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 sites250 target enrollmentOctober 2, 2020

Overview

Registry

who.int

Start Date

October 2, 2020

End Date

July 21, 2019

Last Updated

4 years ago

Study Type

Interventional

Sex

All

Sponsor

Yashoda Hospitals

•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