Clinical trial of Biotherapi®, a probiotic supplement, as an additional therapy in the treatment of rheumatoid arthritis

Not Applicable

Completed

• Conditions: Rheumatoid arthritis; Musculoskeletal Diseases

• Registration Number: ISRCTN79856269
• Lead Sponsor: Yashoda Hospitals

Brief Summary

2020 Results article in https://www.indianjrheumatol.com/preprintarticle.asp?id=321200 (added 22/07/2021)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2019-07-21
• Study Start: 2020-10-02
• Last Update Posted: 2 August 2021

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 250

Inclusion Criteria

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)

Exclusion Criteria

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Disease Activity Score-28-Erythrocyte Sedimentation rate (DAS-28-ESR) measured by blood test at baseline, day 45, and day 90

Secondary Outcome Measures

Name	Time	Method
<br> At baseline, day 45, and day 90:<br> Symptoms of RA measured using:<br> 1. Clinical disease activity index (CDAI)<br> 2. Tender joint count (TJC)<br> 3. Swollen joint count (SJC)<br> 4. Patient general assessment score<br> 5. Physician Global Assessment of Disease Activity Score<br> 6. General health measured using the Health assessment questionnaire (HAQ) score<br>