Knee OsteoarthritisProOA23NCT06459700
Effect of Probiotic Supplements on Osteoarthritis Outcomes
A study testing Probiotic supplements in people with Knee Osteoarthritis, run by Lund University at 1 site in Sweden.
Trial 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. Read more about this study
- Who is it for?
- Ages 45 to 70 years, women only
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- Probiotic supplements
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 86 participants
- Where
- 1 siteSweden
- Study dates
- 1 Jul 2024to 30 Apr 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 18Show fewer
- 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
- Blood/plasma donation/transfusion during the 3months or during the study
- Non-controlled diabetes
- Allergy with regards to any of the study product ingredients.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of 6 Months Probiotic Supplement on Pain, Function, Quality of Life and Inflammation in Females With Knee Osteoarthritis: A Double-blinded Randomized Placebo-controlled Trial
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.
Read the detailed description
Aim:
To investigate the effect of 6-months 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-point difference in KOOS-12 with 80% power and α 0.05, 70 participants (35 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 and Jessica Neilands, PhD, Associate Professor, Science manager, Probi AB, Lund, Sweden.
- Conditions
- Knee Osteoarthritis
- Being tested
- Probiotic supplements, Placebo supplements
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Probiotic supplementsDietary supplement
See arm/group description
Placebo supplementsDietary supplement
See arm/group description
| Study group | Role | What they receive |
|---|---|---|
| Probiotic | Active comparator | One arm will receive probiotic supplement in opaque white capsules, 1 each day for six months Receives: 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 Receives: Dietary Supplement: Placebo supplements |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months
Secondary outcomes (11)
Knee injury and Osteoarthritis Outcome Score (separate subscale score)
Comparison of the probiotic group with the placebo group in terms of changes from baseline to 3-month and 6-month follow-up in Scores on the separate subscales (pain, symptoms, activity of daily living, sport/recreation and knee-related quality of life) from the full KOOS questionnaire. The KOOS is scored from 1-100 (worst-best) scale.
Measured: 3 to 6 months
Visual Analogue Scale (VAS)
Comparison of the probiotic group with the placebo group in terms of changes from baseline to 3-month and 6-month follow-up in VAS scores (pain severity), assessed on an ordinal scale from 0 to 10 where 0 indicates no pain and 10 worst possible pain the last week
Measured: 3 to 6 months
Work Productivity and Activity Impairment questionnaire (WPAI)
Comparison of the probiotic group with the placebo group in terms of changes from baseline to 3-month and 6-month follow-up in WPAI. The WPAI questionnaire includes 6 questions regarding employee's absenteeism, reduced job performance, work productivity loss, and activity impairment. WPAI outcomes are expressed as impairment percentages, with higher numbers indicating greater impairment and less productivity, i.e., worse outcomes.
Measured: 3 to 6 months
Patient Acceptable Symptom State (PASS)
Comparison of the probiotic group with the placebo group in terms of changes from baseline to 3-month and 6-month follow-up in PASS. The PASS involves a question regarding if the patient is satisfied with their current knee function with to response options (yes/no)
Measured: 3 to 6 months
Pain-relieving medication intake
Comparison of the probiotic group with the placebo group in terms of changes from baseline to 3-month and 6-month follow-up in pain-relieving medication intake. Here the patients reports the type and dosage of any medication
Measured: 3 to 6 months
Wish for surgery
Comparison of the probiotic group with the placebo group in terms of changes from baseline to 3-month and 6-month follow-up in wish for surgery. The patients are asked if they wish to undergo surgery due to their knee problems (yes/no).
Measured: 3 to 6 months
40m fast paced walk test
Comparison of the probiotic group with the placebo group in terms of changes from baseline and 6-month follow-up in 40m fast paced walk test, assessed as time taken to walk 4x10 meter as fast as possible
Measured: 6 months
30 seconds sit to stand test
Comparison of the probiotic group with the placebo group in terms of changes from baseline and 6-month follow-up in the 30 seconds sit to stand test, assessed by the number of repetitions of sitting to standing from a chair during a period of 30 second.
