Rheumatoid ArthritisPhase 3NCT06594822
Effectiveness of Probiotics in Patients of Mild to Moderate Rheumatoid Arthritis
A Phase 3 study testing probiotic plus standard treatment and standard treatment in people with Rheumatoid Arthritis, run by King Edward Medical University at 1 site in Pakistan.
Trial summary
To assess the effectiveness of probiotics when given in combination with standard therapy in patients of mild to moderate rheumatoid arthritis Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Rheumatoid Arthritis
- What is being tested?
- probiotic plus standard treatment and standard treatment
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 88 participants
- Where
- 1 sitePakistan
- Study dates
- 24 Aug 2023to 23 Feb 2024
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Inclusion Criteria: 1- Patients of either sex. 2- Patients between the age group of 18 to 70 years. 3- Patients having an established diagnosis of rheumatoid arthritis (proven on history, X-rays and biologic markers like RF and Anti-CCP antibodies, ESR and CRP).
4- Patients having mild to moderate disease activity (DAS-28 score between 2.6 to <5.1).
Exclusion Criteria:1- Patients treated previously for RA with probiotics. 2- Patients with a history of allergy to probiotics. 3- Patients with mixed connective tissue disorder and overlap syndrome as per history and labs.
4- Patients with a history of gastrectomy, renal failure and liver cirrhosis. 5- Patients with recent or current use of antibiotics. 6- Pregnant patients and lactating mothers.
-
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of Probiotics and Standard Therapy Versus Standard Therapy Alone in Patients of Mild to Moderate Rheumatoid Arthritis
To assess the effectiveness of probiotics when given in combination with standard therapy in patients of mild to moderate rheumatoid arthritis
Read the detailed description
This study was conducted on the patients presenting to the Rheumatology out-patients department of the Department of Medicine, King Edward Medical University, Mayo hospital, Lahore from 24th August, 2023 till 23rd February, 2024. A total of 88 patients of either sex, between the age group of 18 to 70 years and having an established diagnosis of rheumatoid arthritis (RA), [as proved on history, X-rays and biologic markers like Rheumatoid Factor (RF) and Anti-cyclic citrullinated protein antibodies (anti-CCP antibodies), Erythrocyte Sedimentation Rate (ESR) and C- reactive protein (CRP)] and having mild to moderate disease activity score (DAS-28 score between 2.6 to <5.1) were selected via simple random sampling.
After approval from the Board of Studies (BOS) and Advanced Study Research Board (ASRB) of King Edward Medical University, Mayo Hospital, Lahore, all patients conforming to the selection criteria were enrolled in the study. Informed written and verbal consent was taken from all the participants. Patient's demographic data was obtained and recorded in a predesigned proforma. Patients were divided into two groups by computer generated method. Group A comprised 44 patients who received standard therapy [analgesics, glucocorticoids, any Disease modifying anti-rheumatic drug (DMARD)] alongwith probiotic (Bacillus clausii), whereas Group B also comprising 44 patients received standard therapy alone. Lab investigations like complete blood counts (CBC), C- reactive protein (CRP), liver function tests (LFTs) and renal function tests (RFTs) were done at baseline and then on follow up visits at 45 and 90 days. Disease activity score (DAS-28) was assessed on baseline then on each subsequent visit to monitor response to treatment. Mild RA patients had a DAS-28 score between 2.6 to 3.1 and moderate RA patients had a DAS-28 score between 3.1 to <5.1. Effectiveness was defined in terms of reduction of DAS-28 score of ≥0.6 from the baseline based on European League against Rheumatism (EULAR) response rates. Pancytopenia, derangement in LFTs and RFTs twice from the baseline as a result of treatment resulted in exclusion from the study.
Data was analyzed using computer software Statistical Package for Social Sciences (SPSS) version 26.0. Quantitative variables like age, DAS-28 score were expressed as mean and standard deviation (Mean±SD). Qualitative variables including gender were expressed as frequency and percentages. Chi- square test was used to compare response between the two groups. P value ≤0.05 was considered statistically significant.
