Probiotic Supplements in Osteoarthritis

NCT07364578 | Recruiting Phase 3

• 1 other identifier: Probiotic1
• Study Type: interventional
• Target: 146
• Locations: 1 country
• Sites: 1

Brief Summary

The current study aims to evaluate the effectiveness of adding probiotics to the standard of care in improving OA patient-related outcomes such as pain, stiffness, and physical activity.

Conditions

Osteoarthritis, Knee

Outcome Measures

Primary Outcomes (2)

• The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)

  A self-administered measure used in assessing pain, stiffness, and function in OA patients

  3 months

• Visual Analogue Scale (VAS)

  A pain rating scale that represents the severity of symptoms from 0 "no symptoms" to 10 "very severe symptoms." The patient marks the line according to his/her perception of their current state.

  3 months

Secondary Outcomes (1)

• The Knee Injury and Osteoarthritis Outcome Score (KOOS)

  3 months

Study Arms (2)

Control group

OTHER

OA patients will receive only standard of care

Drug: Control

probiotic group

EXPERIMENTAL

OA patients will receive probiotic supplements (2 times daily) added to the standard of care.

Drug: Probiotic Formula

Interventions

Probiotic Formula DRUG

probiotic supplements (lactobacillus, 2 times daily) added to standard of care

probiotic group

Control DRUG

standard of care

Control group

Eligibility Criteria

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

You may qualify if:

• Patients (both sexes) aged above 18 years who met the American College of Rheumatology (ACR) clinical criteria for KOA \[7\] and had symptomatic OA of at least one knee (index knee).

You may not qualify if:

• Rheumatoid arthritis or other active generalized inflammatory comorbidities affecting the gastrointestinal tract (IBD, celiac disease)
• Performed a total knee replacement on the affected knee or the waiting list for joint replacement
• surgeries (such as gastric bypass) or Other concomitant injuries can override OA symptoms or interfere with physical activity.
• Malabsorption disorders, systemic organ failure (liver, renal, cardiac)
• Use corticosteroids with doses above 10 mg/day or Intra-articular injections during the previous 6 months.
• Recent antibiotic treatment (i.e., \<2 months before the beginning of the study).
• Pregnancy/breastfeeding
• Participants who smoked more than 10 cigarettes per day were excluded.
• Immunosuppressive treatment or impaired immune system
• Chronic or acute diarrhea
• Blood/plasma donation/transfusion during the 3 months of the study
• Non-controlled diabetes
• Allergy with regards to any of the study product ingredients.
• Post-traumatic OA (e.g., fractures), congenital hip deformities, or degenerative or non-degenerative neurological conditions can alter pain perception.

Sponsors & Collaborators

• Beni-Suef University: lead

Study Sites (1)

Asmaa Abdelfattah Elsayed

Banī Suwayf, 82511, Egypt

RECRUITING

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Asmaa Elsayed

  Beni-Suef University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Asmaa A Elsayed

CONTACT

01095727201; asmaa.abdelfattah@pharm.sohag.edu.eg

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: outcome assessors were blinded to participant data. the researcher coded patient data before analysis
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of clinical pharmacy

Study Record Dates

• First Submitted: January 16, 2026
• First Posted: January 23, 2026
• Study Start: February 15, 2025
• Primary Completion: February 15, 2026
• Study Completion: March 1, 2026
• Last Updated: January 30, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)