Plain English Summary
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
Trial website
Contact information
Type
Public
Primary contact
Dr Arindam Roy
ORCID ID
http://orcid.org/0000-0003-2393-9689
Contact details
Yashoda Hospitals
Secunderabad
Hyderabad
500003
India
+91 9849279830
doctor.arindam@yahoo.com
Additional identifiers
EudraCT number
Nil known
ClinicalTrials.gov number
Nil known
Protocol/serial number
Nil known
Study information
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.
Acronym
Study hypothesis
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
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
Study design
Single centre interventional randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
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
Phase
Drug names
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 trial start date
23/08/2017
Overall trial end date
21/07/2019
Reason abandoned (if study stopped)
Eligibility
Participant 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)
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
250
Total final enrolment
250
Participant 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
Recruitment start date
05/03/2018
Recruitment end date
21/04/2019
Locations
Countries of recruitment
India
Trial participating centre
Yashoda Hospitals
Department of Rheumatology
Behind Hari Hara Kala Bhavan
Alexander Road
Secunderabad
500003
India
Sponsor information
Organisation
Yashoda Hospitals
Sponsor details
Behind Hari Hara Kala Bhavan
Alexander Road
Secunderabad
Hyderabad
500003
India
+91 9849279830
secunderabad@yashoda.in
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Other
Funder name
Investigator initiated and funded
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Planned publication in a high-impact peer-reviewed journal.
IPD sharing statement:
All data generated or analysed during this study will be included in the subsequent results publication
Intention to publish date
01/12/2020
Participant level data
Other
Basic results (scientific)
Publication list
Publication citations
Additional files
- ISRCTN79856269_PROTOCOL_V0_01Oct2020.pdf Uploaded 08/10/2020