Skip to content

Preliminary clinical study of probiotics (Bacteroides fragility BF839) in the treatment of autoimmune diseases

Preliminary clinical study of probiotics (Bacteroides fragility BF839) in the treatment of autoimmune diseases

Status
Recruiting
Phases
Early Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR1900022383
Enrollment
Unknown
Registered
2019-04-09
Start date
2019-04-08
Completion date
Unknown
Last updated
2019-04-15

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

Conditions

autoimmune diseases

Interventions

Sponsors

The Second Affiliated Hospital of Guangzhou Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
6 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1 "Psoriasis" Inclusion Criteria: 1) Voluntary signing of informed consent; 2) Aged 6-65 years (including 6, 65 years old), gender is not limited; 3) Clinical and pathological diagnosis of patients with psoriasis vulgaris (diagnostic criteria refer to Zhao Jie, "Chinese Clinical Dermatology"): rash manifested as erythema, scales, membrane phenomenon, punctiform hemorrhage and main body extension Characteristics of symmetry distribution; punctate, small spherical, hairpin-like, ring-shaped blood vessels under a bright red background, diffusely distributed white scales; 4) PASI score = 12 points for mild to moderate psoriasis. 2 "Rheumatoid Arthritis" Inclusion Criteria: 1) Diagnosed as adult-onset RA with the American Association of Rheumatology 1987 RA classification criteria, and erythrocyte sedimentation rate or C-reactive protein = 1.4 times the upper limit of the normal range. 2) The drug treatment was not effective, and the DAS28 score was >2.6 points or more, and the drug treatment program did not change during the probiotic intervention. 3) Aged 18 to 65 years. 4) Voluntary signing of informed consent. 3 "Allergic Rhinitis" Inclusion Criteria: 1) Aged 18 to 60 years, both men and women. 2) In line with the clinical diagnostic criteria for perennial moderate to severe allergic rhinitis, the total symptom is divided into 6 or more, affecting the quality of life, and the course of disease is more than 2 years. 3) Allergen skin test or sIgE test positive, allergen nasal mucosa positive. 4) Willing to sign informed consent.

Exclusion criteria

Exclusion criteria: 1 "Psoriasis" Exclusion Criteria: 1) Taking hormones or immunosuppressive drugs within one month; 2) Received other clinical trials within one month; 3) Women who are pregnant or breast-feeding, or women of childbearing age who cannot take oral contraceptives during the trial; 4) Patients with other important organ function impairments or diseases such as heart, lung and kidney. 2 "Rheumatoid Arthritis" Exclusion Criteria: 1) Pregnant women, lactating women, or women of childbearing age who take oral contraceptives during the trial; 2) Received other clinical trials within one month; 3) The investigators confirmed that the subjects had current or recent severe, progressive, and uncontrolled heart, lung, liver, kidney and other vital organs and blood, endocrine system lesions and medical history; 4) Patients who are infected with herpes zoster or HIV infection at screening or who are at high risk of infection. 3 "Allergic Rhinitis" Exclusion Criteria: 1) Pregnant women, lactating women, or women of childbearing age who take oral contraceptives during the trial; 2) Patients with other diseases requiring long-term treatment with hormones and immunosuppressive drugs; 3) Patients with other important organ dysfunction or diseases such as heart, lung and kidney; 4) Hepatitis B, syphilis, AIDS and other chronic infections; 5) Received other clinical trials within one month.

Design outcomes

Primary

MeasureTime frame
PASI Score;DAS28;Nasal symptoms VAS score;Drug reduction rate;

Secondary

MeasureTime frame
weight;CD3+CD4+;CD3+;CD3+CD8+;CD19+B;NK;ESR;CRP;

Countries

China

Contacts

Public ContactDeng Yuhong
1376708863@qq.com+86 020-34152843

Outcome results

None listed

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