Effect of Probiotic Supplements on Osteoarthritis Outcomes

NCT06459700 | Recruiting

• 1 other identifier: ProOA23
• Study Type: interventional
• Target: 86
• Locations: 1 country
• Sites: 1

Brief Summary

Dysbiosis of the gut microbiota is believed to contribute to the development and progression of osteoarthritis (OA), suggesting a role for probiotics in the treatment of OA. Animal studies have shown that certain probiotic strains decrease the inflammatory responses, pain sensitization and OA progression. There are, however, few clinical studies in humans to support this. In this double-blinded randomized controlled trial we will investigate the effect of 6-months probiotic supplements compared to placebo on OA related outcomes in females with diagnosed knee OA.

Conditions

Knee Osteoarthritis

Outcome Measures

Primary Outcomes (1)

• Knee injury and Osteoarthritis Outcome Score (KOOS)-12

  Change in the KOOS-12 (total score) from baseline to 6 months in the probiotic group compared with the placebo group. The KOOS-12 is scored from 1-100 (worst-best) scale.

  6 months

Secondary Outcomes (11)

• Knee injury and Osteoarthritis Outcome Score (separate subscale score)

  3 to 6 months

• Visual Analogue Scale (VAS)

  3 to 6 months

• Work Productivity and Activity Impairment questionnaire (WPAI)

  3 to 6 months

• Patient Acceptable Symptom State (PASS)

  3 to 6 months

• Pain-relieving medication intake

  3 to 6 months

Other Outcomes (3)

• Kinematics assessed with 3D motion analysis

  6 months

• Kinetics assessed with 3D motion analysis and force plates

  6 months

• Intestinal barrier integrity

  6 months

Study Arms (2)

Probiotic

ACTIVE COMPARATOR

One arm will receive probiotic supplement in opaque white capsules, 1 each day for six months

Dietary Supplement: Probiotic supplements

Placebo

PLACEBO COMPARATOR

One arm will receive identical opaque placebo capsules containing maize starch powder (placebo), 1 each day for six months

Dietary Supplement: Placebo supplements

Interventions

Probiotic supplements DIETARY_SUPPLEMENT

See arm/group description

Probiotic

Placebo supplements DIETARY_SUPPLEMENT

See arm/group description

Placebo

Eligibility Criteria

• Age: 45 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Females aged 45-70 years
• Clinical diagnosis of knee OA
• Mild to moderate knee joint pain (Visual Analog Scale (VAS) 3-7)) during the last 3 months
• Able to perform walking and stair tests
• No use of other supplements/food products containing probiotics and/or supplements targeting OA symptoms (e.g., glucosamine, turmeric)
• Able to write and understand Swedish.

You may not qualify if:

• Rheumatoid arthritis or other active generalised inflammatory comorbidities affecting the gastrointestinal tract (IBD, celiac disease)
• Performed a total knee replacement on the affected knee or on waiting list for joint replacement
• Other concomitant injuries or surgeries overriding the OA knee symptoms
• Other concomitant injuries or diseases where physical activity is a contra indication
• Malabsorption disorders, presence of renal and/or hepatic failure
• Use of corticosteroids with doses above 10 mg/day and/or Intra-articular injections during the previous 6 months
• Heavy use of alcohol (\>10 standard units a week), or recreational drug use
• BMI ≥30 Kg/m2
• Antibiotic treatment during the previous 2 months
• clinical depression diagnosis
• Pregnancy/breast feeding
• Smoking or other nicotine containing products during the previous 6months
• Performed a gastric bypass
• Immunosuppressive treatment or impaired immune system
• Chronic or acute diarrhoea

Sponsors & Collaborators

• Lund University: lead
• Probi AB: collaborator

Study Sites (1)

MoReLab, Lund University

Lund, 22100, Sweden

RECRUITING

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

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

Study Officials

• Eva Ageberg

  Lund University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Anna Cronström, PhD

CONTACT

+46462224965; anna.cronstrom@med.lu.se

Eva Ageberg, PhD

CONTACT

+46462224943; eva.ageberg@med.lu.se

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 22, 2024
• First Posted: June 14, 2024
• Study Start: July 1, 2024
• Primary Completion (Estimated): April 30, 2027
• Study Completion (Estimated): April 30, 2027
• Last Updated: July 5, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Statistical analysis plan will be published in a study protocol before completion of the analysis.

Locations

SE (1)