Rheumatoid ArthritisNCT06005220
SBD121, a Synbiotic Medical Food for RA Management
A study testing SBD121 in people with Rheumatoid Arthritis, run by Solarea Bio, Inc at 22 sites in 4 countries.
Trial summary
The aim of this randomised, double-blind, placebo controlled clinical food trial is to determine if the medical food SBD121 Synbiotic (prebiotic and probiotic) will aid in the dietary management of symptoms of early rheumatoid arthritis (RA). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Rheumatoid Arthritis
- What is being tested?
- SBD121
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 143 participants
- Where
- 22 sitesin 4 countries
- Study dates
- 30 Sep 2023to 6 Oct 2025
- Phase
- Interventional
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Willing and able to provide written informed consent prior to the performance of any study-specific procedure and willing to comply with the protocol and report on compliance and side effects during study period.
- Male or female aged 18 - 75 years inclusive at the time of consent.
- The participant must have newly diagnosed RA, not exceeding 1-year from diagnosis
- The participant must have been taking methotrexate (MTX) for treatment of RA for ≤ 75 days before baseline, or will be commencing MTX at the same time as baseline (within range 15 to 25 mg inclusive, recommended target dose of 20mg).
- The participant must have active RA meeting classification criteria according to the 2010 ACR/EULAR guidelines with a score equal to or greater than 6/10 at screening (11). (Seropositivity is not required).
- The participant must be available throughout entire study period, willing and able to attend all scheduled visits and in the opinion of the Investigator be able to understand and comply with planned study procedures.
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- Body Mass Index (BMI) between 18.5 and 40 kg/m2
- Normal cardiovascular parameters (systolic blood pressure ≤ 150 mm Hg, diastolic blood pressure ≤ 90 mm Hg). One re-test is permitted.
- Women of childbearing potential must have a negative serum pregnancy test at screening and negative urine pregnancy test pre-first administration, on Day 1, and must agree to remain sexually abstinent, or use medically effective contraception (refer to Appendix 11.1), or have a partner who is sterile or same-sex, from Screening until end of study. Males must not be planning to father children or donate sperm for the duration of the study.
Who cannot join
- Participant is currently taking any probiotic or prebiotic supplements, or has taken them in the past 7 days, or is unwilling to avoid taking probiotic/prebiotic supplements for the duration of the study.
- Participant has any known or suspected allergies to probiotics or prebiotics.
- Participant has taken oral or parenteral antibiotics within 21 days of screening, requires antibiotics pre-first dose, or is likely to require antibiotics during the study period.
- Participant has undergone major surgery within last 3-months before screening or planned during the study period
- Participant is a current or past smoker and/or user of nicotine replacement therapies (including vaping), that in the documented opinion of the Investigator, may adversely affect participation in the study, safety, and/or study outcomes.
- Participant has a past or current history of drug and/or alcohol abuse at the time of enrolment (the use of illegal drugs or the use of prescription or over-the-counter drugs or alcohol for purposes other than those for which they are meant to be used, or in excessive amounts).
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- Participant has a known history of any of the following (according to Investigator judgement and/or participant report):
- Gastric or intestinal dysmotility, slowed transit time, pancreatitis, or inflammatory bowel disease
- Known Hepatitis B or Hepatitis C infection, cirrhosis or chronic liver disease
- Underlying structural heart disease or previous history of endocarditis or valve replacement
- Rheumatic disease other than rheumatoid arthritis, including but not limited to psoriasis, spondyloarthritis, systemic lupus erythematosus, multiple sclerosis
- Immunosuppressed, including: known HIV positive; solid organ or stem cell transplant recipient; taking any oral or parenteral immunosuppressive therapy; neutrophil count <500/mm3; or anticipated drop in the neutrophil count to <500/mm3
- Any malignancy, with the exception of non-melanoma skin cancers, or other cancer more than 5-years ago
- Active tuberculosis (TB) within 3-months prior to Screening
- Any infection requiring hospitalisation, or as otherwise judged clinically significant, within 3-months prior to Screening
- Presence of any of the following active conditions at Screening, or within 72 hours of the first administration of study test article:
- Clinically significant abnormal vital signs or physical examination abnormalities (other than those related to RA, such as joint swelling)
- Febrile illness (temp. > 37.5 degrees Celsius), or one or more episodes of diarrhoea within 72 hours of the first dose of study test article
- Acute abdomen, colitis, or active GI disease
- Septicaemia or bacteraemia
- Uncontrolled diabetes mellitus, based on medical history and in response to query 'is your diabetes under control?'.
