Phase II Trial of Fecal Microbiota Transplant (FMT) for VRE and CRE Patients

NCT03643887 | Withdrawn Phase 2 DMC

• 1 other identifier: W81XWH18PRMPCTA
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Clostridium Difficile Infection

Outcome Measures

Primary Outcomes (1)

• Compare incidence of VRE/CRE decolonization between FMT Capsule double encapsuled (DE) and placebo

  VRE/CRE decolonization is defined by absence of VRE/CRE on stool culture using standard laboratory techniques.

  6 months

Secondary Outcomes (5)

• VRE/CRE infection at Day 3, Day 10, and Week 4 following randomization.

  1 month

• Microbial engraftment assessed by microbial disruption index (MDI) at Day 3, Day 10, and Week 4 following randomization

  1 month

• Antibiotic resistant bacteria (ARB) decolonization at Day 10 after randomization.

  10 days

• Antibiotic resistant bacteria (ARB) infection at Day 3, Day 10, Week 4 after randomization, and time to infection if ARB infection occurs

  1 month

• Adverse events/serious adverse events through Day 10, Week 4, and Month 6 following randomization.

  6 months

Study Arms (2)

FMT Capsule DE

EXPERIMENTAL

FMT Capsule DE

Drug: FMT Capsule DE

Placebo Oral Capsule

PLACEBO COMPARATOR

Placebo Capsule

Drug: Placebo oral capsule

Interventions

FMT Capsule DE DRUG

30 capsule one-time oral dose

FMT Capsule DE

Placebo oral capsule DRUG

30 capsule one-time oral dose

Also known as: Placebo

Placebo Oral Capsule

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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 randomization. Does not include antibiotics used for prophylaxis or topical antibiotics.
• Requires continued antibiotic use or anticipates antibiotic use in the upcoming 4 weeks.
• Unwilling to withhold probiotics for a minimum of 48 hours prior to providing a screening stool sample.
• Previous FMT or microbiome-based products in the last 90 days.
• Active antibiotic-resistant bacteria (ARB) or gastrointestinal infection at time of enrollment.
• Any other gastrointestinal illness including diarrhea.
• Known or suspected toxic megacolon and or known small bowel ileus.
• Bowel obstruction or other gut motility issues as noted by the patient or in the electronic medical record.
• Major gastrointestinal surgery (e.g. significant bowel resection) within 3 months before enrollment not including appendectomy or cholecystectomy.
• History of total colectomy or bariatric surgery.
• Concurrent intensive induction chemotherapy, radiation therapy, or biologic treatment for an active malignancy. Patients on maintenance chemotherapy may be enrolled after consultation with the medical monitor.
• Patients with severe anaphylactic or anaphylactoid food allergy.
• Solid organ transplant recipients ≤90 days post-transplant or on active treatment for rejection.

Sponsors & Collaborators

• University of Wisconsin, Madison: lead

MeSH Terms

Conditions

Clostridium Infections

Interventions

Fecal Microbiota Transplantation

Condition Hierarchy (Ancestors)

Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Intervention Hierarchy (Ancestors)

Biological Therapy; Therapeutics

Study Officials

• Nasia Safdar, MD PhD

  Infectious Disease, School of Medicine & Public Health, University of Wisconsin-Madison

  PRINCIPAL INVESTIGATOR

Study Design

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

Model Details: Double-blind, randomized, placebo controlled trial

Study Record Dates

• First Submitted: August 21, 2018
• First Posted: August 23, 2018
• Study Start: September 1, 2022
• Primary Completion: September 1, 2022
• Study Completion: June 30, 2025
• Last Updated: February 23, 2021

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will not share