OsteoarthritisPhase 2NSAIDNCT05993247
Efficacy of Probiotics for NSAID-induced Enteropathy in Arthritis Patients
A Phase 2 study testing Probiotics capsule in people with Osteoarthritis, run by Jae Myung Park.
Trial summary
This study aimed to investigate the efficacy of probiotics as a preventive agent for NSAID-induced enteropathy. Arthritis patients are randomly divided into probiotic and placebo groups, and the drug is administered for eight weeks. Read more about this study
- Who is it for?
- Ages 19 to 75 years
- Conditions the study is for
- Osteoarthritis
- What is being tested?
- Probiotics capsule
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- No sites listed yet
- Study dates
- 20 Aug 2023to 31 Aug 2025
- Phase
- Phase 2
- 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 19 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with axial SpA who meet the 2009 ASAS criteria or osteoarthritis diagnosed by hand or foot x-rays
Who cannot join
- History of taking NSAIDs or antibiotics within the last month
- Those who have been taking probiotics, steroids, or immunosuppressants for a long time
- Abdominal surgical history (exception: appendectomy, cholecystectomy)
- History of gastrointestinal malignant disease
- Abnormal findings requiring drug treatment or surgery in upper gastrointestinal endoscopy (e.g., digestive cancer, acute peptic ulcer, etc.)
- Hemorrhagic disease
- Anemia with hemoglobin less than 10 g/dL
- Past NSAIDs drug side effects (allergy)
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Efficacy of Probiotics for Non-steroidal Anti-inflammatory Drug-induced Enteropathy in Arthritis Patients: A Double-blinded Pilot Randomized Controlled Trial
This study aimed to investigate the efficacy of probiotics as a preventive agent for NSAID-induced enteropathy. Arthritis patients are randomly divided into probiotic and placebo groups, and the drug is administered for eight weeks. Before and after drug administration, the patient's symptoms/degree of small bowel injuries on capsule endoscopy/microbiome composition and diversity were investigated.
Read the detailed description
Background:
Due to aging, there are many long-term users of NSAIDs, increasing enteropathy. The prophylactic effect of misoprostol, which is currently used, has not been proven, and misoprostol's long-term compliance and safety remain questionable. Rebamipide shows insignificant effects in both treatment and prophylaxis.
Probiotics have been reported to affect enteropathy in animal and human studies. However, there needs to be more verification studies, and there needs to be confirmatory studies on the importance of the microbiome in the small bowel. However, it is expected that there will be fewer complications and less patient resistance, resulting in higher drug compliance.
Purpose: To identify the efficacy of probiotics on NSAID-induced enteropathy in arthritis patients by capsule endoscopy and questionnaire, and to analysis the composition and diversity of the microbiome
Design: Double-blinded randomized controlled, pilot study
Participant: Patients diagnosed with osteoarthritis and starting NSAIDs
Methods: Randomly administering Probiotics or Placebo for eight weeks and comparing "before and after administration" in arthritis patients
- Survey of patient symptoms for enteropathy
- Recovery of small bowel mucosal injuries in capsule endoscopy
- Analysis of the composition and diversity of the microbiome
- Adverse events
Outcome
- Primary outcome: To assess whether probiotics can reduce small bowel injuries caused by NSAIDs
- Secondary outcome:
- To investigate whether probiotics can reduce gastrointestinal symptoms caused by NSAIDs
- To identify the improvement of arthritis symptoms
- To examine whether the distribution of the microbiome can be converted into beneficial bacteria by administering probiotics
- Conditions
- Osteoarthritis
- Being tested
- Probiotics capsule, Placebo capsule
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Probiotics capsuleCombination product
Subjects will take a probiotics combination capsule (Bacillus Subtilis 150 mg /Clostridium Burtyricum Toa 150 mg /Saccharomyces Boulardii 113 mg) three times a day for 8 weeks in combination with NSAIDs
Placebo capsuleCombination product
Subjects will take a placebo capsule identical in shape and size to probiotics capsule three times a day for 8 weeks in combination with NSAIDs
| Study group | Role | What they receive |
|---|---|---|
| Probiotics arm | Active comparator | Probiotics combination capsule (Bacillus Subtilis 150 mg /Clostridium Burtyricum Toa 150 mg /Saccharomyces Boulardii 113 mg) per oral, three times a day, for 8 weeks Receives: Combination Product: Probiotics capsule |
| Placebo arm | Placebo comparator | Placebo capsule in the same form as probiotics, per oral, three times a day, for 8 weeks Receives: Combination Product: Placebo capsule |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in the small bowel injuries on capsule endoscopy
Changes in the number of ulcers/erosions in the small bowel mucosa on capsule endoscopy before and after taking the NSAIDs and Probiotics/Placebo
Measured: From enrollment to the end of treatment at 8 weeks
Secondary outcomes (4)
Change from Baseline in Gastrointestinal Symptom Rating Scale (GSRS) Questionnaire Scores
Change from Baseline in Gastrointestinal Symptom Rating Scale Questionnaire Scores at 8 Weeks
- Symptoms: Pain or discomfort in upper abdomen, Heartburn, Acid reflux, Hunger pangs, Nausea, Rumbling, Bloating, Passing gas, Constipation, Diarrhea, Loose stool, Hard stool, Urgent bowel movement, Sensation of not completely emptying bowel
- Scoring: Each of the 15 items is scored from 0 to 6 points, with the highest score being 45 points and the lowest being 0 points. A score of 0 means no gastrointestinal symptoms, and a higher score indicates a more frequent occurrence of the corresponding symptoms.
