Chronic Spontaneous Urticaria (CSU)
Conditions
Brief summary
A Prospective Clinical Study on the Efficacy and Safety of Bacterial Lysate (OM-85) Combined with Antihistamines in the Treatment of Chronic Spontaneous Urticaria (CSU): A Single-Centre, Observational, Cohort Study
Interventions
None listed
Sponsors
The Fourth Affiliated Hospital of Zhejiang University School of Medicine
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
1. The participants were fully informed of the purpose, procedure and risks of the study and voluntarily signed the informed consent form. 2. Aged 18 to 65 (inclusive), no gender restrictions. 3. Meets the CSU diagnostic criteria, with a disease duration of ≥6 weeks. 4. Antihistamine resistance: Regular use of a standard dose (as recommended in the package leaflet) of a second-generation H1 antihistamine (e.g. desloratadine 5 mg, levocetirizine 5 mg, etc.) for at least 2 weeks prior to screening, but with symptoms still not effectively controlled. Defined as: a UAS7 score of ≥7 within 7 days prior to the screening visit (V1) and baseline visit (V2). 5. Agree to maintain the type and dose of the baseline antihistamine throughout the trial. 6. Agree not to consume any products that may significantly affect the gut microbiota during the trial (such as yoghurt containing probiotics, or probiotic/prebiotic supplements). 7. At the baseline visit, the treatment regimen was clearly defined, and exposure status (OM-85 exposure group or non-exposure group) could be determined based on actual prescriptions and medication records.
Exclusion criteria
1. Special types of urticaria: These primarily include physical urticaria (such as artificial urticaria, cold contact urticaria and cholinergic urticaria), urticarial vasculitis, and angioedema caused by hereditary or acquired C1 esterase inhibitor deficiency; 2. Systemic use of glucocorticoids (oral or injectable) within the four weeks prior to screening; 3. Exclude patients who have used immunosuppressants (such as cyclosporine, methotrexate, or Tripterygium wilfordii) within the previous four weeks; 4. Exclude patients who have used biologics (such as omazulimab, dupilumab, etc.) within the previous three months; 5. Exclude those who have used bacterial lysates (such as Panfuxu or Pidomod) or received vaccinations within the past three months; 6. Key
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| UAS7 score at week 12 of treatment (90 days) | From baseline to weeks 4, 8, and 12 | Assessed using the 7-day Urticaria Activity Score (UAS7)，score is calculated between 0 (best score possible) and 42 (worstscore possible), compared with baseline |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of subjects with UAS7 ≤ 6 at week 12 of treatment (disease well controlled) | Week 12 (90 days) | Assessed using the 7-day Urticaria Activity Score (UAS7)，score is calculated between 0 (best score possible) and 42 (worstscore possible) |
| Changes in the CU-Q2oL score | From baseline to week 12 | Assessed using the Chronic Urticaria Quality of Life Questionnaire (CU-Q2oL)，score is calculated between 0 (best score possible) and 92 (worst score possible) |
| Proportion of subjects with UCT ≥ 12 at week 12 of treatment | From baseline to weeks 4, 8, and 12 | Assessment using the Urticaria Control Test (UCT), score is calculated between 0 (worst score possible) and 16 (best score possible). A UCT score of 12 or higher indicates that chronic urticaria is well controlled |
Countries
China
Contacts
CONTACTLiu
Outcome results
None listed