Your session is about to expire
← Back to Search
Other
Microbiota Capsules vs Fecal Transplants for C. Difficile Infection
Phase 1
Recruiting
Led By Ari Grinspan, MD
Research Sponsored by Icahn School of Medicine at Mount Sinai
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 24 weeks
Awards & highlights
Study Summary
This trial tests 4 treatments for MTC or FMT to find which works best.
Who is the study for?
This trial is for adults over 18 who've had at least two episodes of a specific infection called recurrent Clostridioides Difficile Infection (RCDI) in the last six months. Participants must have had diarrhea as part of this condition and tested positive for the infection recently. They should have responded to standard antibiotics before joining.Check my eligibility
What is being tested?
The study is comparing four different treatments using either MTC 01 or Fecal Microbiota Transplantation (FMT). These are therapies aimed at restoring healthy bacteria in the gut to combat RCDI.See study design
What are the potential side effects?
While not specified here, side effects for these types of treatments can include digestive discomfort, bloating, cramps, nausea or fever. Serious side effects might involve infections if unhealthy microbes are transferred.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 24 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 24 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Number of participants with treatment-related adverse events as assessed by CTCAE 5.0
Number of treatment-related serious adverse events (SAE) as assessed by NIH grading
Secondary outcome measures
Percent of patients who develop Clostridioides difficile (C difficile)
Trial Design
4Treatment groups
Experimental Treatment
Active Control
Group I: Low Dose MTC 01Experimental Treatment1 Intervention
Low Dose MTC 01 is 10 x 10 CFU slurry to be administered via colonoscopy
Group II: High Dose MTC 01Experimental Treatment1 Intervention
High dose MTC 01 is 10 x 11 CFU slurry to be administered via colonoscopy
Group III: High Dose Fecal Microbiota Transplantation (FMT)Experimental Treatment1 Intervention
Low dose FMT is 10 x 10 CFU slurry to be administered via colonoscopy
Group IV: Low dose Fecal Microbiota Transplantation (FMT)Active Control1 Intervention
High dose FMT is 10 x 11 CFU slurry to be administered via colonoscopy
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Fecal Microbiota Transplantation (FMT)
2016
Completed Phase 1
~170
Find a Location
Who is running the clinical trial?
Icahn School of Medicine at Mount SinaiLead Sponsor
862 Previous Clinical Trials
525,566 Total Patients Enrolled
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH
2,359 Previous Clinical Trials
4,314,532 Total Patients Enrolled
Ari Grinspan, MDPrincipal InvestigatorIcahn School of Medicine at Mount Sinai
1 Previous Clinical Trials
4 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have had a fecal microbiota transplant in the last year.I am currently hospitalized but can be an outpatient for my colonoscopy.I do not have a severe, swollen colon or blockage in my intestines.I have an active stomach or intestinal infection not caused by C. diff.I haven't had leukemia, stem cell transplant, or intense chemotherapy in the last 2 months.I am not taking medication that affects how my gut moves.I have had more than one Clostridium difficile infection episode.I have completed a standard antibiotic treatment for my recent CDI episode.I have had surgery to remove my colon and rectum.I am scheduled for surgery within the next 30 days.I need to keep taking antibiotics that are not for C. diff infection.I am not pregnant, breastfeeding, nor planning to become pregnant during the study.I have not had major stomach or intestine surgery in the last 3 months.I cannot or do not want to have a colonoscopy.My symptoms of CDI started less than 60 days ago.I have had severe diarrhea for two or more days in a row.I had 3 or fewer loose stools per day for 2+ days on standard antibiotics.I have had Clostridium difficile infection (CDI) twice in the last 6 months.I have a history of diarrhea due to inflammatory bowel disease.My doctor thinks it's unsafe for me to join due to my health or medications.I am unable to understand and give consent for treatment.I am 18 years old or older.
Research Study Groups:
This trial has the following groups:- Group 1: High Dose MTC 01
- Group 2: Low Dose MTC 01
- Group 3: Low dose Fecal Microbiota Transplantation (FMT)
- Group 4: High Dose Fecal Microbiota Transplantation (FMT)
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.
Is the research team accepting new participants for this experiment?
"Contrary to what one might expect, clinicaltrials.gov reveals that this study is not currently enlisting any new participants. The trial was initially posted on June 23rd 2023 and the last update came a few weeks later in early July of the same year; however, there are still 773 different medical studies actively recruiting patients at present."
Answered by AI
Is High Dose MTC 01 proven to be a safe medical regimen?
"High Dose MTC 01 was assessed to be of low safety, with a score of 1 given its status as an early phase trial and the lack of evidence for both efficacy and protection."
Answered by AI
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger