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Oral FMT for Multiple Sclerosis
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.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
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- 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.
- Group 1: Intervention
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- 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
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."
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."
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."
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."
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