- Current treatment with any Disease Modifying Arthritis Drug (DMARD) other than methotrexate including but not limited to, hydroxychloroquine, sulfasalazine, and minocycline leflunomide, gold compounds, azathioprine, or cyclosporine will be exclusionary if used within 30 days prior to randomisation.
- Current or past treatment with any biologic agent including but not limited to tumor necrosis factor (TNF) inhibitors: etanercept, infliximab, adalimumab; interleukin 1 (IL-1) inhibitors: anakinra; lymphocyte directed: abatacept, rituximab; Janus kinase (JAK) inhibitors: tofacitinib; interleukin 17 (IL-17) inhibitors; Interleukin 23 (IL-23) inhibitors.
- Corticosteroid use from 30 days prior to randomisation until final assessment visit will be exclusionary, with the following exceptions:
- Oral corticosteroids in low doses (≤ 10 mg/d prednisone or equivalent) will be allowed if stable for 1-month prior to randomisation. Reduction of dose or use of oral corticosteroids is permissible throughout the study.
- Topical, inhaled, or intranasal steroids are permitted
- Past use of oral or parenteral (> 10 mg/d prednisone or equivalent) corticosteroids is allowed if not used within 1-month prior to randomisation.
- Women only - pregnant, planning on becoming pregnant during the trial, breastfeeding, positive urine pregnancy test during Screening or within 24 hours of first administration of study test article.
- Any of the following abnormal findings on Screening or Baseline laboratory tests (one re-test per timepoint permitted):
- White blood cells (WBCs) < lower limit of normal (LLN) or > upper limit of normal (ULN). If WBC is documented within normal range prior to commencing steroids and is deemed by the Investigator as elevated at screening due to recent addition of these drugs and not related to any other comorbidities, then may be suitable to proceed.
- Neutrophils < 1500/µl (1.5 x109/L)
- Platelets < 100 x 10³/µl (100 x 109/L)
- Haemoglobin < 9.0 g/dl (90 g/L)
- Serum Creatinine > 1.5 x ULN
- Glomerular filtration rate (GFR) of < or = 40 mL/minute
- Aspartate aminotransferase (AST) > 3 x ULN
- Alanine aminotransferase (ALT) > 3 x ULN
- Total Bilirubin > 1.5 x ULN
- Any other condition that in the opinion of the investigator would jeopardize the safety or rights of the volunteer participating in the study or would make it unlikely the volunteer could complete the study
- If the participant has been in a recent experimental trial, these must have been completed not less than 60 days prior to this study.
Trial locations and contacts
22 sites in 4 countries.
22 sites in 4 countries
Australia12 sites
Campbelltown Hospital
Campbelltown, New South Wales, 2560
Royal Prince Alfred Hospital
Camperdown, New South Wales, 2050
Paratus Clinical Canberra
Canberra, Australian Capital Territory, 2606
Liverpool Hospital
Liverpool, New South Wales, 2170
St. Vincents Hospital Melbourne
Melbourne, Victoria, 3065
Linear Clinical Trials
Nedlands, Western Australia, 6009
Genesis Research Services
Newcastle, New South Wales, 2292
BJC Health
Parramatta, New South Wales, 2150
Fiona Stanley Hospital
Perth, Western Australia, 6150
Western Health
St Albans, Victoria, 3021
Westmead Hospital
Westmead, New South Wales, 2145
Princess Alexandra Hospital
Woolloongabba, Queensland, 4102
Bulgaria5 sites
Diagnostic Consultative Center 1 - Lom EOOD
Lom, 3600
Medical Center - Teodora EOOD
Rousse, 7012
MHAT Lyulin EAD, Department of Rheumatology
Sofia, 1336
Diagnostic Consultative Center XIV - Sofia EOOD
Sofia, 1408
Medical Center Tera Medico EOOD
Vrasta, 3000
New Zealand3 sites
Aotearoa Clinical Trials
Auckland, 2025
Optimal Clinical Trials
Auckland, 2025
Southern Clinical Trials
Nelson, 7011
Moldova2 sites
RTL SM SRL/ IMSP Institutul de Cardiologie
Chisinau
Spitalul Clinic Republican Timofei Mosneaga
Chisinau
About this study
Official title: A Randomised, Double Blind Placebo-controlled Trial Evaluating the Medical Food Synbiotic SBD121, Versus Placebo for the Clinical Dietary Management of Early Rheumatoid Arthritis.
