Probiotics in Adults With Rheumatoid Arthritis

NCT07304505 | Recruiting

• 1 other identifier: AFCRO-201
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Rheumatoid Arthritis (RA)

Keywords

Microbiome; Probiotic

Outcome Measures

Primary Outcomes (1)

• Probiotic bacterial colonization

  Change from baseline (Day 0) to Day 39 (including intermediate time points) in the relative abundance and/or detection frequency of the administered probiotic strain in stool

  6 weeks

Secondary Outcomes (1)

• RA clinical outcomes

  6 weeks

Other Outcomes (1)

• Adverse events

  6 weeks

Study Arms (1)

Probiotic

EXPERIMENTAL

6-week daily oral administration of Align Extra Strength Probiotic Supplement, produced by Procter \& Gamble (Bifidobacterium longum subsp. longum 35624™)

Dietary Supplement: Align Extra Strength Probiotic Supplement

Interventions

Align Extra Strength Probiotic Supplement DIETARY_SUPPLEMENT

Bifidobacterium longum subsp. longum 35624™ (50mg): 5 x10\^9 (5 billion) live bacteria per capsule

Probiotic

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify 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 may not qualify 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 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).
• 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 one week prior to and one week following the end of the study.
• 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.
• 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 judged by the investigator on the basis of medical history and routine laboratory test results. Excluded health conditions include:
• 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

Sponsors & Collaborators

• Ancilia Biosciences: lead

Study Sites (1)

Atlantia Clinical Trials

Chicago, Illinois, 60611, United States

RECRUITING

MeSH Terms

Conditions

Arthritis, Rheumatoid

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Central Study Contacts

Stacey Boetto, DNP, FNP-C

CONTACT

312-535-9440; sboetto@atlantiatrials.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 12, 2025
• First Posted: December 26, 2025
• Study Start: November 13, 2025
• Primary Completion: March 1, 2026
• Study Completion: March 1, 2026
• Last Updated: December 31, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)