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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).
Enrollment
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Inclusion criteria
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 smoker and/or uses nicotine replacement therapies (including vaping).
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):
Presence of any of the following active conditions at Screening, or within 72 hours of the first administration of study test article:
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:
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):
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.
Primary purpose
Allocation
Interventional model
Masking
140 participants in 2 patient groups, including a placebo group
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Central trial contact
Eric Schott
Data sourced from clinicaltrials.gov
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