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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT06005220




Registration number
NCT06005220
Ethics application status
Date submitted
7/08/2023
Date registered
22/08/2023
Date last updated
27/03/2024

Titles & IDs
Public title
SBD121, a Synbiotic Medical Food for RA Management
Scientific 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.
Secondary ID [1] 0 0
SOL-SYNBIOTIC-2023
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Rheumatoid Arthritis 0 0
Condition category
Condition code
Musculoskeletal 0 0 0 0
Osteoarthritis
Inflammatory and Immune System 0 0 0 0
Rheumatoid arthritis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other interventions - SBD121
Other interventions - Placebo

Active Comparator: SBD121 Medical Food - Two capsules administered twice daily with food

Placebo Comparator: Placebo - Two capsules administered twice daily with food


Other interventions: SBD121
Medical Food

Other interventions: Placebo
Placebo
Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
American College of Rheumatology 20 (ACR-20)
Timepoint [1] 0 0
16 Weeks
Secondary outcome [1] 0 0
Safety by Adverse Events
Timepoint [1] 0 0
16-weeks
Secondary outcome [2] 0 0
Tolerability by GITQ
Timepoint [2] 0 0
16-weeks
Secondary outcome [3] 0 0
American College of Rheumatology 20 (ACR-20)
Timepoint [3] 0 0
8 weeks
Secondary outcome [4] 0 0
American College of Rheumatology 50 (ACR-50)
Timepoint [4] 0 0
8-weeks, 16-weeks
Secondary outcome [5] 0 0
American College of Rheumatology 70 (ACR-70)
Timepoint [5] 0 0
8-weeks, 16-weeks
Secondary outcome [6] 0 0
Disease Activity Score 28 - Eosinophil Sedimentation Rate (DAS28 - ESR)
Timepoint [6] 0 0
8-weeks, 16-weeks
Secondary outcome [7] 0 0
Disease Activity Score 28 - C-Reactive Protein (DAS28 - CRP)
Timepoint [7] 0 0
8-weeks, 16-weeks
Secondary outcome [8] 0 0
Disease Activity Score 28 - Eosinophil Sedimentation Rate - Low Disease Activity (DAS28 - ESR - LDA)
Timepoint [8] 0 0
8-weeks, 16-weeks
Secondary outcome [9] 0 0
Disease Activity Score 28 - C-Reactive Protein - Low Disease Activity (DAS28 - CRP LDA)
Timepoint [9] 0 0
8-weeks, 16-weeks
Secondary outcome [10] 0 0
Disease Activity Score 28 - Eosinophil Sedimentation Rate - Remission (DAS28 - ESR Remission)
Timepoint [10] 0 0
8-weeks, 16-weeks
Secondary outcome [11] 0 0
Disease Activity Score 28 - C-Reactive Protein - Remission (DAS28 - CRP Remission)
Timepoint [11] 0 0
8-weeks, 16-weeks
Secondary outcome [12] 0 0
C-Reactive Protein (CRP)
Timepoint [12] 0 0
8-weeks, 16-weeks
Secondary outcome [13] 0 0
Eosinophil Sedimentation Rate (ESR)
Timepoint [13] 0 0
8-weeks, 16-weeks
Secondary outcome [14] 0 0
Zonulin
Timepoint [14] 0 0
8-weeks, 16-weeks
Secondary outcome [15] 0 0
Reduce or discontinue use of oral corticosteroids
Timepoint [15] 0 0
8-weeks, 16-weeks
Secondary outcome [16] 0 0
Reduce or discontinue use of oral NSAIDs
Timepoint [16] 0 0
8-weeks, 16-weeks

Eligibility
Key inclusion criteria
1. 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.

2. Male or female aged 18 - 75 years inclusive at the time of consent.

3. The participant must have newly diagnosed RA, not exceeding 1-year from diagnosis

4. 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).

5. 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).

6. 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.

7. Body Mass Index (BMI) between 18.5 and 40 kg/m2

8. Normal cardiovascular parameters (systolic blood pressure = 150 mm Hg, diastolic blood
pressure = 90 mm Hg). One re-test is permitted.

9. 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.
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. 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.

2. Participant has any known or suspected allergies to probiotics or prebiotics.

3. 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.

4. Participant has undergone major surgery within last 3-months before screening or
planned during the study period

5. Participant is a current smoker and/or uses nicotine replacement therapies (including
vaping).

6. 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).

