Condition category
Musculoskeletal Diseases
Date applied
29/09/2020
Date assigned
02/10/2020
Last edited
08/10/2020
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting
Publication status
Results overdue

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

Editorial Notes

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.