Rheumatoid arthritis
Conditions
Interventions
Control:Take placebo
CCFM1078:Take CCFM1078
CCFM1074:Take CCFM1074
Sponsors
Wuxi No.2 People’s Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: Inclusion criteria a) According to the above diagnostic criteria, it meets the diagnosis of rheumatoid arthritis; b) 18 years = age = 75 years, the ratio of male and female is about 1:1; c) Early and middle stage of disease; d) Good compliance, able to comply with the requirements of clinical trials; e) The subject or guardian has signed the informed consent form; f) The patients filled in the written informed consent form, the basic situation questionnaire (Attached Table 1), the dietary structure and living condition questionnaire (Attached Table 2), and the health assessment questionnaire for patients with rheumatoid arthritis (Attached Table 3), and promised to cooperate with the study during the whole trial period; g) Before treatment, blood, urine, stool routine, liver and kidney function tests were within the normal range.
Exclusion criteria
Exclusion criteria: Exclusion criteria If patients meet one of the following exclusion criteria, they cannot participate in the study. Those who cannot be distinguished from rheumatoid arthritis, osteoarthritis and other diseases; Combined with other types of immune system diseases (systemic lupus erythematosus, Graves disease, psoriasis, etc.); Received treatment with biologically targeted drugs in the past 3 months; He has performed major abdominal surgery, especially intestinal surgery. Any abnormal physical condition or medical condition that affects the gastrointestinal tract or the use of experimental probiotics. Use drugs related to digestive tract diseases within two weeks, such as anti-spasmodic drugs, laxatives, anti-diarrhea drugs and other drugs that have an impact on intestinal peristalsis. ? At present or in the near future (within 1 month), use microecological agents, dietary supplements or Chinese herbal medicine to help digestion, or take large doses of vitamins or minerals. ? Take probiotics products in the near future (1 month) or take yogurt and probiotics drinks for a long time. ? Currently or recently (1 month) or long-term use of antibiotics or insulin. ? Allergic or lactose intolerant to the ingredients of experimental probiotic products. ? In the near future (within one month), there are significant changes in eating habits, such as starting to eat a diet rich in fiber. ? For women, they are pregnant, breastfeeding or hoping to be pregnant. ? Have convulsive symptoms or a history of mental illness. ? Other clinical studies are currently or in the near future (within 1 month). ? The researcher is unwilling or unable to provide a written informed consent to participate in the study after informing the researcher of the purpose, process and possible risks.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Anti-CCP antibody;Rheumatoid factor;C-reactive protein;Erythrocyte sedimentation rate;Faces 16S rDNA sequence; | — |
Countries
China
Contacts
Public ContactGuoxun Shi
Wuxi Second People's Hospital
Outcome results
None listed