Clinical trial of Biotherapi®, a probiotic supplement, as an additional therapy in the treatment of rheumatoid arthritis
| ISRCTN | ISRCTN79856269 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN79856269 |
- Submission date
- 29/09/2020
- Registration date
- 02/10/2020
- Last edited
- 22/07/2021
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Musculoskeletal Diseases
Plain English summary of protocol
Background and study aims
Rheumatoid arthritis (RA) is a long-term condition that causes pain, swelling and stiffness in the joints. The condition usually affects the hands, feet and wrists.
Probiotics are live bacteria and yeasts that are good for you, especially your digestive system.
The use of probiotics to prevent or treat arthritis is unexplored but some studies have indicated the potential benefit. Oral treatment with probiotics has been shown to decrease the severity of arthritis symptoms.
Who can participate?
Adults aged 18 to 75, diagnosed with RA.
What does the study involve?
Participants will be randomly allocated to receive treatment as usual with or without probiotic supplement (capsules) for rheumatoid arthritis for 90 days.
What are the possible benefits and risks of participating?
There are no side effects or risk due to participation in this study.
Where is the study run from?
Yashoda Hospitals, Secunderabad (India)
When is the study starting and how long is it expected to run for?
August 2017 to July 2019
Who is funding the study?
Investigator-initiated and funded
Who is the main contact?
Dr Arindam Nandy Roy, doctor.arindam@yahoo.com
Contact information
Public
Yashoda Hospitals
Secunderabad
Hyderabad
500003
India
 ORCID ID |
0000-0003-2393-9689 |
|---|---|
| Phone | +91 9849279830 |
| doctor.arindam@yahoo.com |
Study information
| Study design | Single centre interventional randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | 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. |
| Study objectives | The purpose of the study is to evaluate the effects of BIOTHERAPI-® (Combination of Bacillus Subtilis 1972 and Bacillus Coagulans 1969) on disease activity and functional ability of RA patients when used in combination with pharmacological anti-rheumatic medications. |
| Ethics approval(s) | Approved 26/02/2018, Institutional Ethics Committee-YAMER (Yashoda Hospital, Behind Hari Hara Kala Bhavan, S.P.Road, Secunderabad –500 003, Telangana State, India; +91 (0)40-67778999 Extn: 8457; no email provided), ref: RP/02/2017 |
| Health condition(s) or problem(s) studied | Rheumatoid arthritis |
| Intervention | Patients with rheumatoid arthritis were randomized 1:1 into two groups. Patients in the intervention group received adjunctive probiotic supplement (capsules) for rheumatoid arthritis, and patients in the nonintervention group (n=125) received only the standard of care treatment. Every alternate patient received adjunctive probiotic as per protocol. Each probiotic capsule contained not less than (NLT) 5 billion colony-forming units (CFUs) of B. subtilis (SNZ 1972) and B. coagulans (SNZ 1969). The standard of care treatment consisted of methotrexate, hydroxychloroquine, sulphasalazine, leflunomide, and methylprednisolone. One capsule of the probiotic supplement was self-administered twice-daily for a period of 90 days (3 months). On-going medication and/or additional therapy such as physiotherapy were allowed. Patients were observed at two follow-up visits after randomization over the course of 90 days on days 45 and 90. |
| Intervention type | Supplement |
| Primary outcome measure | Disease Activity Score-28-Erythrocyte Sedimentation rate (DAS-28-ESR) measured by blood test at baseline, day 45, and day 90 |
| Secondary outcome measures | 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 |
| Overall study start date | 23/08/2017 |
| Completion date | 21/07/2019 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 250 |
| Total final enrolment | 250 |
| Key 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) |
| Key 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 |
| Date of first enrolment | 05/03/2018 |
| Date of final enrolment | 21/04/2019 |
Locations
Countries of recruitment
- India
Study participating centre
Behind Hari Hara Kala Bhavan
Alexander Road
Secunderabad
500003
India
Sponsor information
Hospital/treatment centre
Behind Hari Hara Kala Bhavan
Alexander Road
Secunderabad
Hyderabad
500003
India
| Phone | +91 9849279830 |
|---|---|
| secunderabad@yashoda.in |
Funders
Funder type
Other
No information available
Results and Publications
| Intention to publish date | 01/12/2021 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Other |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal. |
| IPD sharing plan | All data generated or analysed during this study will be included in the subsequent results publication |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol file | version V0 | 01/10/2020 | 08/10/2020 | No | No |
| Results article | 15/10/2020 | 22/07/2021 | Yes | No |
Additional files
- ISRCTN79856269_PROTOCOL_V0_01Oct2020.pdf
- Uploaded 08/10/2020
Editorial Notes
22/07/2021: Publication reference added.
08/07/2021: The intention to publish date has been changed from 01/12/2020 to 01/12/2021.
08/10/2020: Uploaded protocol Version 0, 1 October 2020 (not peer reviewed).
01/10/2020: Trial’s existence confirmed by Institutional Ethics Committee-YAMER.
