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FMT of FMP30 for Multiple Sclerosis (MS-BIOME Trial)
Phase 1
Waitlist Available
Research Sponsored by Jeffrey Gelfand
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 1 year
Awards & highlights
No Placebo-Only Group
Summary
This trial will examine if FMT can improve MS symptoms by using donor stool via colonoscopy and assessing immunological changes over time.
Who is the study for?
Adults aged 18-60 with relapsing-remitting multiple sclerosis (MS) who haven't used MS disease modifying therapies recently, or have had a 12-week break from them. Participants must show recent MS activity, be able to walk (with limitations), and test positive for Epstein-Barr Virus. Women of childbearing age need a negative pregnancy test and agree to use contraception. People can't join if they've taken certain medications recently, are pregnant, have progressive MS, active gut conditions, or any other health issues that could interfere with the study.
What is being tested?
This trial is testing whether transplanting stool from a donor (FMT of FMP30) into patients' intestines via colonoscopy can affect their immune system in a way that helps control MS symptoms. The main part lasts for 12 weeks with follow-up for almost a year. There's also an observational group not getting the treatment but being monitored as comparison.
What are the potential side effects?
Potential side effects may include reactions related to the colonoscopy procedure like abdominal pain or discomfort and risks associated with fecal transplants such as infection transmission. Side effects specific to this trial aren't listed but generally relate to gastrointestinal and immune responses.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change in fecal microbiota
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Subjects who complete the study protocol
Secondary study objectives
Incidence of new T2/FLAIR lesions
Induction of T regulatory or Th2 cells and/or reduction of Th1 or Th17 cells
Measurement of Serum Immunoglobulin Levels
+7 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Interventional FMT Treatment ArmExperimental Treatment2 Interventions
After providing written informed consent, subjects will undergo screening and baseline assessments of stool and blood sampling, questionnaires, physical examination, MS rating scales, and MRI. Subjects will then initiate an oral antibiotic regimen for 5 days to precondition the gut for the Fecal Microbiota Transplantation (FMT) of FMP30 donor stool and optimize engraftment of the FMP30 donor stool microbiome. Following standard bowel preparation for colonoscopy, subjects will undergo the FMT procedure by an experienced gastroenterologist. Subjects will return for scheduled assessments and follow-up MRI for 12 weeks, with additional safety and biomarker follow-up for 36 weeks.
The active study time is designed to be short (12 weeks active phase) to minimize time not on other MS disease modifying therapy (DMT). This arm of the study will last for approximately 52 weeks total (4 weeks of screening + 12 weeks active treatment phase + 36 weeks of safety follow up).
Group II: Observational Control ArmActive Control1 Intervention
Subjects, who otherwise satisfy study inclusion criteria based on their MS phenotype, demographics, disease duration and prior use of allowable MS therapies, will be recruited as a comparison observational group to measure stability of stool and serum immunological measures.
After providing written informed consent, subjects will undergo screening and baseline assessments, including collection of blood and stool samples, demographic data collection, concomitant medication review, and an MS Relapse assessment. At week 2, subjects will mail in stool samples with a prepaid air bill and packaging. Weeks 4, 8, and 12 assessments will include concomitant medication review, relapse assessment, and blood and stool collection.
The duration of the study for the observational control arm will last for 12 weeks. All study procedures will be performed at the University of California, San Francisco.
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Who is running the clinical trial?
Jeffrey GelfandLead Sponsor
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You have taken diuretics like furosemide (Lasix) within 1 week before starting the oral antibiotics.You have advanced multiple sclerosis according to specific guidelines.You have a current ongoing investigation for a stomach or intestine problem.You have had cancer in the past, except for certain types of skin cancer that were removed.You have not taken any medication to treat multiple sclerosis (MS) or you stopped taking it at least 12 weeks ago.You are between 18 and 60 years old when you get checked for the study.You have been diagnosed with relapsing-remitting multiple sclerosis (MS) according to specific guidelines.You have shown signs of multiple sclerosis getting worse recently.Your disability score is less than or equal to 6.0 on the Expanded Disability Status Scale (EDSS), or if you have had multiple sclerosis for more than 15 years, your score is 5.5 or less.You need to have evidence of past Epstein-Barr Virus (EBV) infection.You currently have noticeable symptoms from a C. Difficile infection.Your laboratory test results show specific abnormalities.You have a history of inflammatory bowel disease.You have an ongoing infection such as tuberculosis, HIV, hepatitis, syphilis, or another serious infection.You have a weakened immune system.
Research Study Groups:
This trial has the following groups:- Group 1: Interventional FMT Treatment Arm
- Group 2: Observational Control Arm
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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