Effectiveness of Probiotics in Patients of Mild to Moderate Rheumatoid Arthritis

NCT ID: NCT06594822

Last Updated: 2024-09-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 88 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-08-24
• Study Completion Date: 2024-02-23

Brief Summary

To assess the effectiveness of probiotics when given in combination with standard therapy in patients of mild to moderate rheumatoid arthritis

Detailed Description

This study was conducted on the patients presenting to the Rheumatology out-patients department of the Department of Medicine, King Edward Medical University, Mayo hospital, Lahore from 24th August, 2023 till 23rd February, 2024. A total of 88 patients of either sex, between the age group of 18 to 70 years and having an established diagnosis of rheumatoid arthritis (RA), [as proved on history, X-rays and biologic markers like Rheumatoid Factor (RF) and Anti-cyclic citrullinated protein antibodies (anti-CCP antibodies), Erythrocyte Sedimentation Rate (ESR) and C- reactive protein (CRP)] and having mild to moderate disease activity score (DAS-28 score between 2.6 to <5.1) were selected via simple random sampling.

After approval from the Board of Studies (BOS) and Advanced Study Research Board (ASRB) of King Edward Medical University, Mayo Hospital, Lahore, all patients conforming to the selection criteria were enrolled in the study. Informed written and verbal consent was taken from all the participants. Patient's demographic data was obtained and recorded in a predesigned proforma. Patients were divided into two groups by computer generated method. Group A comprised 44 patients who received standard therapy [analgesics, glucocorticoids, any Disease modifying anti-rheumatic drug (DMARD)] alongwith probiotic (Bacillus clausii), whereas Group B also comprising 44 patients received standard therapy alone. Lab investigations like complete blood counts (CBC), C- reactive protein (CRP), liver function tests (LFTs) and renal function tests (RFTs) were done at baseline and then on follow up visits at 45 and 90 days. Disease activity score (DAS-28) was assessed on baseline then on each subsequent visit to monitor response to treatment. Mild RA patients had a DAS-28 score between 2.6 to 3.1 and moderate RA patients had a DAS-28 score between 3.1 to <5.1. Effectiveness was defined in terms of reduction of DAS-28 score of ≥0.6 from the baseline based on European League against Rheumatism (EULAR) response rates. Pancytopenia, derangement in LFTs and RFTs twice from the baseline as a result of treatment resulted in exclusion from the study.

Data was analyzed using computer software Statistical Package for Social Sciences (SPSS) version 26.0. Quantitative variables like age, DAS-28 score were expressed as mean and standard deviation (Mean±SD). Qualitative variables including gender were expressed as frequency and percentages. Chi- square test was used to compare response between the two groups. P value ≤0.05 was considered statistically significant.

Conditions

Rheumatoid Arthritis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Group A, Probiotic Group

Probiotics were given as an adjunct to standard therapy i.e., NSAIDs, Steroids, DMARDs

Group Type: EXPERIMENTAL

probiotic plus standard treatment

Intervention Type: DIETARY_SUPPLEMENT

Bacillus clausii, 5ml ampule containing 2 billion spores, given orally once daily

Group B, Standard treatment group

Standard therapy including NSAIDs, steroids and DMARDs

Group Type: ACTIVE_COMPARATOR

standard treatment

Intervention Type: DRUG

diclofenac 50 mg twice a day, prednisone 5mg once daily, methotrexate 10mg once weekly or sulfasalazine 500 twice daily

Interventions

probiotic plus standard treatment

Bacillus clausii, 5ml ampule containing 2 billion spores, given orally once daily

Intervention Type: DIETARY_SUPPLEMENT

standard treatment

diclofenac 50 mg twice a day, prednisone 5mg once daily, methotrexate 10mg once weekly or sulfasalazine 500 twice daily

Intervention Type: DRUG

Other Intervention Names

NSAID, glucocorticoid and DMARD

Eligibility Criteria

Inclusion Criteria

4- Patients having mild to moderate disease activity (DAS-28 score between 2.6 to <5.1).

Exclusion Criteria

4- Patients with a history of gastrectomy, renal failure and liver cirrhosis. 5- Patients with recent or current use of antibiotics. 6- Pregnant patients and lactating mothers.

-

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

King Edward Medical University

OTHER

Sponsor Role: lead

Responsible Party

Fawad Ahmad Randhawa

Associate Professor of Endocrinology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Gulraiz Iqbal, MBBS

Role: PRINCIPAL_INVESTIGATOR

King Edward Medical University

Locations

Tazeen Nazar

Lahore, Punjab Province, Pakistan

Countries

Pakistan

Other Identifiers

8864/KEMU/2023

Identifier Type: -

Identifier Source: org_study_id