A Trial of Encapsulated Fecal Microbiota for Vancomycin Resistant Enterococcus Decolonization (NCT03063437) | Clinical Trial Compass
CompletedPhase 2
A Trial of Encapsulated Fecal Microbiota for Vancomycin Resistant Enterococcus Decolonization
United States9 participantsStarted 2017-08-17
Plain-language summary
The objective of this study is to provide preliminary insight into the safety and efficacy of fecal microbiota transplantation (FMT) for the eradication of gastrointestinal carriage of vancomycin-resistant Enterococcus.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Adults 18 years or older at the time of enrollment.
* Able to provide signed and dated informed consent.
* Identified as VRE-positive by a stool culture within last 14 days.
* Women of childbearing potential in sexual relationships with men must use an acceptable method of contraception§ from 30 days prior to enrollment until 4 weeks after completing study treatment.
* Males must agree to avoid impregnation of women during and for four weeks after completing study treatment through use of an acceptable method of contraception\*.
* Includes, but is not limited to, barrier with additional spermicidal foam or jelly, intrauterine device, hormonal contraception (started at least 30 days prior to study enrollment), intercourse with men who underwent vasectomy.
* Includes, but is not limited to, barrier with additional spermicidal foam or jelly and vasectomy.
Exclusion Criteria:
* Female patient who are pregnant, lactating or planning on becoming pregnant during study. Female patients of childbearing potential will undergo a pregnancy test, and be excluded from the study if positive.
* Inability (e.g. dysphagia) to or unwilling to swallow capsules.
* Active antibiotic resistant bacteria (ARB) or gastrointestinal infection at time of enrollment.
* 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 randomization. Does not include antibiotics used …
What they're measuring
1
Percentage of Participants With VRE Decolonization
Timeframe: Day 10 (±3 days) after randomization
2
Percentage of Participants With an Adverse Event (AE); Severe Adverse Event (SAE); and Newly Acquired Transmissible Infectious Diseases Which Are Considered Adverse Events of Special Interest (AESI)