A Trial of Encapsulated Fecal Microbiota for Vancomycin Resistant Enterococcus Decolonization

NCT03063437 | Completed Phase 2 Results DMC FDA Drug

• 1 other identifier: 200-2016-91948
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 2

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.

Conditions

Antibiotic Resistant Strain

Keywords

vancomycin resistant enterococcus; VRE; decolonization; VRE colonization; fecal microbiota transplantation; FMT; FMT capsule; capsule; antimicrobial resistance; antibiotic resistance; MDRO; multidrug-resistant organism; OpenBiome

Outcome Measures

Primary Outcomes (2)

• Percentage of Participants With VRE Decolonization

  VRE decolonization is defined by absence of VRE on stool culture using standard clinical laboratory techniques at Day 10 (± 3 days) after randomization.

  Day 10 (±3 days) after randomization

• 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)

  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) through Day 10 (± 3 days) after randomization.

  Day 10 (±3 days) after randomization

Secondary Outcomes (9)

• Percentage of Participants With VRE Infection

  Week 4 (±5 days) after randomization

• Percentage of Participants With ARB Colonization on Day 10 Following Fecal Microbiota Transplantation (FMT)

  Day 10 (± 3 days) after randomization

• Percentage of Participants With ARB Infection 4 Weeks Following FMT

  Week 4 (±5 days) after randomization

• Number of Days Between FMT and VRE Colonization and Infection Occurs

  Up to 6 months after randomization

• VRE Decolonization Among Immunocompromised Patients

  Day 10 (± 3 days) after randomization

Other Outcomes (2)

• Microbiome Disruption

  Day 3, day 10, week 4 after randomization.

• Engraftment Dynamics

  6 months following FMT

Study Arms (2)

Active: Encapsulated Fecal Microbiota Preparation

EXPERIMENTAL

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.

Biological: Encapsulated fecal microbiota preparation

Placebo: Encapsulated Placebo

PLACEBO COMPARATOR

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

Biological: Encapsulated placebo

Interventions

Encapsulated fecal microbiota preparation BIOLOGICAL

30 capsules

Active: Encapsulated Fecal Microbiota Preparation

Encapsulated placebo BIOLOGICAL

30 capsules

Placebo: Encapsulated Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Microbiome Health Research Institute: lead
• University of Wisconsin, Madison: collaborator
• Indiana University: collaborator

Study Sites (2)

IU Health University Hospital

Indianapolis, Indiana, 46202, United States

Location

University of Wisconsin University Hospital

Madison, Wisconsin, 53792, United States

Location

Results Point of Contact

• Title: Majdi Osman, MD, MPH
• Organization: Microbiome Health Research Institute

majdi@openbiome.org

6175752201

Study Officials

• Majdi Osman, MD, MPH

  Microbiome Health Research Institute d/b/a OpenBiome

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 17, 2017
• First Posted: February 24, 2017
• Study Start: August 17, 2017
• Primary Completion: September 19, 2018
• Study Completion: February 26, 2019
• Last Updated: April 13, 2020
• Results First Posted: February 5, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)