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

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.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN79856269

Enrollment

250

Registered

2020-10-02

Start date

2018-03-05

Completion date

Unknown

Last updated

2021-08-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rheumatoid arthritis Musculoskeletal Diseases Rheumatoid arthritis

Interventions

Patients with rheumatoid arthritis were randomized 1:1 into two groups. Patients in the intervention group received adjunctive probiotic supplement (capsules) for rheumatoid arthritis

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

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

Secondary

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

Countries

India

Contacts

Public ContactArindam Roy

doctor.arindam@yahoo.com+91 9849279830

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026