Measured: From enrollment to the end of treatment at 8 weeks
Change From Baseline in Symptom Scores on the Western Ontario and McMaster Universities (WOMAC) Arthritis Index
- WOMAC index: Descending stairs, Ascending stairs, Rising from sitting, Standing, Bending to floor, Walking on flat surface, Getting in/out of car, Going shopping, Putting on socks, Lying in bed, Talking off socks, Rising from bed, Getting in/out of bath, Sitting, Getting on/off toilet, Heavy domestic duties, Light domestic duties
- Each of the 24 items is scored from 0 to 4 points, with the highest score being 96 points and the lowest being 0 points. A score of 0 means no symptoms and a higher score indicates more severe symptoms of the corresponding symptoms.
Measured: From enrollment to the end of treatment at 8 weeks
Change From Baseline in Symptom Scores on the Knee Injury and Osteoarthritis Outcome Scores (KOOS) Questionnaire at 8 Weeks
- Assessment of KOOS: Daily living, Sports and recreational activities, Pain, Quality of life, Symptoms and stiffness
- Each of the 42 items is scored from 0 to 4 points, with the highest score being 168 points and the lowest being 0 points. A score of 0 means no symptoms, and a higher score indicates more severe and frequent symptoms of the corresponding symptoms.
Measured: From enrollment to the end of treatment at 8 weeks
Changes in the gut microbiome through Next Generation Sequencing
- Changes in composition and diversity of gut microbiota through stool samples
- Changes in microbial genome composition
Measured: From enrollment to the end of treatment at 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2023
- Study start20 Aug 2023 (estimated)
- Primary completion31 Aug 2025 (estimated)
- Study completion31 Aug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteoarthritisStudies 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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Probiotics group vs. Placebo group
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jae Myung Park
- Sponsor type
- University, hospital or other
- Collaborators
- Daewoong Pharmaceutical Co. LTD.
- Responsible party
- Sponsor-investigator, Jae Myung Park, Seoul St. Mary's Hospital
- Investigators
- Jae Myung Park, MD, Study chair, The Catholic University of Korea
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05993247
- Sponsor's protocol ID
- KC23MISI0269
- Acronym
- NSAID
- Status last verified
- Aug 2023
- First submitted
- 20 Jul 2023
- Last updated
- 15 Aug 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Probiotics for Non-steroidal Anti-inflammatory Drug-induced Enteropathy in Arthritis Patients: A Double-blinded Pilot Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05993247
- Acronym / sponsor ID
- NSAID / KC23MISI0269
- Conditions
- Osteoarthritis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Jae Myung ParkUniversity, hospital or other
- Collaborators
- Daewoong Pharmaceutical Co. LTD.
- Study start
- 20 Aug 2023 (estimated)
- Primary completion
- 31 Aug 2025 (estimated)
- Study completion
- 31 Aug 2025 (estimated)
- First posted
- 15 Aug 2023 (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.
This study aimed to investigate the efficacy of probiotics as a preventive agent for NSAID-induced enteropathy. Arthritis patients are randomly divided into probiotic and placebo groups, and the drug is administered for eight weeks. Before and after drug administration, the patient's symptoms/degree of small bowel injuries on capsule endoscopy/microbiome composition and diversity were investigated.
Detailed description
Background:
Due to aging, there are many long-term users of NSAIDs, increasing enteropathy. The prophylactic effect of misoprostol, which is currently used, has not been proven, and misoprostol's long-term compliance and safety remain questionable. Rebamipide shows insignificant effects in both treatment and prophylaxis.
Probiotics have been reported to affect enteropathy in animal and human studies. However, there needs to be more verification studies, and there needs to be confirmatory studies on the importance of the microbiome in the small bowel. However, it is expected that there will be fewer complications and less patient resistance, resulting in higher drug compliance.
Purpose: To identify the efficacy of probiotics on NSAID-induced enteropathy in arthritis patients by capsule endoscopy and questionnaire, and to analysis the composition and diversity of the microbiome
Design: Double-blinded randomized controlled, pilot study
Participant: Patients diagnosed with osteoarthritis and starting NSAIDs
Methods: Randomly administering Probiotics or Placebo for eight weeks and comparing "before and after administration" in arthritis patients
- Survey of patient symptoms for enteropathy
- Recovery of small bowel mucosal injuries in capsule endoscopy
- Analysis of the composition and diversity of the microbiome
- Adverse events
Outcome
- Primary outcome: To assess whether probiotics can reduce small bowel injuries caused by NSAIDs
- Secondary outcome:
- To investigate whether probiotics can reduce gastrointestinal symptoms caused by NSAIDs
- To identify the improvement of arthritis symptoms
- To examine whether the distribution of the microbiome can be converted into beneficial bacteria by administering probiotics
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Probiotics group vs. Placebo group
| Arm | Type | Receives |
|---|---|---|
| Probiotics arm | Active comparator | Combination Product: Probiotics capsuleProbiotics combination capsule (Bacillus Subtilis 150 mg /Clostridium Burtyricum Toa 150 mg /Saccharomyces Boulardii 113 mg) per oral, three times a day, for 8 weeks |
| Placebo arm | Placebo comparator | Combination Product: Placebo capsulePlacebo capsule in the same form as probiotics, per oral, three times a day, for 8 weeks |
Who may qualify
- Ages
- 19 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with axial SpA who meet the 2009 ASAS criteria or osteoarthritis diagnosed by hand or foot x-rays
Key exclusion criteria (8 listed)
- History of taking NSAIDs or antibiotics within the last month
- Those who have been taking probiotics, steroids, or immunosuppressants for a long time
- Abdominal surgical history (exception: appendectomy, cholecystectomy)
- History of gastrointestinal malignant disease
- Abnormal findings requiring drug treatment or surgery in upper gastrointestinal endoscopy (e.g., digestive cancer, acute peptic ulcer, etc.)
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 |
|---|---|---|
| Probiotics capsuleSubjects will take a probiotics combination capsule (Bacillus Subtilis 150 mg /Clostridium Burtyricum Toa 150 mg /Saccharomyces Boulardii 113 mg) three times a day for 8 weeks in combination with NSAIDs | Combination product | Probiotics arm |
| Placebo capsuleSubjects will take a placebo capsule identical in shape and size to probiotics capsule three times a day for 8 weeks in combination with NSAIDs | Combination product | Placebo arm |
Primary outcome
Changes in the small bowel injuries on capsule endoscopy
Time frame: From enrollment to the end of treatment at 8 weeks
Changes in the number of ulcers/erosions in the small bowel mucosa on capsule endoscopy before and after taking the NSAIDs and Probiotics/Placebo
4 secondary outcomes
Change from Baseline in Gastrointestinal Symptom Rating Scale (GSRS) Questionnaire Scores
Time frame: From enrollment to the end of treatment at 8 weeks
Change From Baseline in Symptom Scores on the Western Ontario and McMaster Universities (WOMAC) Arthritis Index
Time frame: From enrollment to the end of treatment at 8 weeks
Change From Baseline in Symptom Scores on the Knee Injury and Osteoarthritis Outcome Scores (KOOS) Questionnaire at 8 Weeks
Time frame: From enrollment to the end of treatment at 8 weeks
Changes in the gut microbiome through Next Generation Sequencing
Time frame: From enrollment to the end of treatment at 8 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2023.
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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.
Jae Myung Park, MD study chair
The Catholic University of Korea
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Probiotics capsule in people with Osteoarthritis, run by Jae Myung Park.
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 8 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: status not confirmed, as of the sponsor's last update on 15 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jae Myung Park, MD (+82222586023, parkjerry@catholic.ac.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in the small bowel injuries on capsule endoscopy (time frame: From enrollment to the end of treatment at 8 weeks). 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 15 Aug 2023.