Phase II Trial of Fecal Microbiota Transplant (FMT) for VRE and CRE Patients (NCT03643887) | Clinical Trial Compass
WithdrawnPhase 2
Phase II Trial of Fecal Microbiota Transplant (FMT) for VRE and CRE Patients
Stopped: No funding obtained
0Started 2022-09-01
Plain-language summary
Vancomycin-resistant Enterococcus (VRE) and carbapenem-resistant Enterobacteriaceae (CRE) are multi-drug resistant organisms (MDROs) associated with healthcare settings and are a high priority for containment in public health. Healthcare-associated infections (HAIs) like VRE and CRE lengthen the duration of a hospital stay, increase the cost of hospitalization, and increase mortality. Because colonization precedes infection, prevention or treatment of VRE/CRE colonization is essential. We propose a treatment approach to promote gut decolonization by VRE and CRE without using antibiotics. Participants enrolled in this study will be randomized a one-time dose of either study drug or placebo, will be followed for 6 months, and will submit stool samples for analysis of several outcomes for the trial.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Cognitively intact and willing to provide informed consent
* Willing and able to comply with all study procedures for the duration of the study
* Age 18 years or older
* Two positive stool cultures for CRE or VRE (positive for the same organism on both cultures). The most recent stool culture must be within 14 days of randomization.
* Women of childbearing potential in a sexual relationship with men must use an acceptable method of contraception (including, but not limited to, barrier with additional spermicidal foam or jelly, intrauterine device, hormonal contraception started at least 30 days before enrollment into the study, or intercourse with men who underwent a vasectomy) for 4 weeks following completion of the study treatment.
* Males must agree to avoid impregnation of women during and for 4 weeks following completion of the study treatment through the use of an acceptable method of contraception (including but not limited to, barrier with additional spermicidal foam or jelly or vasectomy).
* Able to take the test capsule successfully with no signs or symptoms of dysphagia.
Exclusion Criteria:
* Admitted to an intensive care unit (ICU) for medical reasons (not just boarding).
Patients residing in a nursing home, long-term care facility or rehabilitation center may be enrolled.
* Patient received antibiotics in the last 48 hours. Patients will be eligible to enroll if antibiotic therapy is discontinued for at minimum 48 hours prior to randomi…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Compare incidence of VRE/CRE decolonization between FMT Capsule double encapsuled (DE) and placebo