Ankylosing spondylitis
Conditions
Interventions
Control group:Placebo
Sponsors
Weihai Municipal Hospital of Shandong
Eligibility
Sex/Gender
All
Age
18 Years to 45 Years
Inclusion criteria
Inclusion criteria: 1. men or women, aged 18 and -45, need to ensure that non pregnant women can be included in the non pregnant and non lactation periods during the reproductive period; 2. at least 3 months before entering the group, it was in line with the 1984 New York AS standard and was diagnosed as AS; 3. AS was in the active period, that is, the Bath ankylosing spondylitis disease activity index (BASDAI) is greater than 4, the total pain score is more than 4 (using the visual analogue scale (VS) evaluation, unit 0-10cm), the morning stiffness is more than 30 minutes, and the erythrocyte sedimentation rate (ESR) and the C- reactive protein (CRP) are higher than the normal value; 4. did not take NSAIDs drugs before taking part in the group, or had taken NSAIDs but had been discontinued for at least 2 weeks; 5. no biological agent or glucocorticoid or sulfasalazine has been used or used for at least 3 months; 6. had received methotrexate, leflunomide, thalidomide, or hydroxychloroquine for at least 3 months before entering the group, and did not appear to be due to the improvement of the severe side effects of the anti rheumatic drug (DMARDs), especially no gastrointestinal reaction, and at least 4 weeks before the entry of the group; 7. no antibiotics, gastrointestinal motility drugs, probiotics or microecological active agents (such as yogurt) were used in the 1 months before treatment; 8. there is no history of major organ involvement, such as kidney, pancreas, gastrointestinal diseases, etc.; 9. there was no history of infectious gastrointestinal diseases such as diarrhoea or dysentery in the first 1 months; 10. no gastrointestinal surgery in the near future; 11. the drug compliance is good and can cooperate with the clinical research.
Exclusion criteria
Exclusion criteria: 1. stable patients; 2. the spine is completely rigid; 3. nearly 3 months have used or intended to use any biological agent or glucocorticoid or sulfasalazine in the near future; 4. antibiotics, gastrointestinal motility drugs, probiotics or microecological active agents (such as yogurt) were used within 1 months before treatment; 5. there is a history of major organ involvement, such as chronic renal failure, nephritis, pancreatitis, liver disease, gastric ulcer and so on; 6. patients with malignant tumors, especially those with digestive tract cancer; 7. there was a history of infectious gastrointestinal diseases such as diarrhoea and dysentery in the first 1 months, and diarrhea related to ankylosing spondylitis was not in this area; 8. recent gastrointestinal surgery; 9. patients with poor drug compliance and incompatibility with patients are unwilling to accept a randomized, double-blind, controlled trial; 10. pregnant women, breast-feeding women; 11. at the same time, the patients received other clinical trials; 12. allergic reaction to the sample or obvious gastrointestinal symptoms such as intolerance; 13. patients diagnosed with HIV / AIDS or liver diseases; 15. patients who rely on the control of drugs or / and alcohol; 16. patients who refused to sign the informed consent form; 17. patients who took antibiotics during the follow-up period; 18. during the follow-up period, patients with irregular eating habits and larger changes were found; 19. illiterates and deaf mutes can not evaluate their own pain receptors.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Bath ankylosing spondylitis function index;Bath disease activity index of ankylosing spondylitis;Bath ankylosing spondylitis measurement index;Attachment index of University of California (UCSF), San Francisco; | — |
Countries
China
Contacts
Public ContactJian Zhang
Weihai Municipal Hospital of Shandong
Outcome results
None listed