Fecal Microbial Transplantation for Rheumatoid Arthritis Trial

NCT05790356 | Recruiting

• 1 other identifier: FeMiTRA01
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

This clinical trial will investigate the effects of capsules containing stool from healthy donors, called fecal microbial transplant (FMT), in rheumatoid arthritis patients.

Conditions

Arthritis; Arthritis, Rheumatoid; Fecal Microbiota Transplantation

Keywords

Arthritis; Rheumatoid; Rheumatoid Arthritis; clinical trial; fecal matter transplantation; fecal matter transplant; faecal; autoimmune; proof of concept

Outcome Measures

Primary Outcomes (7)

• Change in Intestinal Permeability

  A blood sample will be collected for bacterial DNA analysis.

  Baseline and 6 weeks

• Change in Intestinal Permeability

  A urine sample will be collected to measure the lactulose to mannitol ratio.

  Baseline and 6 weeks

• Change in RA-associated autoantibodies

  A blood sample will be collected to measure RA-associated autoantibodies.

  Baseline, 6 weeks and 12 weeks

• Adverse Events

  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

  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

  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

  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 Outcomes (2)

• Change in Fecal Microbial Composition

  Baseline, 6 weeks and 12 weeks

• Change in C-Reactive Protein

  Baseline, 6 weeks and 12 weeks.

Other Outcomes (11)

• Pain Visual Analog Scale

  Baseline, 6 weeks and 12 weeks

• Fatigue

  Baseline, 6 weeks and 12 weeks

• Sleep

  Baseline, 6 weeks and 12 weeks

Study Arms (2)

Fecal Microbial Transplant

EXPERIMENTAL

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

Placebo

PLACEBO COMPARATOR

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

Other: Placebo capsules

Interventions

Fecal Microbial transplant DRUG

Fecal microbial transplant will be investigated for its effect on gut bacterial composition in patients with rheumatoid arthritis.

Also known as: FMT Capsules

Fecal Microbial Transplant

Placebo capsules OTHER

The placebo capsules will not contain FMT but will have the same appearance.

Also known as: Placebo

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's: lead
• St. Joseph's Health Care London: collaborator

Study Sites (1)

St. Joseph's Health Care London

London, Ontario, N6A 4V2, Canada

RECRUITING

Related Publications (31)

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• Wang S, Xu M, Wang W, Cao X, Piao M, Khan S, Yan F, Cao H, Wang B. Systematic Review: Adverse Events of Fecal Microbiota Transplantation. PLoS One. 2016 Aug 16;11(8):e0161174. doi: 10.1371/journal.pone.0161174. eCollection 2016.

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MeSH Terms

Conditions

Arthritis; Arthritis, Rheumatoid

Interventions

Fecal Microbiota Transplantation

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Biological Therapy; Therapeutics

Study Officials

• Lillian Barra, MD, MPH

  London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lillian Barra, MD, MPH

CONTACT

519-646-6100; Lillian.Barra@sjhc.london.on.ca

Jeremy Burton, PhD

CONTACT

519-646-6100; jeremy.burton@LawsonResearch.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Neither the participants or the investigator will know which treatment arms participants have been assigned to. This information can be obtained quickly from pharmacy if needed.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized, double-blind, placebo-controlled proof-of-concept study.

Study Record Dates

• First Submitted: February 15, 2023
• First Posted: March 30, 2023
• Study Start: August 1, 2023
• Primary Completion: August 1, 2025
• Study Completion: April 1, 2026
• Last Updated: August 21, 2024

Record last verified: 2024-08

Locations

CA (1)