A Randomised, Double Blind Placebo-controlled Trial Evaluating the Medical Food Synbiotic SBD121, Versus Placebo for the Clinical Dietary Management of Early Rheumatoid Arthritis.

Solarea Bio, Inc22 sites in 4 countries143 target enrollmentSeptember 30, 2023

ConditionsRheumatoid Arthritis

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Rheumatoid Arthritis
Sponsor: Solarea Bio, Inc
Enrollment: 143
Locations: 22
Primary Endpoint: American College of Rheumatology 20 (ACR-20)
Status: Completed
Last Updated: 4 months ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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).

Registry

clinicaltrials.gov

Start Date

September 30, 2023

End Date

October 6, 2025

Last Updated

4 months ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Solarea Bio, Inc

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•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.

Exclusion Criteria

•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

Outcomes

Primary Outcomes

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

Secondary Outcomes

Disease Activity Score 28 - Eosinophil Sedimentation Rate (DAS28 - ESR)(8-weeks, 16-weeks)
Safety by Adverse Events(16-weeks)
American College of Rheumatology 70 (ACR-70)(8-weeks, 16-weeks)
Disease Activity Score 28 - C-Reactive Protein (DAS28 - CRP)(8-weeks, 16-weeks)
Tolerability by GITQ(16-weeks)
American College of Rheumatology 50 (ACR-50)(8-weeks, 16-weeks)
American College of Rheumatology 20 (ACR-20)(8 weeks)
Disease Activity Score 28 - C-Reactive Protein - Low Disease Activity (DAS28 - CRP LDA)(8-weeks, 16-weeks)
Disease Activity Score 28 - C-Reactive Protein - Remission (DAS28 - CRP Remission)(8-weeks, 16-weeks)
C-Reactive Protein (CRP)(8-weeks, 16-weeks)
Zonulin(8-weeks, 16-weeks)
Disease Activity Score 28 - Eosinophil Sedimentation Rate - Low Disease Activity (DAS28 - ESR - LDA)(8-weeks, 16-weeks)
Disease Activity Score 28 - Eosinophil Sedimentation Rate - Remission (DAS28 - ESR Remission)(8-weeks, 16-weeks)
Reduce or discontinue use of oral NSAIDs(8-weeks, 16-weeks)
Eosinophil Sedimentation Rate (ESR)(8-weeks, 16-weeks)
Reduce or discontinue use of oral corticosteroids(8-weeks, 16-weeks)