Probiotics for Rheumatoid Arthritis

Overseen By Stacey Boetto, DNP, FNP-C

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Ancilia Biosciences

Must not be taking: Antibiotics, Probiotics

Disqualifiers: Pregnancy, Drug abuse, Food allergies, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

Duration: 6 weeks

50 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

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

Are You a Good Fit for This Trial?

This trial is for adults with Rheumatoid Arthritis. Participants will take a daily probiotic for 6 weeks and provide fecal samples regularly. They must be able to visit the clinic at specific times.

Inclusion Criteria

I have been on a stable rheumatoid arthritis treatment for 3 months.

Be able to give written informed consent

Willing to consume the study product daily for the duration of the study

Exclusion Criteria

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

I am not on any medication that could affect the study results.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a 6-week daily administration of a probiotic

6 weeks

3 visits (in-person) at Baseline, Week 3, and Week 6

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Align Extra Strength Probiotic Supplement

Trial Overview

The study tests if Align Extra Strength Probiotic Supplement affects clinical outcomes in Rheumatoid Arthritis patients over a period of 6 weeks, with regular checkups and sample collections.

How Is the Trial Designed?

Group I: Probiotic Experimental Treatment 1 Intervention

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

Who Is Running the Clinical Trial?

Ancilia Biosciences

Lead Sponsor