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New treatment option for Rheumatoid Arthritis (RA)
Official title Probiotics in Adults With Rheumatoid Arthritis
ClinicalTrials.gov ID: NCT07304505
What this study is testing
- What it's testing
- The goal of this clinical study is to collect data on the effect of probiotic administration on clinical outcomes in rheumatoid arthritis patients. Participants will: Have a 6-week daily administration of a probiotic Collect fecal samples every other day during the first 3 weeks of the study and twice weekly over the last 3 weeks Visit the clinic at Baseline, Week 3 and Week 6 for checkup and testing
- Time commitment: about 3 weeks
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Be able to give written informed consent.
- Be 18 years or older.
- Clinical diagnosis of rheumatoid arthritis (RA) for more than 6 months.
- Have been on stable RA treatment for 3 months and are expected to remain on stable RA treatment during the study.
- Willing to consume the study product daily for the duration of the study.
You likely can't join if
- Participants who are pregnant or wish to become pregnant during the study or who are lactating and/or currently breastfeeding.
- Participants currently of biological childbearing potential, but not using a continuous effective method of contraception, as outlined below:
- Complete abstinence from intercourse two weeks prior to administration of the Study Product, throughout the clinical study, until the completion of...
- Has a male sexual partner who is surgically sterilised prior to the Screening Visit and is the only male sexual partner for that Participant.
- Sexual partner(s) is/are exclusively female.
- Use of acceptable method of contraception, such as a spermicide, mechanical barrier (e.g., male condom, female diaphragm), tubal ligation, or...
See the full eligibility criteria
Who can join
- Be able to give written informed consent.
- Be 18 years or older.
- Clinical diagnosis of rheumatoid arthritis (RA) for more than 6 months.
- Have been on stable RA treatment for 3 months and are expected to remain on stable RA treatment during the study.
- Willing to consume the study product daily for the duration of the study.
What rules you out
- Participants who are pregnant or wish to become pregnant during the study or who are lactating and/or currently breastfeeding.
- Participants currently of biological childbearing potential, but not using a continuous effective method of contraception, as outlined below:
- Complete abstinence from intercourse two weeks prior to administration of the Study Product, throughout the clinical study, until the completion of follow-up procedures or for two weeks following discontinuation of the...
- Has a male sexual partner who is surgically sterilised prior to the Screening Visit and is the only male sexual partner for that Participant.
- Sexual partner(s) is/are exclusively female.
- Use of acceptable method of contraception, such as a spermicide, mechanical barrier (e.g., male condom, female diaphragm), tubal ligation, or contraceptive pill. The Participant must be using this method for at least...
- Use of any intrauterine device (IUD) or contraceptive implant. The Participant must have the device inserted at least two weeks prior to the first screening visit, throughout the study, and two weeks following the end...
- Has a history of drug and/or alcohol abuse.
- Has food allergies or other issues with foods that would preclude intake of the Study Products including milk and soy allergies.
- Has any significant acute or chronic coexisting health conditions that would prevent them from fulfilling the study requirements, put the Participant at risk or would confound the interpretation of the study results as...
- history of mixed connective tissue disease or overlap syndrome (Systemic lupus erythematosus (SLE), Systemic sclerosis (scleroderma), Polymyositis/ dermatomyositis)
- Prior history or current inflammatory joint disease other than RA (such as psoriatic arthritis, gout, reactive arthritis, Lyme disease).
- Diagnosed gastrointestinal disease
- Gastrointestinal surgery, excluding cholecystectomy and appendectomy in the last five years.
- Renal failure
- Liver cirrhosis
- Current or recent (in the past 8-weeks) use of a medication that the investigator believes would interfere with the objectives of the study or pose a safety risk or confound the interpretation of the study results...
- Current or recent (in the past 4-weeks) use of prohibited nutritional or non-nutritional supplements that the investigator believes would interfere with the objectives of the study or pose a safety risk or confound the...
- Current or recent (in the past 2-weeks) use of yoghurts containing probiotics.
- Individuals who, in the opinion of the investigator, are considered to be poor attendees or unlikely for any reason to be able to comply with the study.
- Participants may not be participating in other clinical studies. If the participant has previously taken part in an experimental study, the Investigator must ensure sufficient time has elapsed before entry to this study...
The study team makes the final eligibility decision.
Where it's taking place
- Chicago, Illinois, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 3 weeks per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Chicago, Illinois, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.