Probiotics in Adults With Rheumatoid Arthritis

NCT ID
NCT07304505
Registry status
Recruiting
Study type
Interventional
Phase
Not applicable
Sponsor
Ancilia Biosciences
Conditions
Rheumatoid Arthritis (RA)

Overview

ClinicalTrials.gov lists this study as Recruiting.

Official title: An Open-Label Exploratory Analysis of Commercial Probiotics in Adults With Rheumatoid Arthritis

Enrollment: 50 participants (Estimated).

What is being studied

  • Dietary supplement: Align Extra Strength Probiotic Supplement

Who may be eligible

Ages
18 Years to no maximum
Sex
All
Healthy volunteers accepted
No

ClinicalTrials.gov lists the following eligibility criteria.

Inclusion Criteria: 1. Be able to give written informed consent. 2. Be 18 years or older. 3. Clinical diagnosis of rheumatoid arthritis (RA) for more than 6 months. 4. Have been on stable RA treatment for 3 months and are expected to remain on stable RA treatment during the study. 5. Willing to consume the study product daily for the duration of the study. Exclusion Criteria: 1. Participants who are pregnant or wish to become pregnant during the study or who are lactating and/or currently breastfeeding. 2. Participants currently of biological childbearing potential, but not using a continuous effective method of contraception, as outlined below: 1. 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 Study Product in cases where Participant discontinues the study prematurely. (Participants utilising this method must agree to use an alternate method of contraception if they should become sexually active and will be queried on whether they have been abstinent in the preceding two weeks when they present to the clinic for the final visit). 2. Has a male sexual partner who is surgically sterilised prior to the Screening Visit and is the only male sexual partner for that Participant. 3. Sexual partner(s) is/are exclusively female. 4. 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 one week prior to and one week following the end of the study. 5. 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 of the study. 3. Has a history of drug and/or alcohol abuse. 4. Has food allergies or other issues with foods that would preclude intake of the Study Products including milk and soy allergies. 5. 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 judged by the investigator on the basis of medical history and routine laboratory test results. Excluded health conditions include: 1. history of mixed connective tissue disease or overlap syndrome (Systemic lupus erythematosus (SLE), Systemic sclerosis (scleroderma), Polymyositis/ dermatomyositis) 2. Prior history or current inflammatory joint disease other than RA (such as psoriatic arthritis, gout, reactive arthritis, Lyme disease). 3. Diagnosed gastrointestinal disease 4. Gastrointestinal surgery, excluding cholecystectomy and appendectomy in the last five years. 5. Renal failure 6. Liver cirrhosis 6. 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. Prohibited medications include: a. Antibiotics 7. 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 interpretation of the study results. Prohibited supplements include: a. Probiotics 8. Current or recent (in the past 2-weeks) use of yoghurts containing probiotics. 9. 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. 10. 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 to ensure the integrity of the results.

Study locations

1 study location is listed.

Recruiting site status is explicitly provided for 1 location; 1 is listed as Recruiting.

Countries: United States

  • Illinois, United States: 1

Sample of listed locations

  • Atlantia Clinical Trials — Chicago, Illinois, 60611, United States — Recruiting

Study details

Start date
November 13, 2025
Primary completion date
March 1, 2026
Completion date
March 1, 2026
First posted
December 26, 2025

Source and update information

Source
ClinicalTrials.gov
NCT ID
NCT07304505
Registry last updated
December 31, 2025
QualifiedStudies registry data refreshed
October 2, 2026
QualifiedStudies record fetched
October 2, 2026

View NCT07304505 on ClinicalTrials.gov

Trial information can change. Confirm current study details with the study team or the registry.

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