Measured: 6 months
Stair climb test
Comparison of the probiotic group with the placebo group in terms of changes from baseline and 6-month follow-up in the stair climb test, assessed as time taken to ascend and descend a flight of 5 stairs.
Measured: 6 months
3 minute walk test
Comparison of the probiotic group with the placebo group in terms of changes from baseline and 6-month follow-up in the 3 minute walk test, assessed as distance walked during 3 minutes on a treadmill.
Measured: 6 months
Molecular biomarkers for cartilage degeneration and inflammation.
Comparison of the probiotic group with the placebo group in terms of changes from baseline and 6-month follow-up in molecular biomarkers for cartilage degeneration and inflammation.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2024
- Study start1 Jul 2024
- Primary completion30 Apr 2027 (estimated)
- Study completion30 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee OsteoarthritisStudies of the same condition, open and under way.
- More trials run by Lund UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 86 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lund University
- Sponsor type
- University, hospital or other
- Collaborators
- Probi AB
- Responsible party
- Sponsor
- Investigators
- Eva Ageberg, Principal investigator, Lund University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06459700
- Sponsor's protocol ID
- ProOA23
- Acronym
- ProOA23
- Status last verified
- Mar 2026
- First submitted
- 22 May 2024
- Last updated
- 8 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Plan description: De-identified IPD for primary and secondary outcomes will be made available upon reasonable request.
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of 6 Months Probiotic Supplement on Pain, Function, Quality of Life and Inflammation in Females With Knee Osteoarthritis: A Double-blinded Randomized Placebo-controlled Trial
- ClinicalTrials.gov ID
- NCT06459700
- Acronym / sponsor ID
- ProOA23 / ProOA23
- Conditions
- Knee Osteoarthritis
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 86 participants (estimated)
- Lead sponsor
- Lund UniversityUniversity, hospital or other
- Collaborators
- Probi AB
- Study start
- 1 Jul 2024 (actual)
- Primary completion
- 30 Apr 2027 (estimated)
- Study completion
- 30 Apr 2027 (estimated)
- First posted
- 14 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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-months 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-point difference in KOOS-12 with 80% power and α 0.05, 70 participants (35 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 and Jessica Neilands, PhD, Associate Professor, Science manager, Probi AB, Lund, Sweden.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Probiotic | Active comparator | Dietary Supplement: Probiotic supplementsOne arm will receive probiotic supplement in opaque white capsules, 1 each day for six months |
| Placebo | Placebo comparator | Dietary Supplement: Placebo supplementsOne arm will receive identical opaque placebo capsules containing maize starch powder (placebo), 1 each day for six months |
Who may qualify
- Ages
- 45 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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)
Key exclusion criteria (18 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Probiotic supplementsSee arm/group description | Dietary supplement | Probiotic |
| Placebo supplementsSee arm/group description | Dietary supplement | Placebo |
Primary outcome
Knee injury and Osteoarthritis Outcome Score (KOOS)-12
Time frame: 6 months
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.
11 secondary outcomes
Knee injury and Osteoarthritis Outcome Score (separate subscale score)
Time frame: 3 to 6 months
Visual Analogue Scale (VAS)
Time frame: 3 to 6 months
Work Productivity and Activity Impairment questionnaire (WPAI)
Time frame: 3 to 6 months
Patient Acceptable Symptom State (PASS)
Time frame: 3 to 6 months
Pain-relieving medication intake
Time frame: 3 to 6 months
Wish for surgery
Time frame: 3 to 6 months
40m fast paced walk test
Time frame: 6 months
30 seconds sit to stand test
Time frame: 6 months
Stair climb test
Time frame: 6 months
3 minute walk test
Time frame: 6 months
Molecular biomarkers for cartilage degeneration and inflammation.
Time frame: 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2026.
- Individual participant dataSharing planned: Yes. Plan description: De-identified IPD for primary and secondary outcomes will be made available upon reasonable request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eva Ageberg principal investigator
Lund University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Probiotic supplements in people with Knee Osteoarthritis, run by Lund University at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 8 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Knee injury and Osteoarthritis Outcome Score (KOOS)-12 (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2026.