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?

This trial explores whether a daily probiotic can improve symptoms for people with rheumatoid arthritis (RA). Participants will take the Align Extra Strength Probiotic Supplement for six weeks to assess its impact on their RA. The study includes regular clinic visits and stool sample collection to monitor changes. Individuals with RA for over six months who are on a stable treatment plan might be suitable candidates. As an unphased trial, this study allows participants to contribute to valuable research that could lead to new insights into managing RA symptoms.

Will I have to stop taking my current medications?

You can continue taking your current rheumatoid arthritis medications as long as they have been stable for 3 months and remain stable during the study. However, you must avoid antibiotics and certain supplements like probiotics before and during the study.

What prior data suggests that this probiotic is safe for rheumatoid arthritis patients?

Studies have shown that the Align Extra Strength Probiotic Supplement is generally well-tolerated. It contains Bifidobacterium longum 35624, a beneficial bacterium used to alleviate symptoms of irritable bowel syndrome (IBS), such as bloating and gas. Doctors often recommend this probiotic for digestive health.

In previous research, participants taking this probiotic did not report major safety concerns, and most did not experience serious side effects. Some might notice mild digestive changes, like increased gas or altered bowel habits, especially when starting the supplement. These effects typically subside after a few days.

Overall, the Align probiotic is considered safe based on its use for other conditions. If concerns arise, consulting a healthcare provider is advisable. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Most treatments for rheumatoid arthritis focus on reducing inflammation and suppressing the immune system, often using drugs like methotrexate or biologics. However, Align Extra Strength Probiotic Supplement is unique because it utilizes a specific strain of probiotic, Bifidobacterium longum subsp. longum 35624™. This strain is believed to help balance gut bacteria, which may have a favorable effect on immune system regulation and inflammation reduction. Researchers are excited about this treatment because it offers a potentially safer, non-drug alternative that targets gut health, which is an emerging area of interest in managing autoimmune conditions like rheumatoid arthritis.

What evidence suggests that this probiotic is effective for rheumatoid arthritis?

Research shows that probiotics like Bifidobacterium longum 35624, found in Align Extra Strength, might help with gut-related issues. In studies involving individuals with irritable bowel syndrome (IBS), this probiotic reduced symptoms and improved quality of life. Although less research exists on its effects on rheumatoid arthritis, this trial will explore its potential benefits for the condition. The probiotic's support for gut health might prove helpful, as healthy gut bacteria are believed to influence inflammation, a major factor in rheumatoid arthritis. ^{1 3 6 7 8}

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

Citations

1.

clinicaltrials.gov

clinicaltrials.gov/study/NCT07304505

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 ...

2.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC8891724/

Effect of Bifidobacterium longum 35624 on disease severity ...

Thirty days of treatment with B. longum 35624 reduces disease severity and improves the quality of life of patients with IBS, particularly those with the most ...

3.

pgsciencebehind.com

pgsciencebehind.com/en-ca/align/clinical-data

Align® Clinical Data for Healthcare Professionals

20% more patients reported adequate relief of global IBS symptoms after 4 weeks of Align® Bifidobacterium 35624™ treatment compared to placebo1† ...

4.

alignprobiotics.com

alignprobiotics.com/en-us/products/probiotics-digestive-support/extra-strength-probiotic-supplement

Align Extra Strength^ Probiotic Supplement

Align Extra Strength Probiotic Supplement adds healthy bacteria to your gut to help promote gut health.

5.

amazon.com

amazon.com/Align-Probiotic-Supplement-Recommended-Probiotics/dp/B07K98GCXM

Amazon.com: Align Probiotic, Extra Strength ...

Bifidobacterium longum subsp. longum 35624TM† 17.5 mg†† † Contains 5 x 109 (five billion) live bacteria/ CFU when manufactured, and provides an effective ...

6.

alignprobiotics.com

alignprobiotics.com/en-us/faq

FAQs on Usage, Safety & Storage | Align Probiotic

Get answers to most frequestly asked questions about Align Probiotics, its' usage, dosage and safety. Read more!

7.

smartlabel.pg.com

smartlabel.pg.com/en-ca/00056100078722.html

Align Probiotic Digestive Support Capsules, #1 Doctor ...

#1 Doctor Recommended Probiotic Brand‡, Helps Relieve Symptoms of Irritable Bowel Syndrome (IBS) such as Bloating, Gas, and Abdominal Discomfort, 14 Capsules

8.

pgsciencebehind.com

pgsciencebehind.com/en-ca/align/faqs

Align® FAQs for Healthcare Professionals

Align is a daily probiotic supplement that helps support gastrointestinal health. Align Digestive Support (Bifidobacterium 35624™) helps relieve and manage IBS ...