None listed
Conditions
Interventions
Group 1 Type of group
New Hypoallergenic Carmine is administered
Group name:Group 7 Type of group
Saline Water is administered
Sponsors
CHR. HANSEN, A/S,
Eligibility
Sex/Gender
All
Age
20 Years to 60 Years
Inclusion criteria
Inclusion criteria: • Age between 20 and 60 years, both included • People with pathophysiological problems compatible with respiratory allergy to cochineal-derived products, such as asthma or rhinoconjunctivitis, or at high risk of developing allergy to cochineal-derived products by exposure for several years. The same that will be obtained according to medical history. • body mass index between 20 and 35 kg / m2, both values included.
Exclusion criteria
Exclusion criteria: • Subjects with diseases or immune system disorders such as autoimmune or immunosuppressive diseases for any cause, even if they are not receiving drug treatment for them at the present time. • Subjects with relevant functional or structural abnormalities of the digestive system, such as malformations, angiodysplasia, active peptic ulcers or chronic inflammatory diseases. • Subjects with any infectious pathology that requires antimicrobial treatment at the time of inclusion. • Subjects who receive any type of treatment that modifies the immune response, such as immunosuppressants, corticosteroids, etc. • Subjects with celiac disease. • Subjects with debilitating pathologies such as diabetes and malignancies. • Subjects with a poor state of hydration and nutrition. • Subjects with important conditions in normal hematological and biochemical parameters. • Subjects with obvious and documented current alcoholism. • Subjects in which poor collaboration is foreseen or, in the opinion of the researcher, have difficulties to follow the development of the trial. • Subject women who are pregnant or suspected of being pregnant.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:By recording adverse events during the study. Measure:Allergenicity to Carmine and its Derivatives Timepoints:During the study | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:Measurement of Skin Puncture Tests (5 extracts and 2 controls): The following products will be used • New Hypoallergenic Carmine (allergenic carmine product containing peptide, not synthetic, that is to say of natural origin), • Protein Free Carmine (based on carminic acid, not synthetic, that is to say of natural origin) • Commercial Carmine, • Cochineal Extract, • Commercial Carmine Acid, • Histamine (positive control) and • Saline Water (negative control). Measure:Variation in Skin Puncture Tests Timepoints:During the study ; Outcome name:Patch test (5 extracts and 1 control): The following products will be used m New Hypoallergenic Carmine (allergenic carmine product containing peptide, non-synthetic, that is naturally occurring), • Protein Free Carmine (based on carminic acid, not synthetic, that is to say of natural origin) • Commercial Carmine, • Cochineal Extract, • Commercial Carmine Acid and • Saline Water (negative control). Measure:Patch Test Variation Timepoints:During the study | — |
Contacts
Public ContactRAUL JAVIER YEPEZ
PERUVIAN CLINICAL RESEARCH S.A.C
Outcome results
None listed