The aim of this randomised, double-blind, placebo controlled clinical food trial is to determine if the medical food SBD121 Synbiotic (prebiotic and probiotic) will aid in the dietary management of symptoms of early rheumatoid arthritis (RA).
- Conditions
- Rheumatoid Arthritis
- Being tested
- SBD121, Placebo
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SBD121Other
Medical Food
PlaceboOther
Placebo
| Study group | Role | What they receive |
|---|---|---|
| SBD121 Medical Food | Active comparator | Two capsules administered twice daily with food Receives: Other: SBD121 |
| Placebo | Placebo comparator | Two capsules administered twice daily with food Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
American College of Rheumatology 20 (ACR-20)
Evaluate the dietary management of arthritis by the number and percentage of participants achieving American College of Rheumatology 20 (ACR20) response (ie, greater to or equal to 20% improvement in the ACR composite score, a measure of RA symptoms including: joint swelling and tenderness; patient's assessment of pain, arthritis activity, and physical function; physician's assessment of arthritis activity; and CRP) at Week 16
Measured: 16 Weeks
Secondary outcomes (16)
Safety by Adverse Events
Number and percentage of participants experiencing adverse events (AEs) and serious adverse events (SAEs)
Measured: 16-weeks
Tolerability by GITQ
Frequency and severity of GI symptoms (e.g., gas, abdominal pain, bloating) as assessed by the Gastrointestinal Tolerability Questionnaire (GITQ) score at each timepoint compared to placebo.
Measured: 16-weeks
American College of Rheumatology 20 (ACR-20)
Evaluate the dietary management of arthritis by the number and percentage of participants achieving American College of Rheumatology 20 (ACR20) response (ie, greater to or equal to 20% improvement in the ACR composite score, a measure of RA symptoms including: joint swelling and tenderness; patient's assessment of pain, arthritis activity, and physical function; physician's assessment of arthritis activity; and CRP) at Week 8
Measured: 8 weeks
American College of Rheumatology 50 (ACR-50)
Evaluate the dietary management of arthritis by the number and percentage of participants achieving ACR50 response in the ACR composite score at Week 8, and Week 16
Measured: 8-weeks, 16-weeks
American College of Rheumatology 70 (ACR-70)
Evaluate the dietary management of arthritis by the number and percentage of participants achieving ACR70 response in the ACR composite score at Week 8, and Week 16
Measured: 8-weeks, 16-weeks
Disease Activity Score 28 - Eosinophil Sedimentation Rate (DAS28 - ESR)
Evaluate the dietary management of arthritis by the percentage change from baseline value in the Activity Score-28 (DAS-28) with ESR (DAS-28-ESR), and the individual components that make up the DAS-28-ESR [Tender Joint Count (TJC), Swollen Joint Count (SJC), and Patients Global Assessment of Activity, plus Erythrocyte Sedimentation Rate (ESR)], at 8 and 16 weeks
Measured: 8-weeks, 16-weeks
Disease Activity Score 28 - C-Reactive Protein (DAS28 - CRP)
Evaluate the dietary management of arthritis by the percentage change from baseline value in the DAS-28 with CRP score and the individual components that make up the DAS-28 CRP Score [Tender Joint Count (TJC), Swollen Joint Count (SJC), and Patients Global Assessment of Activity, plus C-Reactive Protein (CRP)], at 8 and 16 weeks
Measured: 8-weeks, 16-weeks
Disease Activity Score 28 - Eosinophil Sedimentation Rate - Low Disease Activity (DAS28 - ESR - LDA)
Evaluate the dietary management of arthritis by the percentage of participants who achieve DAS-28-ESR Low Activity defined as DAS-28-ESR Score < 3.2, at 8 and 16 weeks
Measured: 8-weeks, 16-weeks
Disease Activity Score 28 - C-Reactive Protein - Low Disease Activity (DAS28 - CRP LDA)
Evaluate the dietary management of arthritis by the percentage of participants who achieve DAS-28-CRP Low Activity, defined as DAS-28-CRP Score < 3.2, at 8 and 16 weeks
Measured: 8-weeks, 16-weeks
Disease Activity Score 28 - Eosinophil Sedimentation Rate - Remission (DAS28 - ESR Remission)
Evaluate the dietary management of arthritis by the percentage of participants who achieve DAS-28-ESR Remission defined as DAS-28-ESR Score < 2.6, at 8 and 16 weeks
Measured: 8-weeks, 16-weeks
Disease Activity Score 28 - C-Reactive Protein - Remission (DAS28 - CRP Remission)
Evaluate the dietary management of arthritis by the percentage of participants who achieve DAS-28-CRP Remission, defined as DAS-28-CRP Score < 2.6, at 8 and 16 weeks
Measured: 8-weeks, 16-weeks
C-Reactive Protein (CRP)
Evaluate the dietary management of arthritis by the improvement in CRP from baseline
Measured: 8-weeks, 16-weeks
Eosinophil Sedimentation Rate (ESR)
Evaluate the dietary management of arthritis by the improvement in ESR from baseline
Measured: 8-weeks, 16-weeks
Zonulin
Evaluate improvement in gastrointestinal permeability by improvement in Zonulin from baseline
Measured: 8-weeks, 16-weeks
Reduce or discontinue use of oral corticosteroids
Evaluate the dietary management of arthritis by the number and percentage of participants able to reduce dose or discontinue use of oral corticosteroids, at 8 and 16 weeks
Measured: 8-weeks, 16-weeks
Reduce or discontinue use of oral NSAIDs
Evaluate the dietary management of arthritis by the number and percentage of participants able to reduce dose or discontinue use of oral NSAIDs, at 8 and 16 weeks
Measured: 8-weeks, 16-weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2023
- Study start30 Sep 2023
- Primary completion6 Oct 2025
- Study completion6 Oct 2025
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 N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 143 participants (actual)
Sponsor and investigators
- Lead sponsor
- Solarea Bio, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Maureen Stanley, Study director, Southern Star Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06005220
- Sponsor's protocol ID
- SOL-SYNBIOTIC-2023
- Status last verified
- Aug 2025
- First submitted
- 7 Aug 2023
- Last updated
- 18 Dec 2025
- 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 18 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised, Double Blind Placebo-controlled Trial Evaluating the Medical Food Synbiotic SBD121, Versus Placebo for the Clinical Dietary Management of Early Rheumatoid Arthritis.
- ClinicalTrials.gov ID
- NCT06005220
- Acronym / sponsor ID
- SOL-SYNBIOTIC-2023
- Conditions
- Rheumatoid Arthritis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 143 participants (actual)
- Lead sponsor
- Solarea Bio, IncIndustry (pharma, biotech, devices)
- Study start
- 30 Sep 2023 (actual)
- Primary completion
- 6 Oct 2025 (actual)
- Study completion
- 6 Oct 2025 (actual)
- First posted
- 22 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.
The aim of this randomised, double-blind, placebo controlled clinical food trial is to determine if the medical food SBD121 Synbiotic (prebiotic and probiotic) will aid in the dietary management of symptoms of early rheumatoid arthritis (RA).
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SBD121 Medical Food | Active comparator | Other: SBD121Two capsules administered twice daily with food |
| Placebo | Placebo comparator | Other: PlaceboTwo capsules administered twice daily with food |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Willing and able to provide written informed consent prior to the performance of any study-specific procedure and willing to comply with the protocol and report on compliance and side effects during study period.
