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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
Be between 18 and 65 years old
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
No Placebo-Only Group
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.
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.
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.
Timeline
Screening ~ 3 weeks3 visits
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
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
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change in engraftment of donor microbiome in stool samples
Secondary study objectives
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 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
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
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You had a multiple sclerosis relapse within one month before the study starts.You have previously used certain FDA-approved disease-modifying therapies.You have taken antibiotics or corticosteroids within the last three months before the study starts.You can't swallow pills or don't want to.You currently have a stomach or intestine infection.You have received IV immunoglobulin or plasma exchange in the six months before the study starts.You have a condition called toxic megacolon or a blockage in your small intestine.You have had surgery to remove your entire colon or for weight loss.You have a history of drinking alcohol excessively.You have a history of using illegal drugs.You have low levels of a type of white blood cells called lymphocytes.Your liver function tests show results that are higher than normal by 1½ times or more.You have used FMT or microbiome-based products, except for probiotics, in the past.You have had a serious allergic reaction to food in the past.You have had a solid organ transplant in the past.You are at risk for getting sick from Cytomegalovirus (CMV) or Epstein Barr virus (EBV).People who live with you, including young children, pregnant women, anyone with a weakened immune system, or anyone 70 years old or older.You have been diagnosed with multiple sclerosis using specific medical guidelines from 2017.You are between 18 and 55 years old.Your Expanded Disability Status Score (EDSS) is between 1.0 and 6.5.You are not currently taking any disease-modifying therapy (DMT), or you are only taking glatiramer acetate or interferon beta.You are currently receiving strong treatment for cancer.You have other serious health conditions involving your lungs, heart, stomach, liver, skin, or urinary system.You have difficulty swallowing that is moderate to severe.You are expected to live for less than six months.You have other known autoimmune diseases at the same time.
Research Study Groups:
This trial has the following groups:- Group 1: Intervention
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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