Probiotics in Adults With Rheumatoid Arthritis

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

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

Study Overview

• Status: Recruiting
• Conditions: Rheumatoid Arthritis (RA)
• Intervention / Treatment: Dietary supplement: Align Extra Strength Probiotic Supplement

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Stacey Boetto, DNP, FNP-C; Phone Number: 312-535-9440; Email: sboetto@atlantiatrials.com

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Recruiting
      • Atlantia Clinical Trials
      • Contact: Stacey Boetto, DNP, FNP-C; Phone Number: 312-535-9440; Email: sboetto@atlantiatrials.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Probiotic; 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; Bifidobacterium longum subsp. longum 35624™ (50mg): 5 x10^9 (5 billion) live bacteria per capsule

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
RA clinical outcomes	Change from baseline (Day 0) to Day 21, and Day 39 on Rheumatoid Arthritis clinical outcomes as assessed by Clinical Disease Activity Index (CDAI) Total Score based on: Tender joint count, Swollen joint count, Patient Global disease Activity, Evaluator Global disease Activity. CDAI score is the sum of these components, ranging from 0 to 76, where higher scores are worse outcomes.	6 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse events	Occurrence of any adverse events (AEs/SAEs) and/or changes in vital signs (Blood Pressure, Heart Rate, and Temperature) during probiotic administration	6 weeks

Collaborators and Investigators

• Sponsor: Ancilia Biosciences

Study record dates

Study Major Dates

• Study Start (Actual): November 13, 2025
• Primary Completion (Estimated): March 1, 2026
• Study Completion (Estimated): March 1, 2026

Study Registration Dates

• First Submitted: December 12, 2025
• First Submitted That Met QC Criteria: December 12, 2025
• First Posted (Estimated): December 26, 2025

Study Record Updates

• Last Update Posted (Actual): December 31, 2025
• Last Update Submitted That Met QC Criteria: December 24, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: Microbiome; Probiotic
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Arthritis; Joint Diseases; Rheumatic Diseases; Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Skin and Connective Tissue Diseases; Arthritis, Rheumatoid
• Other Study ID Numbers: AFCRO-201

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No