Effectiveness of Probiotics in Patients of Mild to Moderate Rheumatoid Arthritis

NCT06594822 | Completed Phase 3

• 1 other identifier: 8864/KEMU/2023
• Study Type: interventional
• Target: 88
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Rheumatoid Arthritis

Keywords

DAS-28; Probiotics; EULAR; NSAIDs; DMARDs; RF; anti-CCP; hsCRP; CBC; LFTs; RFTs; SPSS

Outcome Measures

Primary Outcomes (1)

• Disease Activity Score (DAS-28) score

  Reduction in DAS-28 score of ≥ 0.6 from the baseline. (Mild RA baseline score between 2.6 - 3.1, Moderate RA baseline score between 3.1 to \<5.1)

  3 months

Study Arms (2)

Group A, Probiotic Group

EXPERIMENTAL

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

Dietary Supplement: probiotic plus standard treatment

Group B, Standard treatment group

ACTIVE COMPARATOR

Standard therapy including NSAIDs, steroids and DMARDs

Drug: standard treatment

Interventions

probiotic plus standard treatment DIETARY_SUPPLEMENT

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

Group A, Probiotic Group

standard treatment DRUG

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

Also known as: NSAID, glucocorticoid and DMARD

Group B, Standard treatment group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• King Edward Medical University: lead

Study Sites (1)

Tazeen Nazar

Lahore, Punjab Province, 54000, Pakistan

Location

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

Probiotics; Anti-Inflammatory Agents, Non-Steroidal; Glucocorticoids; Antirheumatic Agents

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Dietary Supplements; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages; Analgesics, Non-Narcotic; Analgesics; Sensory System Agents; Peripheral Nervous System Agents; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Anti-Inflammatory Agents; Therapeutic Uses; Adrenal Cortex Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

• Gulraiz Iqbal, MBBS

  King Edward Medical University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Endocrinology

Model Details: Simple random selection of patients. Assigned to 2 groups by computer generated method. Group A received standard treatment of analgesics, glucocorticoids and methotrexate and or sulfasalazine. Group B was the interventional group that received probiotics in addition to standard treatment.

Study Record Dates

• First Submitted: August 18, 2024
• First Posted: September 19, 2024
• Study Start: August 24, 2023
• Primary Completion: January 23, 2024
• Study Completion: February 23, 2024
• Last Updated: September 19, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)