7. Participant has a known history of any of the following (according to Investigator
judgement and/or participant report):

1. Gastric or intestinal dysmotility, slowed transit time, pancreatitis, or
inflammatory bowel disease

2. Known Hepatitis B or Hepatitis C infection, cirrhosis or chronic liver disease

3. Underlying structural heart disease or previous history of endocarditis or valve
replacement

4. Rheumatic disease other than rheumatoid arthritis, including but not limited to
psoriasis, spondyloarthritis, systemic lupus erythematosus, multiple sclerosis

5. 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

6. Any malignancy, with the exception of non-melanoma skin cancers, or other cancer
more than 5-years ago

7. Active tuberculosis (TB) within 3-months prior to Screening

8. Any infection requiring hospitalisation, or as otherwise judged clinically
significant, within 3-months prior to Screening

8. Presence of any of the following active conditions at Screening, or within 72 hours of
the first administration of study test article:

1. Clinically significant abnormal vital signs or physical examination abnormalities
(other than those related to RA, such as joint swelling)

2. 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

3. Acute abdomen, colitis, or active GI disease

4. Septicaemia or bacteraemia

5. Uncontrolled diabetes mellitus, based on medical history and in response to query
'is your diabetes under control?'.

9. 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.

10. 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.

11. Corticosteroid use from 30 days prior to randomisation until final assessment visit
will be exclusionary, with the following exceptions:

1. 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.

2. Topical, inhaled, or intranasal steroids are permitted

3. Past use of oral or parenteral (> 10 mg/d prednisone or equivalent)
corticosteroids is allowed if not used within 1-month prior to randomisation.

12. 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.

13. Any of the following abnormal findings on Screening or Baseline laboratory tests (one
re-test per timepoint permitted):

1. 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.

2. Neutrophils < 1500/µl (1.5 x109/L)

3. Platelets < 100 x 10³/µl (100 x 109/L)

4. Haemoglobin < 9.0 g/dl (90 g/L)

5. Serum Creatinine > 1.5 x ULN

6. Glomerular filtration rate (GFR) of < or = 40 mL/minute

7. Aspartate aminotransferase (AST) > 3 x ULN

8. Alanine aminotransferase (ALT) > 3 x ULN

9. Total Bilirubin > 1.5 x ULN

14. 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

15. If the participant has been in a recent experimental trial, these must have been
completed not less than 60 days prior to this study.

Study design
Purpose of the study
Other
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
30/09/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/09/2024
Actual
Sample size
Target
140
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,QLD,VIC,WA
Recruitment hospital [1] 0 0
Paratus Clinical Canberra - Canberra
Recruitment hospital [2] 0 0
Campbelltown Hospital - Campbelltown
Recruitment hospital [3] 0 0
Royal Prince Alfred Hospital - Camperdown
Recruitment hospital [4] 0 0
Liverpool Hospital - Liverpool
Recruitment hospital [5] 0 0
Genesis Research Services - Newcastle
Recruitment hospital [6] 0 0
BJC Health - Parramatta
Recruitment hospital [7] 0 0
Westmead Hospital - Westmead
Recruitment hospital [8] 0 0
Princess Alexandra Hospital - Woolloongabba
Recruitment hospital [9] 0 0
Western Health - St. Albans
Recruitment hospital [10] 0 0
Latrobe Regional Hospital - Traralgon
Recruitment hospital [11] 0 0
Linear Clinical Trials - Nedlands
Recruitment postcode(s) [1] 0 0
2606 - Canberra
Recruitment postcode(s) [2] 0 0
2560 - Campbelltown
Recruitment postcode(s) [3] 0 0
2050 - Camperdown
Recruitment postcode(s) [4] 0 0
2170 - Liverpool
Recruitment postcode(s) [5] 0 0
2292 - Newcastle
Recruitment postcode(s) [6] 0 0
2150 - Parramatta
Recruitment postcode(s) [7] 0 0
2145 - Westmead
Recruitment postcode(s) [8] 0 0
4102 - Woolloongabba
Recruitment postcode(s) [9] 0 0
3021 - St. Albans
Recruitment postcode(s) [10] 0 0
3844 - Traralgon
Recruitment postcode(s) [11] 0 0
6009 - Nedlands
Recruitment outside Australia
Country [1] 0 0
New Zealand
State/province [1] 0 0
Auckland
Country [2] 0 0
New Zealand
State/province [2] 0 0
Nelson

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Solarea Bio, Inc
Address
Country

Ethics approval
Ethics application status

Summary
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).
Trial website
https://clinicaltrials.gov/ct2/show/NCT06005220
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Maureen Stanley
Address 0 0
Southern Star Research Pty Ltd.
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Eric Schott
Address 0 0
Country 0 0
Phone 0 0
585-704-8069
Fax 0 0
Email 0 0
eschott@solareabio.com
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT06005220