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

  • STATUS
    Recruiting
  • End date
    Dec 30, 2022
  • participants needed
    15
  • sponsor
    Griffin Hospital
Updated on 22 March 2022
interferon
disease or disorder
glatiramer acetate

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.

Description

The specific aims are to:

  1. Determine the tolerability of a single dose of 30 capsules in a group of adults with MS
  2. Determine whether any unexpected outcomes arise in participants who successfully complete an FMT procedure consisting of a single dose of 30 capsules
  3. Determine whether successfully completed FMT leads to engraftment of donor microbiome in participants
  4. If the FMT leads to engraftment of donor microbiome in participants, determine whether participants revert back to previous microbiome profiles, and if so, at what time point
  5. Determine whether engrafted species following the FMT, if detected, result in any changes in immune or metabolomic parameters relative to baseline
  6. Determine whether the FMT has any adverse impact, relative to baseline, on study participants' self-reported levels of fatigue, mental well-being, and health-related qualify of life
  7. Determine whether the FMT has any adverse impact, relative to baseline, on study participants' neurological status, relative to baseline

The study population will consist of adults with clinically definite MS who are currently untreated with any disease-modifying therapy or are being treated with glatiramer acetate or interferon beta. The research team will offer study participants a single FMT procedure in the form of 30 oral capsules which contain fecal material. Study participants will visit Griffin Hospital facilities 8 times. The first visit will involve a clinical screening. Of the 7 remaining visits, 6 will involve data collection and one will involve the FMT procedure.

Details
Condition Multiple Sclerosis
Treatment Fecal microbial transplant (FMT)
Clinical Study IdentifierNCT04096443
SponsorGriffin Hospital
Last Modified on22 March 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Diagnosis of clinically definite multiple sclerosis (CDMS) by 2017 McDonald Criteria
Ages between 18 and 40 years, inclusive
Expanded Disability Status Score (EDSS) between 1.0 and 5.5
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

Exclusion Criteria

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, teriflunomide, and/or dimethyl fumarate
Any previous use of the following FDA-approved DMTs, including mitoxantrone, alemtuzumab, ocrelizumab, or any of the following off-label therapies, including rituximab and cyclophosphamide
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
Anticipated life expectancy of less than six months
Concomitant other known autoimmune diseases
Concomitant pulmonary, cardiac, gastrointestinal (except as noted above) (Crohns, Colitis, inflammatory bowel, intestinal blockage), hepatic, dermatological or genitourinary disease
Moderate to severe dysphagia
History of alcohol abuse, as defined by the following criteria
Men: 5 or more alcoholic beverages per session or day, or 15 or more per week
Women: 4 or more alcoholic beverages per session or day, or 8 or more per
week
History of illicit drug abuse, e.g., of cocaine, heroin, PCP, and/or narcotic substances
Marijuana use within the past six months prior to study enrollment, whether for medical reasons or recreational purposes
History of using tobacco products within the past year prior to study enrollment
Grade 1 or greater lymphopenia, as measured at baseline/clinical screening
Liver Function Tests (LFTs) greater than 1½ times upper limits of normal, as measured at baseline/clinical screening
History of use of FMT or microbiome-based products (excluding probiotics) at any time, excluding this study
History of severe anaphylactic or anaphylactoid food allergy
History of solid organ transplantation
Risk for Cytomegalovirus (CMV) or Epstein Barr virus (EBV) associated disease (at investigator's discretion, e.g., immunocompromised and negative (immunoglobulin gamma) IgG testing for CMV or EBV)
Women who are pregnant, lactating, planning to become pregnant, and/or not using an effective method of contraception (women of childbearing potential will undergo a pregnancy test, and will be excluded from the study if results are positive)
Any allergies to neomycin or similar antibiotics such as amikacin (Amikin), gentamicin (Garamycin), kanamycin (Kantrex), paromomycin (Humatin, Paromycin), streptomycin, or tobramycin (Nebcin, Tobi)
Any condition that would jeopardize the safety or rights of the subject, would make it unlikely for the subject to complete the study, or would confound the study results
Clear my responses

How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact

site

0/250

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Loading...

Browse trials for

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 

 • 

Private

Reply by • Private
Loading...

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.
Loading...

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note