Fecal Microbial Transplantation for Rheumatoid Arthritis Trial (FeMiTRA)

August 19, 2024 updated by: Lawson Health Research Institute
This clinical trial will investigate the effects of capsules containing stool from healthy donors, called fecal microbial transplant (FMT), in rheumatoid arthritis patients.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This is a randomized double-blind placebo-controlled proof-of-concept trial. A total of 30 RA patients will be asked to join the study. They will be randomized to receive capsular FMT + standard of care or placebo + standard of care. There will be four study visits in total: Baseline, FMT administration, 6- and 12-week follow-up visits. Follow-up visits will consist of assessment by a rheumatologist, completion of surveys, and collection of biologic samples.

Samples for the study are stool, urine and blood. Blood and fecal samples will be collected at baseline, 6 weeks and 12 weeks. Urine samples will be collected at baseline and 6 weeks.

Study Type

Interventional

Enrollment (Estimated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 18-years old or older
  • RA diagnosis by ACR/EULAR criteria [26]
  • Positive for the RA-associated antibodies, anti-citrullinated protein/peptide antibodies (ACPA) and/or rheumatoid factor (RF)
  • Stable RA therapy > 6 months
  • Patient in remission or low disease activity by DAS28
  • Consents to study

Fecal Donor Inclusion Criteria:

  • A healthy donor who has a normal body mass index (BMI of 18.5-30) and who satisfies the following criteria will be selected from a pool of donors available in the Infectious Diseases clinic at St. Joseph's Hospital supervised by Dr. Silverman and screened for all transmissible agents. at the Microbiology and Immunology lab at St. Joseph's Hospital under Dr. Silverman for the study and screened for transmissible agents.

Exclusion Criteria:

  • Pregnant or breastfeeding
  • Current or recent [in the last 60 days] exposure to high dose oral (>30 mg of prednisone daily or equivalent), IV corticosteroids, biologic therapies or JAKi.
  • Patients who require inhaled steroids or local steroid injections are not excluded from the study
  • Has a diagnosis of immunodeficiency (HIV, transplantation, or autoimmune disease other than RA requiring immunosuppressive therapies), or currently receiving systemic steroid therapy (>10 mg prednisone daily or equivalent)
  • Received rituximab or other chemotherapeutic agent in the last 2 years.
  • Expected to require any other form of systemic or localized anti-neoplastic therapy while on study
  • Has a known history of a hematologic malignancy, primary brain tumor or sarcoma, or of another primary solid tumor, unless the patient has undergone potentially curative therapy with no evidence of that disease for five years. NOTE: This time requirement also does not apply to patients who underwent successful definitive resection of basal or squamous cell carcinoma of the skin, superficial bladder cancer, in situ cancers including cervical cancer, breast cancer, melanoma, or other in situ cancers.
  • Ongoing use of antibiotics/anti-virals or previous use of antibiotics/anti-virals in the last 3 months prior to the FMT procedure
  • Has an active infection requiring systemic therapy or requiring hospital admission in last 3 months.
  • Presence of a chronic intestinal disease (e.g. Celiac disease, malabsorption, colonic tumor, IBD)
  • Presence of absolute contra-indications to FMT administration
  • Toxic megacolon
  • Anaphylactic allergic reactions to food (e.g. shellfish, nuts, seafood, eggs)
  • Has serious uncontrolled concomitant illnesses, such as: cardiovascular disease (uncontrolled congestive heart failure, hypertension, cardiac ischemia, myocardial infarction, and severe cardiac arrhythmia), severe obstructive or restrictive pulmonary diseases, cirrhosis or ALT>100, renal disease with GFR<50 and uncontrolled psychiatric illness.
  • Patient has received a live vaccine within 4 weeks prior to the first dose of treatment
  • Insulin-dependent diabetes
  • Previous bariatric surgery
  • Chronic neutropenia (<0.5) Currently participating in another clinical trial

Fecal Donor Exclusion Criteria:

