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Microbiome Therapy

Fecal Microbial Transplantation for Rheumatoid Arthritis (FeMiTRA Trial)

N/A

Recruiting

Led By Lillian Barra, MD, MPH

Research Sponsored by Lawson Health Research Institute

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

18-years old or older

Positive for the RA-associated antibodies, anti-citrullinated protein/peptide antibodies (ACPA) and/or rheumatoid factor (RF)

Must not have

Previous bariatric surgery

Chronic neutropenia

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, 6 weeks and 12 weeks

Summary

"This trial will study the impact of taking capsules filled with stool from healthy donors, known as fecal microbial transplant (FMT), on patients with rheumatoid arthritis."

Who is the study for?

This trial is for adults over 18 with rheumatoid arthritis, who have specific RA antibodies and are in remission or have low disease activity. They must be on stable RA therapy for more than 6 months and agree to the study's terms. A healthy donor with a normal BMI will provide stool samples.

What is being tested?

The trial tests if swallowing capsules containing stool from healthy donors (fecal microbial transplant) can benefit rheumatoid arthritis patients compared to placebo capsules without active ingredients.

What are the potential side effects?

Potential side effects of fecal microbial transplantation may include digestive discomfort, bloating, diarrhea, or infection due to transferred microbes. The exact side effects will be monitored throughout the trial.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

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I have antibodies linked to rheumatoid arthritis.

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My rheumatoid arthritis treatment has been stable for over 6 months.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have had weight loss surgery in the past.

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I have a long-term low white blood cell count.

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I have recently taken high dose steroids, biologic therapies, or JAK inhibitors.

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I have no health conditions that prevent me from receiving FMT.

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I have not received a live vaccine in the last 4 weeks.

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I use insulin for my diabetes.

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I have an immune system disorder or am currently on steroid treatment.

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I have received rituximab or chemotherapy in the past 2 years.

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I have a history of cancer.

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I have been diagnosed with toxic megacolon.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, 6 weeks and 12 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, 6 weeks and 12 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 6 weeks and 12 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Adverse Events

Change in Intestinal Permeability

Change in RA-associated autoantibodies

Secondary study objectives

Change in C-Reactive Protein

Change in Fecal Microbial Composition

Other study objectives

Blood Pressure

Body Mass Index

Change in RA disease activity

+6 more

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Fecal Microbial TransplantExperimental Treatment1 Intervention

Participants will be administered 35-40 FMT capsules orally with water, for a total dose of 80-100g. This will only occur once and takes approximately 30 minutes.

Group II: PlaceboPlacebo Group1 Intervention

Participants will be administered 35-40 placebo capsules orally with water. This will only occur once and takes approximately 30 minutes.

0 / 13Eligibility criteria met