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Fecal Microbial Transplant

Oral FMT for Multiple Sclerosis

Phase < 1
Waitlist Available
Led By Joseph B Guarnaccia, MD
Research Sponsored by Griffin Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Ages between 18 and 55 years, inclusive
Expanded Disability Status Score (EDSS) between 1.0 and 6.5
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day of fmt procedure and 5 time points post-fmt (1 day, 3-7 days, 10-15 days, 40-45 days, 100-110 days), or any time the study team is contacted by subjects who report adverse side effects
Awards & highlights

Study Summary

This trial is testing whether FMT, or transplanting stool from a healthy person into the intestine of someone with MS, is effective, safe, and tolerable.

Who is the study for?
Adults aged 18-55 with a definite diagnosis of multiple sclerosis (MS) and an EDSS score between 1.0 and 6.5 can join this trial. They should not be on most MS drugs, but glatiramer acetate or interferon beta is okay. Participants must speak English, give consent, swallow capsules, and commit to several visits over five months.Check my eligibility
What is being tested?
This pilot study tests if fecal microbial transplant (FMT), given orally via capsules, could be a safe and effective treatment for MS in adults. The study will collect initial data from a small group of participants to assess the potential benefits.See study design
What are the potential side effects?
Potential side effects are not detailed here but may include digestive discomfort or changes in bowel habits due to the nature of FMT as it involves introducing new gut bacteria.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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You are between 18 and 55 years old.
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Your Expanded Disability Status Score (EDSS) is between 1.0 and 6.5.
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You are not currently taking any disease-modifying therapy (DMT), or you are only taking glatiramer acetate or interferon beta.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day of fmt procedure and 5 time points post-fmt (1 day, 3-7 days, 10-15 days, 40-45 days, 100-110 days), or any time the study team is contacted by subjects who report adverse side effects
This trial's timeline: 3 weeks for screening, Varies for treatment, and day of fmt procedure and 5 time points post-fmt (1 day, 3-7 days, 10-15 days, 40-45 days, 100-110 days), or any time the study team is contacted by subjects who report adverse side effects for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in engraftment of donor microbiome in stool samples
Secondary outcome measures
Change in immune markers in blood samples assessed using assays of lymphocyte phenotyping and intracellular cytokines
Change in neurological status using Kurtzke Expanded Disability Status Scale (EDSS)
Change in neurological status using Kurtzke Functional Systems Scale (FSS)
+4 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: InterventionExperimental Treatment1 Intervention
Fecal microbial transplant capsules

Find a Location

Who is running the clinical trial?

Yale-Griffin Prevention Research CenterOTHER
3 Previous Clinical Trials
259 Total Patients Enrolled
2 Trials studying Multiple Sclerosis
59 Patients Enrolled for Multiple Sclerosis
Multiple Sclerosis Treatment Center, Derby, ConnecticutOTHER
Griffin HospitalLead Sponsor
24 Previous Clinical Trials
1,529 Total Patients Enrolled
3 Trials studying Multiple Sclerosis
79 Patients Enrolled for Multiple Sclerosis

Media Library

Fecal microbial transplant (FMT) (Fecal Microbial Transplant) Clinical Trial Eligibility Overview. Trial Name: NCT04096443 — Phase < 1
Multiple Sclerosis Research Study Groups: Intervention
Multiple Sclerosis Clinical Trial 2023: Fecal microbial transplant (FMT) Highlights & Side Effects. Trial Name: NCT04096443 — Phase < 1
Fecal microbial transplant (FMT) (Fecal Microbial Transplant) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04096443 — Phase < 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the greatest amount of individuals involved in this clinical exploration?

"Indeed, the clinicaltrials.gov website verifies that this medical trial is still accepting applicants; it was first advertised on October 28th 2019 and last updated November 16th 2022. Researchers are welcoming 15 individuals to join from 1 site."

Answered by AI

Are there any opportunities for participation in this clinical investigation at present?

"Affirmative, clinicaltrials.gov data indicates that this research is currently recruiting participants. It was first posted on October 28th 2019 and the most recent update occurred on November 16th 2022. This study requires 15 individuals from one location to take part in its findings."

Answered by AI

Is this research trial accessible to individuals below the age of sixty?

"According to the trial requirements, individuals aged between 18 and 55 are suitable for enrollment. Meanwhile, there exist 44 trials geared towards minors and 395 aimed at patients 65 or older."

Answered by AI

Would I meet the requirements to join this medical study?

"For this medical experiment, 15 subjects aged 18-55 with clinically definite multiple sclerosis (CDMS) must be selected. Additionally, the patient's Expanded Disability Status Score (EDSS) should fall between 1.0 and 6.5 without being treated by disease-modifying therapy (DMT). Lastly, participants need to have the capacity to travel to Griffin Hospital 8 times over a 5 month period in order to qualify for inclusion."

Answered by AI
~2 spots leftby Mar 2025