  • Any underlying metabolic disease including; hypertension, hyperlipidemia, diabetes, insulin insensitivity, atherosclerosis
  • A history of any gastrointestinal or liver disorders or cancers. Including but not limited to; gastroesophageal reflux, peptic ulcer disease, celiac disease, inflammatory bowel disease (Crohn's disease or ulcerative colitis), microscopic colitis, motility disorders (including gastroparesis and irritable bowel syndrome) diverticular disease
  • Previous surgery to the intestine, liver or gallbladder (except remote appendectomy)
  • History of any malignancy
  • Use within 3 months of any antibiotics
  • Hospitalization within 3 months
  • Recent travel to a developing country (within 3 months).
  • New Sexual Partner (within 3 months)
  • Street drug use, family history of diabetes, early onset coronary disease or gastrointestinal or liver disease, colon cancer, familial malignancy
  • Psychiatric history (major affective disorder, psychotic illness, ongoing use of any psychiatric medications)
  • Any positive laboratory results for a transmissible pathogen
  • Alcohol intake with a cut off value of <10g/d in women and <20g/d in men
  • Currently participating in another clinical trial that may alter fecal composition.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Fecal Microbial Transplant
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.
Drug: Fecal Microbial transplant
Fecal microbial transplant will be investigated for its effect on gut bacterial composition in patients with rheumatoid arthritis.
Other Names:
  • FMT Capsules
Placebo Comparator: Placebo
Participants will be administered 35-40 placebo capsules orally with water. This will only occur once and takes approximately 30 minutes.
Other: Placebo capsules
The placebo capsules will not contain FMT but will have the same appearance.
Other Names:
  • Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Intestinal Permeability
Time Frame: Baseline and 6 weeks
A blood sample will be collected for bacterial DNA analysis.
Baseline and 6 weeks
Change in Intestinal Permeability
Time Frame: Baseline and 6 weeks
A urine sample will be collected to measure the lactulose to mannitol ratio.
Baseline and 6 weeks
Change in RA-associated autoantibodies
Time Frame: Baseline, 6 weeks and 12 weeks
A blood sample will be collected to measure RA-associated autoantibodies.
Baseline, 6 weeks and 12 weeks
Adverse Events
Time Frame: Baseline
Adverse events will be evaluated at every study visit. Participants will also be instructed to contact study staff by phone if they experience an adverse event in between study visits.
Baseline
Adverse Events
Time Frame: FMT treatment visit
Adverse events will be evaluated at every study visit. Participants will also be instructed to contact study staff by phone if they experience an adverse event in between study visits.
FMT treatment visit
Adverse Events
Time Frame: 6 weeks post-treatment
Adverse events will be evaluated at every study visit. Participants will also be instructed to contact study staff by phone if they experience an adverse event in between study visits.
6 weeks post-treatment
Adverse Events
Time Frame: 12 weeks post-treatment
Adverse events will be evaluated at every study visit. Participants will also be instructed to contact study staff by phone if they experience an adverse event in between study visits.
12 weeks post-treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Fecal Microbial Composition
Time Frame: Baseline, 6 weeks and 12 weeks
Stool samples will be collected to determine fecal microbial composition using 16S-RNA sequencing.
Baseline, 6 weeks and 12 weeks
Change in C-Reactive Protein
Time Frame: Baseline, 6 weeks and 12 weeks.
Blood sample will be collected to measure CRP levels.
Baseline, 6 weeks and 12 weeks.

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain Visual Analog Scale
Time Frame: Baseline, 6 weeks and 12 weeks
Change in pain will be measured using a visual analog scale.
Baseline, 6 weeks and 12 weeks
Fatigue
Time Frame: Baseline, 6 weeks and 12 weeks
Change in fatigue will be measured with a visual analog scale.
Baseline, 6 weeks and 12 weeks
Sleep
Time Frame: Baseline, 6 weeks and 12 weeks
Change in sleep will be measured with a visual analog scale.
Baseline, 6 weeks and 12 weeks
Change in RA disease activity
Time Frame: Baseline, 6 weeks and 12 weeks
RA disease activity will be measured using the disease activity score-28 (DAS28).
Baseline, 6 weeks and 12 weeks
Change in RA disease activity
Time Frame: Baseline, 6 weeks and 12 weeks
RA disease activity will be measured using the health assessment questionnaire (HAQ).
Baseline, 6 weeks and 12 weeks
Change in RA disease activity
Time Frame: Baseline, 6 weeks and 12 weeks
RA disease activity will be measured using the clinical disease activity index (CDAI).
Baseline, 6 weeks and 12 weeks
Insulin Resistance
Time Frame: Baseline, 6 weeks and 12 weeks
Fasting glucose and insulin will be measured from a blood sample to calculate the Homeostatic Model Assessment for Insulin Resistance (HOMA-IR).
Baseline, 6 weeks and 12 weeks
Blood Pressure
Time Frame: Baseline, 6 weeks and 12 weeks
Systolic and Diastolic blood pressure is part of the standard of care and will be measured at each study visit.
Baseline, 6 weeks and 12 weeks
Body Mass Index
Time Frame: Baseline, 6 weeks and 12 weeks
Body mass index is part of the standard of care and will be measured at each study visit.
Baseline, 6 weeks and 12 weeks
Patient Acceptability of FMT
Time Frame: Baseline, 6 weeks and 12 weeks
Participants will complete an acceptability of therapy survey for FMT. The survey asks them questions about how well the FMT process was explained to them, and how they feel about it. The participant is asked to select one answer per question ranging from :strongly agree" to "strongly disagree"
Baseline, 6 weeks and 12 weeks
Tolerability of DMARD Therapy
Time Frame: Baseline, 6 weeks and 12 weeks
Participants will complete a survey on tolerability of DMARD therapy.
Baseline, 6 weeks and 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Lawson Health Research Institute

Collaborators

St. Joseph's Health Care London

Investigators

  • Principal Investigator: Lillian Barra, MD, MPH, Lawson Health Research Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2023

Primary Completion (Estimated)

August 1, 2025

Study Completion (Estimated)

April 1, 2026

Study Registration Dates

First Submitted

February 15, 2023

First Submitted That Met QC Criteria

March 16, 2023

First Posted (Actual)

March 30, 2023

Study Record Updates

Last Update Posted (Actual)

August 21, 2024

Last Update Submitted That Met QC Criteria

August 19, 2024

Last Verified

August 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FeMiTRA01

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Arthritis

Clinical Trials on Fecal Microbial transplant

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Madagascar

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe