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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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

Other trials in Australia

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

Other trials in Bulgaria

New Zealand3 sites

  • Aotearoa Clinical Trials

    Auckland, 2025

  • Optimal Clinical Trials

    Auckland, 2025

  • Southern Clinical Trials

    Nelson, 7011

Other trials in New Zealand

Moldova2 sites

  • RTL SM SRL/ IMSP Institutul de Cardiologie

    Chisinau

  • Spitalul Clinic Republican Timofei Mosneaga

    Chisinau

Other trials in Moldova

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).

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 groups in NCT06005220
Study groupRoleWhat they receive
SBD121 Medical FoodActive comparatorTwo capsules administered twice daily with food
Receives: Other: SBD121
PlaceboPlacebo comparatorTwo 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.

  1. 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)

  1. Safety by Adverse Events

    Number and percentage of participants experiencing adverse events (AEs) and serious adverse events (SAEs)

    Measured: 16-weeks

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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

  9. 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

  10. 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

  11. 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

  12. C-Reactive Protein (CRP)

    Evaluate the dietary management of arthritis by the improvement in CRP from baseline

    Measured: 8-weeks, 16-weeks

  13. Eosinophil Sedimentation Rate (ESR)

    Evaluate the dietary management of arthritis by the improvement in ESR from baseline

    Measured: 8-weeks, 16-weeks

  14. Zonulin

    Evaluate improvement in gastrointestinal permeability by improvement in Zonulin from baseline

    Measured: 8-weeks, 16-weeks

  15. 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

  16. 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.

  1. First posted22 Aug 2023
  2. Study start30 Sep 2023
  3. Primary completion6 Oct 2025
  4. Study completion6 Oct 2025

Resources

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)
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

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?

On the ClinicalTrials.gov record for NCT06005220.

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.

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