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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
MS-BIOME Trial Summary
This trial will examine if FMT can improve MS symptoms by using donor stool via colonoscopy and assessing immunological changes over time.
Eligible Conditions
- Relapsing Remitting Multiple Sclerosis
MS-BIOME Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in fecal microbiota
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Subjects who complete the study protocol
Secondary outcome measures
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 moreMS-BIOME 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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Does this investigation permit individuals aged 35 and over to take part?
"This medical trial seeks to include those aged between 18 and 60 years old."
Answered by AI
Has the U.S. Food and Drug Administration approved FMP30 Donor Stool?
"Our team at Power has assessed the safety of FMP30 Donor Stool to be a 1 due to limited evidence regarding its efficacy and security."
Answered by AI
What are the fundamental goals of this experiment?
"The primary goal of this trial is to assess patient results over the course of Baseline Visit, 2 weeks, 4 weeks, 8 weeks and 12 weeks. Additional objectives include measuring serum immunoglobulin levels (IgA, IgG and IgM in mg/dL), observing gadolinium enhancing lesions at baseline and week 12., and counting new T2/FLAIR lesion incidences at both time points as well."
Answered by AI
What criteria are necessary for qualification in this clinical investigation?
"To qualify for this medical study, candidates must be between 18 and 60 years old with a diagnosis of multiple sclerosis. The trial is accepting up to 30 participants."
Answered by AI
Is the opportunity to participate in this experiment still available for prospective participants?
"Per the clinicaltrials.gov database, recruitment for this medical trial has ended. Initially posted on November 16th 2018 and last updated October 7th 2022, although this study is no longer taking in participants there are still 549 other open trials available to join now."
Answered by AI
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