Effect of Probiotic Supplements on Osteoarthritis Outcomes

NCT ID: NCT06459700

Last Updated: 2024-07-05

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 86 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-07-01
• Study Completion Date: 2027-04-30

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.

Detailed Description

Aim:

To investigate the effect of 6-moths probiotic supplements compared to placebo on OA related outcomes in females with diagnosed knee OA.

Design: Double-blinded randomized placebo controlled trial

Study arms: One treatment arm will receive probiotic supplement in opaque white capsules and the other treatment arm will receive identical opaque placebo capsules. The placebo product will contain maize starch powder. Study participants will take one capsule daily for six months.

Statistical analysis Main outcome: The independent T-test will be used to evaluate group differences in change in KOOS-12 scores between baseline and 6-months follow-up, given that all assumptions for parametric tests are satisfied. If assumptions are not met or if there are differences in baseline characteristics due to imbalanced randomization the Mann-Whitney U-test or regression analysis will be used as appropriate.

Secondary and explorative outcomes: The independent T-test (continuous, normal distributed data), the Mann-Whitney U-test (ordinal, non-normally distributed data) and cross-tabulations with Chi2 test (nominal data) will be used to evaluate differences in secondary and explorative outcomes between the two groups.

Estimated enrollment: 86 participants. Based on the ability to detect a 10-score difference in KOOS-12 with 80% power and α 0.05, 72 participants (36 per arm) will be needed. With an approximate drop-out rate of 20% from baseline to follow-up, 86 participants will be recruited.

Investigators: Eva Ageberg, PT, PhD, Professor in physical therapy, Lund University, Sweden (Principal investigator), Anna Cronström, physical therapist, PhD, Lund University, Sweden, Jessica Neilands, PhD, Associate Professor, Science manager, Probi AB, Lund, Sweden and Daniel Benoit, PhD, senior lecturer in Experimental Health Sciences at Lund University, Sweden.

Conditions

Knee Osteoarthritis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: TRIPLE

Study Groups

Probiotic

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

Group Type: ACTIVE_COMPARATOR

Probiotic supplements

Intervention Type: DIETARY_SUPPLEMENT

See arm/group description

Placebo

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

Group Type: PLACEBO_COMPARATOR

Placebo supplements

Intervention Type: DIETARY_SUPPLEMENT

See arm/group description

Interventions

Probiotic supplements

See arm/group description

Intervention Type: DIETARY_SUPPLEMENT

Placebo supplements

See arm/group description

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

Inclusion Criteria

1. Females aged 45-70 years

2. Clinical diagnosis of knee OA

3. Mild to moderate knee joint pain (Visual Analog Scale (VAS) 3-7)) during the last 3 months

4. Able to perform walking and stair tests

5. No use of other supplements/food products containing probiotics and/or supplements targeting OA symptoms (e.g., glucosamine, turmeric)

6. Able to write and understand Swedish.

Exclusion Criteria

1. Rheumatoid arthritis or other active generalised inflammatory comorbidities affecting the gastrointestinal tract (IBD, celiac disease)

2. Performed a total knee replacement on the affected knee or on waiting list for joint replacement

3. Other concomitant injuries or surgeries overriding the OA knee symptoms

4. Other concomitant injuries or diseases where physical activity is a contra indication

5. Malabsorption disorders, presence of renal and/or hepatic failure

6. Use of corticosteroids with doses above 10 mg/day and/or Intra-articular injections during the previous 6 months

7. Heavy use of alcohol (>10 standard units a week), or recreational drug use

8. BMI ≥30 Kg/m2

9. Antibiotic treatment during the previous 2 months

10. clinical depression diagnosis

11. Pregnancy/breast feeding

12. Smoking or other nicotine containing products during the previous 6months

13. Performed a gastric bypass

14. Immunosuppressive treatment or impaired immune system

15. Chronic or acute diarrhoea

16. Blood/plasma donation/transfusion during the 3months or during the study

17. Non-controlled diabetes

18. Allergy with regards to any of the study product ingredients.

• Minimum Eligible Age: 45 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Probi AB

INDUSTRY

Sponsor Role: collaborator

Lund University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Eva Ageberg

Role: PRINCIPAL_INVESTIGATOR

Lund University

Locations

MoReLab, Lund University

Lund, , Sweden

Site Status: RECRUITING

Countries

Sweden

Central Contacts

Anna Cronström, PhD

Role: CONTACT

anna.cronstrom@med.lu.se

+46462224965

Eva Ageberg, PhD

Role: CONTACT

eva.ageberg@med.lu.se

+46462224943

Facility Contacts

Anna Cronström, PhD

Role: primary

anna.cronstrom@med.lu.se

+46462224965

Eva Ageberg, PhD

Role: backup

eva.ageberg@med.lu.se

+46462224943

Other Identifiers

ProOA23

Identifier Type: -

Identifier Source: org_study_id