A Prospective, Single-centre, Observational Cohort Study on the Efficacy and Safety of Bacterial … (NCT07557888) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
A Prospective, Single-centre, Observational Cohort Study on the Efficacy and Safety of Bacterial Lysate (OM-85) in Combination With Antihistamines for the Treatment of Chronic Spontaneous Urticaria (CSU)
China132 participantsStarted 2026-05-01
Plain-language 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
Who can participate
Age range18 Years – 65 Years
SexALL
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Inclusion criteria
✓. The participants were fully informed of the purpose, procedure and risks of the study and voluntarily signed the informed consent form.
✓. Aged 18 to 65 (inclusive), no gender restrictions.
✓. Meets the CSU diagnostic criteria, with a disease duration of ≥6 weeks.
✓. 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).
✓. Agree to maintain the type and dose of the baseline antihistamine throughout the trial.
✓. 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).
✓. 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
✕. 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;
✕. Systemic use of glucocorticoids (oral or injectable) within the four weeks prior to screening;
What they're measuring
1
UAS7 score at week 12 of treatment (90 days)
Timeframe: From baseline to weeks 4, 8, and 12
Trial details
NCT IDNCT07557888
SponsorThe Fourth Affiliated Hospital of Zhejiang University School of Medicine
✕. Exclude patients who have used immunosuppressants (such as cyclosporine, methotrexate, or Tripterygium wilfordii) within the previous four weeks;
✕. Exclude patients who have used biologics (such as omazulimab, dupilumab, etc.) within the previous three months;
✕. Exclude those who have used bacterial lysates (such as Panfuxu or Pidomod) or received vaccinations within the past three months;
✕. Key exclusion criteria for the microbiome study: use of oral or intravenous antibiotics within the four weeks prior to screening, or continuous use of probiotic supplements for more than one week.
✕. Patients with severe systemic autoimmune diseases (such as systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, etc.) may interfere with the assessment of immune mechanisms;
✕. A history of serious liver, kidney, heart, lung or blood disorders, or malignant tumours;