- Male or female aged 18 - 75 years inclusive at the time of consent.
- The participant must have newly diagnosed RA, not exceeding 1-year from diagnosis
- The participant must have been taking methotrexate (MTX) for treatment of RA for ≤ 75 days before baseline, or will be commencing MTX at the same time as baseline (within range 15 to 25 mg inclusive, recommended target dose of 20mg).
- The participant must have active RA meeting classification criteria according to the 2010 ACR/EULAR guidelines with a score equal to or greater than 6/10 at screening (11). (Seropositivity is not required).
Key exclusion criteria (40 listed)
- Participant is currently taking any probiotic or prebiotic supplements, or has taken them in the past 7 days, or is unwilling to avoid taking probiotic/prebiotic supplements for the duration of the study.
- Participant has any known or suspected allergies to probiotics or prebiotics.
- Participant has taken oral or parenteral antibiotics within 21 days of screening, requires antibiotics pre-first dose, or is likely to require antibiotics during the study period.
- Participant has undergone major surgery within last 3-months before screening or planned during the study period
- Participant is a current or past smoker and/or user of nicotine replacement therapies (including vaping), that in the documented opinion of the Investigator, may adversely affect participation in the study, safety, and/or study outcomes.
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 |
|---|---|---|
| SBD121Medical Food | Other | SBD121 Medical Food |
| PlaceboPlacebo | Other | Placebo |
Primary outcome
American College of Rheumatology 20 (ACR-20)
Time frame: 16 Weeks
Evaluate the dietary management of arthritis by the number and percentage of participants achieving American College of Rheumatology 20 (ACR20) response (ie, greater to or equal to 20% improvement in the ACR composite score, a measure of RA symptoms including: joint swelling and tenderness; patient's assessment of pain, arthritis activity, and physical function; physician's assessment of arthritis activity; and CRP) at Week 16
16 secondary outcomes
Safety by Adverse Events
Time frame: 16-weeks
Tolerability by GITQ
Time frame: 16-weeks
American College of Rheumatology 20 (ACR-20)
Time frame: 8 weeks
American College of Rheumatology 50 (ACR-50)
Time frame: 8-weeks, 16-weeks
American College of Rheumatology 70 (ACR-70)
Time frame: 8-weeks, 16-weeks
Disease Activity Score 28 - Eosinophil Sedimentation Rate (DAS28 - ESR)
Time frame: 8-weeks, 16-weeks
Disease Activity Score 28 - C-Reactive Protein (DAS28 - CRP)
Time frame: 8-weeks, 16-weeks
Disease Activity Score 28 - Eosinophil Sedimentation Rate - Low Disease Activity (DAS28 - ESR - LDA)
Time frame: 8-weeks, 16-weeks
Disease Activity Score 28 - C-Reactive Protein - Low Disease Activity (DAS28 - CRP LDA)
Time frame: 8-weeks, 16-weeks
Disease Activity Score 28 - Eosinophil Sedimentation Rate - Remission (DAS28 - ESR Remission)
Time frame: 8-weeks, 16-weeks
Disease Activity Score 28 - C-Reactive Protein - Remission (DAS28 - CRP Remission)
Time frame: 8-weeks, 16-weeks
C-Reactive Protein (CRP)
Time frame: 8-weeks, 16-weeks
Eosinophil Sedimentation Rate (ESR)
Time frame: 8-weeks, 16-weeks
Zonulin
Time frame: 8-weeks, 16-weeks
Reduce or discontinue use of oral corticosteroids
Time frame: 8-weeks, 16-weeks
Reduce or discontinue use of oral NSAIDs
Time frame: 8-weeks, 16-weeks
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 18 Dec 2025.
- 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.
Maureen Stanley study director
Southern Star Research
22 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SBD121 in people with Rheumatoid Arthritis, run by Solarea Bio, Inc at 22 sites in 4 countries.
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 9 inclusion and 40 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 18 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 22 sites in Australia, Bulgaria, New Zealand, Moldova. 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?
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?
American College of Rheumatology 20 (ACR-20) (time frame: 16 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 18 Dec 2025.