Fecal Microbiota Transplantation (FMT) in Recipients After Allogeneic Hematopoietic Cell Transplantation (HCT)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03720392|
Recruitment Status : Active, not recruiting
First Posted : October 25, 2018
Last Update Posted : November 26, 2019
|Condition or disease||Intervention/treatment||Phase|
|Allogeneic Hematopoietic Cell Transplantation (HCT)||Drug: FMT Drug: Placebo||Phase 2|
This research study is a Phase II clinical trial. Phase II clinical trials test the safety and effectiveness of an investigational intervention to learn whether the intervention works in treating a specific disease. "Investigational" means that the intervention is being studied.
The FDA (the U.S. Food and Drug Administration) has not approved FMT for this use.
After HCT, the body's microbiome (the natural existence of various bacteria and organisms) in the intestinal tract may be affected, in that the number and types of good bacteria is reduced (also called a reduction in microbial flora diversity). Studies have shown that the number and types of good bacteria in the gut can impact whether or not a person develop a disease called graft-versus-host disease (GVHD). GVHD occurs when donated bone marrow cells attack the body with an immune response. Researchers believe that more microbial flora diversity in the gut is linked to a lower risk of developing GVHD.
FMT is a process utilizing microbial components which are the good, healthy bacteria that would otherwise naturally occur in the body. Since the participant may have decreased microbial flora diversity after HCT, these microbial components are taken from a 3rd party donor. They are extracted from fecal matter (stool) and put into a capsule which the participant then ingest.
Researchers believe that FMT administration may play a role in restoring higher microbial flora diversity in the gut. Therefore, FMT administration may play a role in decreasing the likelihood of developing GVHD.
In this research study, the investigators are...
- Examining the microbial flora diversity of your gut after FMT administration
- Looking for incidence rate of GVHD and other post-HCT complications
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||48 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||A Phase 2 Study of Fecal Microbiota Transplantation (FMT) in Recipients After Allogeneic Hematopoietic Cell Transplantation (HCT)|
|Actual Study Start Date :||January 15, 2019|
|Estimated Primary Completion Date :||November 30, 2020|
|Estimated Study Completion Date :||November 30, 2021|
Experimental: FMT Capsules
FMT is a process utilizing microbial components which are the good, healthy bacteria that would otherwise naturally occur in the body.
Placebo Comparator: Placebo Capsules
a harmless pill, medicine, or procedure prescribed more for the psychological benefit to the patient than for any physiological effect.
- The proportion of patients who achieve gut microbiome diversity at one month following the final post-HCT FMT [ Time Frame: 1 Month ]Gut microbiome diversity will be assessed using urinary 3-indoxyl sulfate (3-IS) levels, with 35 umol/mmol creatinine as the cutoff (≥ 35: diverse; < 35: not diverse).
- Cumulative Incidence of Acute Graft-Versus-Host-Disease (GvHD) [ Time Frame: 6 months ]The cumulative incidence of overall grades II-IV and grades III-IV acute GVHD will be assessed through six months after last dose of FMT or placebo. Acute GVHD will be assessed using the Mount Sinai Acute GVHD International Consortium (MAGIC) criteria.
- Cumulative Incidence of non-relapse-mortality [ Time Frame: 6 Months,12 Months ]Non-relapse mortality (NRM) is defined as the time from first dose of FMT or placebo to death without relapse or progression or underlying disease.
- Cumulative incidence of infection at 100 days [ Time Frame: 100 Days ]
- Progression Free Survival [ Time Frame: 6 Months, 12 Months ]Progression-Free Survival (PFS) is defined as the time from first dose of FMT or placebo to the earlier of underlying disease progression or death due to any cause.
- Overall Survival [ Time Frame: 6 Months, 12 Months ]Overall survival is measured as the amount of time from the first dose of Fecal Microbiota Transplantation (FMT) or placebo to death due to any cause.
- Graft Versus Host Disease(GVHD)/ Relapse Free Survival (GRFS) [ Time Frame: 12 Months ]GVHD-Free/Relapse-Free Survival (GRFS) is defined as the time from first dose of FMT or placebo to the earlier of diagnosis of GVHD or disease progression or relapse.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03720392
|United States, Massachusetts|
|Massachusetts General Hospital Cancer Center|
|Boston, Massachusetts, United States, 02214|
|Principal Investigator:||zachariah DeFilipp, MD||Massachusetts General Hospital|