Osteoarthritis, KneePhase 3NCT07364578
Probiotic Supplements in Osteoarthritis
A Phase 3 study testing Probiotic Formula in people with Osteoarthritis, Knee, run by Beni-Suef University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Osteoarthritis, Knee
- What is being tested?
- Probiotic Formula
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 146 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Feb 2025to 1 May 2026
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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).
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluating the Efficacy of Probiotic Supplements on Osteoarthritis Patients
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.
Read the detailed description
Osteoarthritis (OA) is a severe progressive chronic arthropathy causing articular remodeling and inflammation of synovial tissue. The disease involves the entire synovial joint, including the cartilage, joint lining, and subchondral bone. OA causes pain, swelling, and stiffness, consequently hindering the patient's ability to perform their main daily activities, which often leads to social isolation and depression. Up till now, there is no cure for OA treatment options target either symptomatic relief (mainly pain) such as acetaminophen, glucosamine, chondroitin sulfate, and non-steroidal anti-inflammatory drugs (NSAIDs) or structure repair.
Probiotics are live and active microorganisms widely known as the gut's beneficial bacteria. They are taken to alter the GI flora and provide health benefits such as achieving optimal digestion and immunological function.
- Conditions
- Osteoarthritis, Knee
- Being tested
- Probiotic Formula, Control
- 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 FormulaDrug
probiotic supplements (lactobacillus, 2 times daily) added to standard of care
ControlDrug
standard of care
| Study group | Role | What they receive |
|---|---|---|
| Control group | Other | OA patients will receive only standard of care Receives: Drug: Control |
| probiotic group | Experimental | OA patients will receive probiotic supplements (2 times daily) added to the standard of care. Receives: Drug: Probiotic Formula |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
A self-administered measure used in assessing pain, stiffness, and function in OA patients
Measured: 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.
Measured: 3 months
Secondary outcomes (1)
The Knee Injury and Osteoarthritis Outcome Score (KOOS)
a questionnaire designed to assess short and long-term patient-relevant outcomes following knee injury self-administered and assesses five outcomes: pain, symptoms, activities of daily living, sport and recreation function, and knee-related quality of life.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2026
- Study start15 Feb 2025
- Primary completion15 Feb 2026
- Study completion1 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoarthritis, KneeStudies of the same condition, open and under way.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 146 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beni-Suef University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Asmaa Abdelfattah Elsayed, Beni-Suef University
- Investigators
- Asmaa Elsayed, Principal investigator, Beni-Suef University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07364578
- Sponsor's protocol ID
- Probiotic1
- Status last verified
- Jul 2026
- First submitted
- 16 Jan 2026
- Last updated
- 24 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Efficacy of Probiotic Supplements on Osteoarthritis Patients
- ClinicalTrials.gov ID
- NCT07364578
- Acronym / sponsor ID
- Probiotic1
- Conditions
- Osteoarthritis, Knee
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 146 participants (actual)
- Lead sponsor
- Beni-Suef UniversityUniversity, hospital or other
- Study start
- 15 Feb 2025 (actual)
- Primary completion
- 15 Feb 2026 (actual)
- Study completion
- 1 May 2026 (actual)
- First posted
- 23 Jan 2026 (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.
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.
Detailed description
Osteoarthritis (OA) is a severe progressive chronic arthropathy causing articular remodeling and inflammation of synovial tissue. The disease involves the entire synovial joint, including the cartilage, joint lining, and subchondral bone. OA causes pain, swelling, and stiffness, consequently hindering the patient's ability to perform their main daily activities, which often leads to social isolation and depression. Up till now, there is no cure for OA treatment options target either symptomatic relief (mainly pain) such as acetaminophen, glucosamine, chondroitin sulfate, and non-steroidal anti-inflammatory drugs (NSAIDs) or structure repair.
Probiotics are live and active microorganisms widely known as the gut's beneficial bacteria. They are taken to alter the GI flora and provide health benefits such as achieving optimal digestion and immunological function.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | Other | Drug: ControlOA patients will receive only standard of care |
| probiotic group | Experimental | Drug: Probiotic FormulaOA patients will receive probiotic supplements (2 times daily) added to the standard of care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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).
Key exclusion criteria (14 listed)
- 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.
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 Formulaprobiotic supplements (lactobacillus, 2 times daily) added to standard of care | Drug | probiotic group |
| Controlstandard of care | Drug | Control group |
Primary outcome
The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
Time frame: 3 months
A self-administered measure used in assessing pain, stiffness, and function in OA patients
Visual Analogue Scale (VAS)
Time frame: 3 months
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.
1 secondary outcome
The Knee Injury and Osteoarthritis Outcome Score (KOOS)
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2026.
- Individual participant dataSharing planned: No
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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.
Asmaa Elsayed principal investigator
Beni-Suef University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Probiotic Formula in people with Osteoarthritis, Knee, run by Beni-Suef University at 1 site in Egypt.
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 1 inclusion and 14 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: finished, as of the sponsor's last update on 24 Jul 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 Egypt. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) (time frame: 3 months). The study lists 2 primary outcomes in all. 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 24 Jul 2026.