A prospective, randomized, single-centre, two-arm, open-label study to evaluate the efficacy of Biotherapi®, a two-strain Bacillus probiotic blend, as an adjunctive therapy in the treatment of rheumatoid arthritis.

Yashoda Hospitals0 个研究点目标入组 250 人开始时间: 2020年10月2日最近更新: 2021年8月2日

适应症

试验速览

•1. Between the age of 18 to 75
•2. Clinically diagnosed with RA (according to ACR 2010 criteria)
•3. Active disease defined by DAS28ESR >2.6
•4. On RA treatment for at least 3 months and are expected to stay on stable dose throughout the study duration (i.e ongoing
•medication and/or other therapy such as physiotherapy are permitted, except immunotherapy)

•1. Chronic renal failure/renal tubular acidosis
•2. Pancreatitis
•3. Inflammatory bowel disease or leaky gut
•4. Currently consuming Probiotics with refusal to have a 2 week washout period, known to have allergies to the study product
•5. Planned to have surgery during the time of the study
•6. Mental illness impairing ability to comply with study
•7. Women who are pregnant or plan to get pregnant during the study period, women who are breastfeeding
•8. Any illness that could impair their ability to comply with the study, or were enrolled in another study
•9. Exposure to >10mg/day of Prednisolone
•10. Plan to start with biological agents
•11. Subjects having arthritis other than Rheumatoid

发起方

Yashoda Hospitals