Ankylosing Spondylitis
Conditions
Interventions
Sponsors
The First Medical Center of Chinese PLA General Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1.Fulfilling the criteria for AS (1984 Modified New York criteria); 2.Aged 18 to 65 years; 3.Ineffective or intolerant of non-steroidal anti-inflammatory drugs (NSAIDs): ASDAS >= 2.1 with >= 1 NSAIDs in the maximal recommended dosage for more than 4 weeks or NSAIDs are contraindicated; 4.Accompanied by chronic diarrhea (including but not limited to inflammatory bowel disease, diarrhea predominant irritable bowel syndrome, functional diarrhea, etc.); 5.Voluntary signing of informed consent, able to comply with relevant procedures.
Exclusion criteria
Exclusion criteria: 1.Any rheumatic diseases other than AS, including but not limited to rheumatoid arthritis, systemic lupus erythematosus, etc; 2.Anyone who has used any TNF-alpha antagonist or other bDMARDs within the last 1 months; 3.Anyone who has used any immunosuppressant(cytoxan, methotrexate, mycophenolate mofetil, leflunomide, azathioprine, etc) or glucocorticoid within the last 3 months; 4.Patients who has received intra-articular injection, intramuscular injection or intravenous injection of corticosteroids within the last 1 months; 5.Patients who has received endoscopic examination(or bowel cleanse), barium meal examination, or drugs affecting the gut microbiota including antibiotics, PPIs, probiotics or prebiotics within the last 1 months; 6.Patients who has received spinal surgery or joint surgery within the last 6 months; 7.Patients with active infection(including mycobacterium infection, opportunistic infection, etc) within the last 3 months; 8.Women during pregnancy or lactation; 9.Severe concomitant diseases, including but not limited to: (1)Heart failure or history of heart failure, including asymptomatic heart failure; (2)Hepatitis B surface antigen, hepatitis C antibody or human immunodeficiency virus antibody is positive; (3)Active tuberculosis, or latent tuberculosis infection through chest X-ray examination or positive gamma interferon release test; (4)Lymphoproliferative diseases, including lymphoma or signs suggestive of lymphoproliferative diseases; (5)Malignant tumor or history of malignant tumor within 5 years. 10.Those with abnormal laboratory results: Total white blood cell count < 2500 cells/µL, platelets < 100000 cells/µL, neutrophils < 1500 cells/µL or hemoglobin < 8.5g/dl; 11.Patients who has participated in other clinical trials within the last 3 months or is participating in other clinical trials; 12.The investigator determined that the patients was not suitable for this trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Disease Activity score of ankylosing spondylitis; | — |
Secondary
| Measure | Time frame |
|---|---|
| Bath ankylosing spondylitis activity score;Bath ankylosing spondylitis function index;Bath ankylosing spondylitis index;Summary Form of health survey;Ankylosing spondylitis health index;Tendinitis score;Peripheral joint count;Gastrointestinal Symptom rating scale;Self-rating anxiety scale;Self-rating depression scale;Fecal microbiota;Fecal metabolites;Urinary Metabolites;Cytokines in peripheral blood; | — |
Countries
China
Contacts
Public ContactHuang Feng
The First Medical Center of Chinese PLA General Hospital
Outcome results
None listed