Chronic Spontaneous Urticaria (CSU)NCT07557888
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)
An observational study of Chronic Spontaneous Urticaria (CSU), run by The Fourth Affiliated Hospital of Zhejiang University School of Medicine at 1 site in China.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Chronic Spontaneous Urticaria (CSU)
- Type of treatment
- Pill or oral medicine
- How many people
- 132 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2026to 1 Jun 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The inclusion and exclusion criteria for the study participants are as set out above
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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;
- Individuals known to be allergic to bacterial lysates and their excipients.
- Special populations: pregnant or breastfeeding women, or participants of childbearing age who do not intend to use contraception during the trial.
- Other: Participants who have taken part in other clinical trials involving medicinal products within the past 30 days; or where the investigator considers that there is poor compliance, a mental health condition, or any other circumstance rendering the participant unsuitable for the trial.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
The Fourth Affiliated Hospital Zhejiang University School of Medicine
Yiwu, Zhejiang, 322000
Liu, 0579-89979999, 2197055@zju.edu.cn
About this study
Official title: 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
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
- Conditions
- Chronic Spontaneous Urticaria (CSU)
- Medical subject headings
- Chronic Urticaria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Exposure group | Bacterial lysate capsules + second-generation antihistamines (loratadine tablets, cetirizine hydrochloride tablets, levocetirizine hydrochloride tablets, ebastine tablets, olopatadine hydrochloride tablets, fexofenadine hydrochloride tablets) | |
| Non-exposure group | Second-generation antihistamines (loratadine tablets, cetirizine hydrochloride tablets, levocetirizine hydrochloride tablets, ebastine tablets, olopatadine hydrochloride tablets, fexofenadine hydrochloride tablets) |
What is being measured
The primary outcome is the main question the study is designed to answer.
UAS7 score at week 12 of treatment (90 days)
Assessed using the 7-day Urticaria Activity Score (UAS7)，score is calculated between 0 (best score possible) and 42 (worstscore possible), compared with baseline
Measured: From baseline to weeks 4, 8, and 12
Secondary outcomes (3)
Proportion of subjects with UAS7 ≤ 6 at week 12 of treatment (disease well controlled)
Assessed using the 7-day Urticaria Activity Score (UAS7)，score is calculated between 0 (best score possible) and 42 (worstscore possible)
Measured: Week 12 (90 days)
Changes in the CU-Q2oL score
Assessed using the Chronic Urticaria Quality of Life Questionnaire (CU-Q2oL)，score is calculated between 0 (best score possible) and 92 (worst score possible)
Measured: From baseline to week 12
Proportion of subjects with UCT ≥ 12 at week 12 of treatment
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
Measured: From baseline to weeks 4, 8, and 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2026
- Study start1 May 2026 (estimated)
- Primary completion1 Mar 2027 (estimated)
- Study completion1 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Spontaneous Urticaria (CSU)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 132 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Fourth Affiliated Hospital of Zhejiang University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07557888
- Sponsor's protocol ID
- KY-2026-081
- Status last verified
- May 2026
- First submitted
- 22 Apr 2026
- Last updated
- 7 May 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07557888
- Acronym / sponsor ID
- KY-2026-081
- Conditions
- Chronic Spontaneous Urticaria (CSU)
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 132 participants (estimated)
- Lead sponsor
- The Fourth Affiliated Hospital of Zhejiang University School of MedicineUniversity, hospital or other
- Study start
- 1 May 2026 (estimated)
- Primary completion
- 1 Mar 2027 (estimated)
- Study completion
- 1 Jun 2027 (estimated)
- First posted
- 30 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exposure group | – | –Bacterial lysate capsules + second-generation antihistamines (loratadine tablets, cetirizine hydrochloride tablets, levocetirizine hydrochloride tablets, ebastine tablets, olopatadine hydrochloride tablets, fexofenadine hydrochloride tablets) |
| Non-exposure group | – | –Second-generation antihistamines (loratadine tablets, cetirizine hydrochloride tablets, levocetirizine hydrochloride tablets, ebastine tablets, olopatadine hydrochloride tablets, fexofenadine hydrochloride tablets) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The inclusion and exclusion criteria for the study participants are as set out above
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (11 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
UAS7 score at week 12 of treatment (90 days)
Time frame: 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
3 secondary outcomes
Proportion of subjects with UAS7 ≤ 6 at week 12 of treatment (disease well controlled)
Time frame: Week 12 (90 days)
Changes in the CU-Q2oL score
Time frame: From baseline to week 12
Proportion of subjects with UCT ≥ 12 at week 12 of treatment
Time frame: From baseline to weeks 4, 8, and 12
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Spontaneous Urticaria (CSU), run by The Fourth Affiliated Hospital of Zhejiang University School of Medicine at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 7 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Liu (0579-89979999, 2197055@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
UAS7 score at week 12 of treatment (90 days) (time frame: From baseline to weeks 4, 8, and 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 May 2026.