SBD121, a Synbiotic Medical Food for RA Management

NCT06005220 | Completed

• 1 other identifier: SOL-SYNBIOTIC-2023
• Study Type: interventional
• Target: 143
• Locations: 4 countries
• Sites: 22

Brief 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).

Conditions

Rheumatoid Arthritis

Outcome Measures

Primary Outcomes (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

  16 Weeks

Secondary Outcomes (16)

• Safety by Adverse Events

  16-weeks

• Tolerability by GITQ

  16-weeks

• American College of Rheumatology 20 (ACR-20)

  8 weeks

• American College of Rheumatology 50 (ACR-50)

  8-weeks, 16-weeks

• American College of Rheumatology 70 (ACR-70)

  8-weeks, 16-weeks

Other Outcomes (2)

• Microbiome functional composition by shotgun metagenomics

  16-weeks

• Microbiome taxonomic composition by shotgun metagenomics

  16-weeks

Study Arms (2)

SBD121 Medical Food

ACTIVE COMPARATOR

Two capsules administered twice daily with food

Other: SBD121

Placebo

PLACEBO COMPARATOR

Two capsules administered twice daily with food

Other: Placebo

Interventions

SBD121 OTHER

Medical Food

SBD121 Medical Food

Placebo OTHER

Placebo

Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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).
• 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

Sponsors & Collaborators

• Solarea Bio, Inc: lead

Study Sites (22)

Paratus Clinical Canberra

Canberra, Australian Capital Territory, 2606, Australia

Location

Campbelltown Hospital

Campbelltown, New South Wales, 2560, Australia

Location

Royal Prince Alfred Hospital

Camperdown, New South Wales, 2050, Australia

Location

Liverpool Hospital

Liverpool, New South Wales, 2170, Australia

Location

Genesis Research Services

Newcastle, New South Wales, 2292, Australia

Location

BJC Health

Parramatta, New South Wales, 2150, Australia

Location

Westmead Hospital

Westmead, New South Wales, 2145, Australia

Location

Princess Alexandra Hospital

Woolloongabba, Queensland, 4102, Australia

Location

St. Vincents Hospital Melbourne

Melbourne, Victoria, 3065, Australia

Location

Western Health

St Albans, Victoria, 3021, Australia

Location

Linear Clinical Trials

Nedlands, Western Australia, 6009, Australia

Location

Fiona Stanley Hospital

Perth, Western Australia, 6150, Australia

Location

Diagnostic Consultative Center 1 - Lom EOOD

Lom, 3600, Bulgaria

Location

Medical Center - Teodora EOOD

Rousse, 7012, Bulgaria

Location

MHAT Lyulin EAD, Department of Rheumatology

Sofia, 1336, Bulgaria

Location

Diagnostic Consultative Center XIV - Sofia EOOD

Sofia, 1408, Bulgaria

Location

Medical Center Tera Medico EOOD

Vrasta, 3000, Bulgaria

Location

RTL SM SRL/ IMSP Institutul de Cardiologie

Chisinau, Moldova

Location

Spitalul Clinic Republican Timofei Mosneaga

Chisinau, Moldova

Location

Aotearoa Clinical Trials

Auckland, 2025, New Zealand

Location

Optimal Clinical Trials

Auckland, 2025, New Zealand

Location

Southern Clinical Trials

Nelson, 7011, New Zealand

Location

MeSH Terms

Conditions

Arthritis, Rheumatoid

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Maureen Stanley

  Southern Star Research

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 7, 2023
• First Posted: August 22, 2023
• Study Start: September 30, 2023
• Primary Completion: October 6, 2025
• Study Completion: October 6, 2025
• Last Updated: December 18, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

BU (5); NZ (3); MO (2); AU (12)