Oral FMT (Fecal Microbial Transplant) in Subjects with Multiple Sclerosis

NCT04096443 | Active Not Recruiting Early Phase 1 DMC FDA Drug

• 1 other identifier: 2018-09
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this pilot study is to determine whether fecal microbial transplant (FMT) has the potential to be an effective, safe and tolerable therapy for the treatment of multiple sclerosis (MS). The investigators plan to gather preliminary data in a small cohort of 10 to 15 adults with MS.

Conditions

Multiple Sclerosis

Keywords

Fecal microbial transplant; FMT; Pilot study

Outcome Measures

Primary Outcomes (1)

• Change in engraftment of donor microbiome in stool samples

  Evidence of engraftment as measured by 16s rRNA microbiome sequencing

  Pre-FMT and 4 time points post-FMT (3-7 days, 10-15 days, 40-45 days, 100-110 days)

Secondary Outcomes (7)

• Change in immune markers in blood samples assessed using assays of lymphocyte phenotyping and intracellular cytokines

  Pre-FMT and 2 time points post-FMT (40-45 days, 100-110 days)

• Change in neurological status using Kurtzke Functional Systems Scale (FSS)

  Pre-FMT and 4 time points post-FMT (3-7 days, 10-15 days, 40-45 days, 100-110 days)

• Change in neurological status using Kurtzke Expanded Disability Status Scale (EDSS)

  Pre-FMT and 4 time points post-FMT (3-7 days, 10-15 days, 40-45 days, 100-110 days)

• Change in self-reported health-related quality of life assessed using the Health Status Questionnaire Short-Form 36 (SF-36)

  Pre-FMT and 3 time points post-FMT (10-15 days, 40-45 days, 100-110 days)

• Change in self-reported mental health status assessed using Mental Health Inventory (MHI)

  Pre-FMT and 3 time points post-FMT (10-15 days, 40-45 days, 100-110 days)

Study Arms (1)

Intervention

EXPERIMENTAL

Fecal microbial transplant capsules

Biological: Fecal microbial transplant (FMT)

Interventions

Fecal microbial transplant (FMT) BIOLOGICAL

Oral fecal microbial transplant capsules

Intervention

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Diagnosis of clinically definite multiple sclerosis (CDMS) by 2017 McDonald Criteria
• Ages between 18 and 55 years, inclusive;
• Expanded Disability Status Score (EDSS) between 1.0 and 6.5.
• Currently untreated with any disease-modifying therapy (DMT) or currently being treated with glatiramer acetate or interferon beta.
• Ability to travel to Griffin Hospital for 8 visits over a 5-month period

You may not qualify if:

• Inability to give consent;
• Non-fluency in English;
• Inability to adhere to the protocol;
• Inability (e.g., dysphagia) to or unwillingness to swallow capsules;
• Active gastrointestinal infection at the time of enrollment;
• Use of antibiotics or corticosteroids within three months of study entry;
• Requiring or anticipating antibiotic use during the four weeks after study entry;
• MS relapse within one month of study entry;
• Previous use of any of the following FDA-approved disease-modifying drugs within 12 months of study entry, including natalizumab, fingolimod, siponimod, ozanimod, teriflunomide, diroximel, ocrelizumab, ofatumumab, and/or dimethyl fumarate; or any of the following off-label therapies, including rituximab and cyclophosphamide;
• Any previous use of the following FDA-approved DMTs, including mitoxantrone, alemtuzumab, and cladribine;
• IV immunoglobulin or plasma exchange within six months prior to study entry;
• Known or suspected toxic megacolon and/or known small bowel ileus;
• Major gastrointestinal surgery (e.g., significant bowel resection) within 3 months prior to enrollment (this does not include appendectomy or cholecystectomy);
• History of total colectomy or bariatric surgery;
• Concurrent intensive induction chemotherapy, radiation therapy or biological treatment for active malignancy;

Sponsors & Collaborators

• Griffin Hospital: lead
• Yale-Griffin Prevention Research Center: collaborator

Study Sites (1)

Griffin Hospital

Derby, Connecticut, 06418, United States

Location

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Joseph B Guarnaccia, MD

  Griffin Hospital

  PRINCIPAL INVESTIGATOR

• Frederick Browne, MD

  Griffin Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Pre/post pilot investigational study

Study Record Dates

• First Submitted: August 7, 2019
• First Posted: September 19, 2019
• Study Start: October 28, 2019
• Primary Completion: September 21, 2023
• Study Completion: December 30, 2024
• Last Updated: October 18, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)