- Conditions
- Rheumatoid Arthritis
- Being tested
- probiotic plus standard treatment, standard treatment
- Keywords
- DAS-28, Probiotics, EULAR, NSAIDs, DMARDs, RF, anti-CCP, hsCRP, CBC, LFTs, RFTs, SPSS
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
probiotic plus standard treatmentDietary supplement
Bacillus clausii, 5ml ampule containing 2 billion spores, given orally once daily
Also called NSAID, glucocorticoid and DMARD
diclofenac 50 mg twice a day, prednisone 5mg once daily, methotrexate 10mg once weekly or sulfasalazine 500 twice daily
| Study group | Role | What they receive |
|---|---|---|
| Group A, Probiotic Group | Experimental | Probiotics were given as an adjunct to standard therapy i.e., NSAIDs, Steroids, DMARDs Receives: Dietary Supplement: probiotic plus standard treatment |
| Group B, Standard treatment group | Active comparator | Standard therapy including NSAIDs, steroids and DMARDs Receives: Drug: standard treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease Activity Score (DAS-28) score
Reduction in DAS-28 score of ≥ 0.6 from the baseline. (Mild RA baseline score between 2.6 - 3.1, Moderate RA baseline score between 3.1 to <5.1)
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 posted19 Sep 2024
- Study start24 Aug 2023
- Primary completion23 Jan 2024
- Study completion23 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rheumatoid ArthritisStudies 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
- Model description
- Simple random selection of patients. Assigned to 2 groups by computer generated method. Group A received standard treatment of analgesics, glucocorticoids and methotrexate and or sulfasalazine. Group B was the interventional group that received probiotics in addition to standard treatment.
- Masking
- None (open label)
- Enrolment
- 88 participants (actual)
Sponsor and investigators
- Lead sponsor
- King Edward Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fawad Ahmad Randhawa, King Edward Medical University
- Investigators
- Gulraiz Iqbal, MBBS, Principal investigator, King Edward Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06594822
- Sponsor's protocol ID
- 8864/KEMU/2023
- Status last verified
- Sep 2024
- First submitted
- 18 Aug 2024
- Last updated
- 19 Sep 2024
- 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 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Probiotics and Standard Therapy Versus Standard Therapy Alone in Patients of Mild to Moderate Rheumatoid Arthritis
- ClinicalTrials.gov ID
- NCT06594822
- Acronym / sponsor ID
- 8864/KEMU/2023
- Conditions
- Rheumatoid Arthritis
- Keywords
- DAS-28, Probiotics, EULAR, NSAIDs, DMARDs, RF, anti-CCP, hsCRP
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 88 participants (actual)
- Lead sponsor
- King Edward Medical UniversityUniversity, hospital or other
- Study start
- 24 Aug 2023 (actual)
- Primary completion
- 23 Jan 2024 (actual)
- Study completion
- 23 Feb 2024 (actual)
- First posted
- 19 Sep 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.
To assess the effectiveness of probiotics when given in combination with standard therapy in patients of mild to moderate rheumatoid arthritis
Detailed description
This study was conducted on the patients presenting to the Rheumatology out-patients department of the Department of Medicine, King Edward Medical University, Mayo hospital, Lahore from 24th August, 2023 till 23rd February, 2024. A total of 88 patients of either sex, between the age group of 18 to 70 years and having an established diagnosis of rheumatoid arthritis (RA), [as proved on history, X-rays and biologic markers like Rheumatoid Factor (RF) and Anti-cyclic citrullinated protein antibodies (anti-CCP antibodies), Erythrocyte Sedimentation Rate (ESR) and C- reactive protein (CRP)] and having mild to moderate disease activity score (DAS-28 score between 2.6 to <5.1) were selected via simple random sampling.
After approval from the Board of Studies (BOS) and Advanced Study Research Board (ASRB) of King Edward Medical University, Mayo Hospital, Lahore, all patients conforming to the selection criteria were enrolled in the study. Informed written and verbal consent was taken from all the participants. Patient's demographic data was obtained and recorded in a predesigned proforma. Patients were divided into two groups by computer generated method. Group A comprised 44 patients who received standard therapy [analgesics, glucocorticoids, any Disease modifying anti-rheumatic drug (DMARD)] alongwith probiotic (Bacillus clausii), whereas Group B also comprising 44 patients received standard therapy alone. Lab investigations like complete blood counts (CBC), C- reactive protein (CRP), liver function tests (LFTs) and renal function tests (RFTs) were done at baseline and then on follow up visits at 45 and 90 days. Disease activity score (DAS-28) was assessed on baseline then on each subsequent visit to monitor response to treatment. Mild RA patients had a DAS-28 score between 2.6 to 3.1 and moderate RA patients had a DAS-28 score between 3.1 to <5.1. Effectiveness was defined in terms of reduction of DAS-28 score of ≥0.6 from the baseline based on European League against Rheumatism (EULAR) response rates. Pancytopenia, derangement in LFTs and RFTs twice from the baseline as a result of treatment resulted in exclusion from the study.
Data was analyzed using computer software Statistical Package for Social Sciences (SPSS) version 26.0. Quantitative variables like age, DAS-28 score were expressed as mean and standard deviation (Mean±SD). Qualitative variables including gender were expressed as frequency and percentages. Chi- square test was used to compare response between the two groups. P value ≤0.05 was considered statistically significant.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Simple random selection of patients. Assigned to 2 groups by computer generated method. Group A received standard treatment of analgesics, glucocorticoids and methotrexate and or sulfasalazine. Group B was the interventional group that received probiotics in addition to standard treatment.
| Arm | Type | Receives |
|---|---|---|
| Group A, Probiotic Group | Experimental | Dietary Supplement: probiotic plus standard treatmentProbiotics were given as an adjunct to standard therapy i.e., NSAIDs, Steroids, DMARDs |
| Group B, Standard treatment group | Active comparator | Drug: standard treatmentStandard therapy including NSAIDs, steroids and DMARDs |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 plus standard treatmentBacillus clausii, 5ml ampule containing 2 billion spores, given orally once daily | Dietary supplement | Group A, Probiotic Group |
| standard treatmentAlso: NSAID, glucocorticoid and DMARDdiclofenac 50 mg twice a day, prednisone 5mg once daily, methotrexate 10mg once weekly or sulfasalazine 500 twice daily | Drug | Group B, Standard treatment group |
Primary outcome
Disease Activity Score (DAS-28) score
Time frame: 3 months
Reduction in DAS-28 score of ≥ 0.6 from the baseline. (Mild RA baseline score between 2.6 - 3.1, Moderate RA baseline score between 3.1 to <5.1)
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 19 Sep 2024.
- Individual participant dataSharing planned: No
Related trials for Rheumatoid Arthritis
RecruitingPhase 2
Study of PTC844 in Participants With Active Rheumatoid Arthritis
Rheumatoid Arthritis
Not yet recruitingPhase 1
An Ascending Dose Study of DKB903 in Participants With Rheumatoid Arthritis (RA) and Participants With Systemic Lupus Erythematosus (SLE)
Rheumatoid Arthritis and Systemic Lupus Erythematosus
Recruiting
Effect of Anti-inflammatory Diet in Rheumatoid Arthritis
Rheumatoid Arthritis
Active, not recruitingPhase 2
A Study Evaluating the Safety and Efficacy of Inhaled AP01 in Participants With Progressive Pulmonary Fibrosis
Pulmonary Fibrosis, Progressive Pulmonary Fibrosis
RecruitingPhase 1
A Trial in Healthy Adult Participants and Adults With Autoimmune Diseases to Test How HBM7020 is Tolerated and How it Behaves in the Body
Rheumatoid Arthritis, Systemic Lupus Erythematosus
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.
Gulraiz Iqbal, MBBS principal investigator
King Edward Medical 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 plus standard treatment and standard treatment in people with Rheumatoid Arthritis, run by King Edward Medical University at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 19 Sep 2024. 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 Pakistan. 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?
Disease Activity Score (DAS-28) score (time frame: 3 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 19 Sep 2024; AzTrials last refreshed its copy on 8 Nov 2026.