Health Condition 1: L509- Urticaria, unspecified
Conditions
Interventions
Intervention1: Lactogut: Each gelatin capsule contains a proprietary probiotic blend of 5 billion CFU containing, Bacillus coagulans unique IS-2, Lactobacillus rhamnosus UBLR-58, Bifidobacterium longu
Sponsors
Velbiom Probiotics
Centre for Interdisciplinary Research D Y Patil University Navi Mumbai
Eligibility
Inclusion criteria
Inclusion criteria: 1. Male and female volunteers of above 18 years of age or older with a clinical history of CSU lasting more than 6 weeks and hives more than 3 days in a week will be enrolled 2. Subjects must participate fully and be willing to comply with the procedures of the protocol. 3. The ability of a subject to understand and provide voluntary, written, informed consent to participate in the study. 4. Subjects agree to not substantially change diet, medications, or exercise routine.
Exclusion criteria
Exclusion criteria: 1. Patients using probiotic supplements during the past 4 weeks, before the screening. 2. Patients who are deemed to be uncooperative. 3. Pregnant or lactating women. 4. Subjects with a primary or acquired immunodeficiency, including HIV seropositivity. 5. Subjects receiving or planning to receive an investigational new drug (IND) agent, ultraviolet light therapy, monoclonal antibodies, or systemic immunosuppressants. 6. Use of topical or oral complementary and alternative (CAM) agents within 4 weeks of initiation of treatment. 7. Hypersensitivity to any components contained in the probiotic capsules/sachets. 8. Individuals who are cognitively impaired and/or who are unable to give informed consent. 9. Patients with significant concomitant illness (e.g. malignancies or psychiatric illness, hepatic, endocrine, or other major systemic diseases) will be excluded 10. Any other condition which in the Investigator’s opinion may adversely affect the subject’s ability to complete the study or its measures or which may pose a significant risk to the subject.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the ability of Lactogut to provide clinical & subjective relief from CSU after 12 weeks of treatment & or administration of the therapeutic agent under considerationTimepoint: At baseline 4 weeks 8 weeks & 12 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| To compare & evaluate the change in urticaria activity scores and urticaria control test from baseline to the end of 12 weeks of treatment of the therapeutic agent under considerationTimepoint: At baseline 4 weeks 8 weeks & 12 weeks | — |
Countries
India
Contacts
Public ContactDr Atul Deshmukh
D Y Patil University Navi Mumbai
Outcome results
None listed