- Aimmune Therapeutics, Inc.
Peanut Allergy
A Study to Assess the Biological Potency of Peanut Allergen Extract in Adolescent and Adult Peanut Allergic Subjects
The study aims to assess the biological potency of the In-House Reference Preparation (IHRP) of peanut allergens extract by a quantitative Skin Prick Test (SPT) method in peanut-allergic subjects.
- Trial name
- V712-103 (NCT03352726)
- Testing
- DBV712 IHRP
- Where
- 2 sites in United States
- Volunteers
- 27 people
- Sponsor
- DBV Technologies
Urea Cycle Disorders
Clinical Food Study to Evaluate the Effect of KB195 on Gut Nitrogen Metabolism in Patients With Urea Cycle Disorders
This clinical food study aims to explore the effect of KB195, a novel mixture of oligosaccharides, on the metabolism of nitrogen by the microbiome in patients with urea cycle disorders (UCDs).
- Trial name
- NCT03797131
- Testing
- KB195 (a novel mixture of oligosaccharides)
- Where
- Switzerland
- Volunteers
- 4 people
- Sponsor
- Kaleido Biosciences
Peanut Hypersensitivity
A Study of Xolair in Peanut-Allergic Subjects Previously Enrolled in Study Q2788g
This is a Phase IIb, multicenter, open-label study available to active (Xolair) and control (placebo) subjects who have completed their final visit (or early termination visit, if applicable) for Study Q2788g, who meet the…
- Trial name
- NCT00382148
- Testing
- omalizumab
- Volunteers
- 11 people
- Sponsor
- Genentech, Inc.
Food Allergy
Open-label Extension Study of ADP101
This is an open-label, safety extension study for participants who participated in the Harmony study (protocol ADP101-MA-01).
- Trial name
- NCT05243719
- Testing
- ADP101
- Where
- 14 sites in United States
- Volunteers
- 45 people
- Sponsor
- Alladapt Immunotherapeutics, Inc.
Peanut Allergy
Follow-up of the VIPES Study to Evaluate Efficacy and Safety of Viaskin Peanut in Adults and Children
The objectives of this open-label follow-up study for subjects who previously were randomized and have completed the VIPES study for the treatment of peanut allergy, are: To assess the efficacy of Viaskin Peanut after up to 36…
- Trial name
- OLFUS-VIPES (NCT01955109)
- Testing
- Viaskin Peanut 250 mcg
- Where
- 22 sites in United States, Canada and 2 more
- Volunteers
- 171 people
- Sponsor
- DBV Technologies