A Trial of Encapsulated Fecal Microbiota for Vancomycin Resistant Enterococcus Decolonization

NCT ID: NCT03063437

Last Updated: 2020-04-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 9 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-08-17
• Study Completion Date: 2019-02-26

Brief 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.

Detailed Description

Note: The Protocol and Statistical Analysis Plan document contains modifications from what is on file at the FDA to reflect redactions and formatting requirements for public posting on ClinicalTrials.gov.

Conditions

Antibiotic Resistant Strain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Active: Encapsulated Fecal Microbiota Preparation

Single dose of oral, encapsulated fecal microbiota preparation (30 capsules per dose) with follow-up at 3 days, 10 days, 28 days, and 6 months.

Group Type: EXPERIMENTAL

Encapsulated fecal microbiota preparation

Intervention Type: BIOLOGICAL

30 capsules

Placebo: Encapsulated Placebo

Single dose of oral, placebo capsule (30 capsules per dose) with follow-up at 3 days, 10 days, and 28 days, and 6 months.

Group Type: PLACEBO_COMPARATOR

Encapsulated placebo

Intervention Type: BIOLOGICAL

30 capsules

Interventions

Encapsulated fecal microbiota preparation

30 capsules

Intervention Type: BIOLOGICAL

Encapsulated placebo

30 capsules

Intervention Type: BIOLOGICAL

Eligibility Criteria

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 for prophylaxis or topical antibiotics.
• Requires continued antibiotic use or anticipates antibiotic use in the upcoming 4 weeks. Does not include antibiotics used for prophylaxis or topical antibiotics.
• Unwilling to withhold probiotics for a minimum of 48 hours prior to providing a screening stool sample.
• Known or suspected toxic megacolon and/or known small bowel ileus.
• Major gastrointestinal surgery (e.g. significant bowel resection) within 3 months before enrollment. This does not include appendectomy or cholecystectomy.
• History of total colectomy or bariatric surgery.
• Admitted to or expected to an intensive care unit for medical reasons (not just boarding). Patients residing in a nursing home, long-term care facility or rehabilitation center may be enrolled.
• Concurrent intensive induction chemotherapy, radiation therapy or biological treatment for active malignancy. Patients on maintenance chemotherapy may be enrolled only after consultation with medical monitor.
• Unable or unwilling to comply with protocol requirements.
• Expected life expectancy < 6 months
• Previous FMT or microbiome-based products at any time excluding this study.
• Patients with a history of severe anaphylactic or anaphylactoid food allergy.
• Solid organ transplant recipients ≤ 90 days post-transplant or on active treatment for rejection.
• Neutropenia (≤500 neutrophils/mL) or other severe immunosuppression. Anti-TNF will be permitted. Patients on monoclonal antibodies to B and T cells. glucocorticoids, antimetabolites (azathioprine, 6-mercaptopurine, methotrexate), calcineurin inhibitors (tacrolimus, cyclosporine) and mycophenolate mofetil may be enrolled only after consultation with the medical monitor.
• If at risk for CMV/EBV associated disease (at investigator's discretion, e.g. immunocompromised), negative IgG testing for cytomegalovirus (CMV) or Epstein Barr Virus (EBV).
• A condition that would jeopardize the safety or rights of the subject, would make it unlikely for the subject to complete the study, or would confound the results of the study.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Wisconsin, Madison

OTHER

Sponsor Role: collaborator

Indiana University

OTHER

Sponsor Role: collaborator

Microbiome Health Research Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Majdi Osman, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Microbiome Health Research Institute d/b/a OpenBiome

Locations

IU Health University Hospital

Indianapolis, Indiana, United States

University of Wisconsin University Hospital

Madison, Wisconsin, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

200-2016-91948

Identifier Type: -

Identifier Source: org_study_id