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 range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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).
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
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
. 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;
. 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;