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Efficacy of bacteroides fragilis BF839 in the adjunct treatment of mild to moderate psoriasis vulgaris: a single-center, randomized, double-blind, parallel controlled clinical trial

Efficacy of bacteroides fragilis BF839 in the adjunct treatment of mild to moderate psoriasis vulgaris: a single-center, randomized, double-blind, parallel controlled clinical trial

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100054919
Enrollment
Unknown
Registered
2021-12-29
Start date
2022-01-01
Completion date
Unknown
Last updated
2022-12-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Psoriasis

Interventions

Sponsors

The Second Affiliated Hospital of Guangzhou Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Diagnosed as psoriasis vulgaris; 2. Mild to moderate psoriasis vulgaris, PASI = 18 years, female or male; 4. Female subjects of reproductive age maintained contraception during the trial through condoms, birth control pills, ligation or other contraception methods; 5. The patient is informed of the trial and signed the informed consent.

Exclusion criteria

Exclusion criteria: 1. Received biologicals treatment within 6 months; 2. Received systemic glucocorticoid or immunosuppressant treatment; 3. Patients with severe gastrointestinal diseases or chronic diarrhea; 4. Received systemic antibiotic treatment within one month; 5. Patients participated in other clinical trials within one month; 6. Pregnant women or breast feeding women; 7. Disagree to use Bacteroides fragilis BF839 treatment; 8. Patients are involving in other trials now or considered as unsuitable for the trial by the trial investigator.

Design outcomes

Primary

MeasureTime frame
PASI (Psoriasis Area and Severity Index);

Secondary

MeasureTime frame
NAPSI (Nail Psoriasis Severity Index);BSA (Body Surface Area);DLQI (Dermatology Life Quality Index));Stool intestinal flora examination;

Countries

China

Contacts

Public ContactYang Wenlin

The Second Affiliated Hospital of Guangzhou Medical University

yangwenlin@21cn.com+86 20 34152473

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026