Microbiota or Placebo After Antimicrobial Therapy for Recurrent C. Difficile at Home (MATCH)

NCT03005379 | Terminated Phase 2 Results FDA Drug

• 1 other identifier: 2004
• Study Type: interventional
• Target: 153
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine whether Fecal Microbiota Therapy (FMT) is effective vs. placebo in the prevention of C. difficile infection recurrence.

Conditions

Clostridium Difficile Infection

Keywords

FMT; recurrent c. difficile; infectious disease; intestine; clinical trial; gastrointestinal; prevention; randomized; diarrhea; fecal microbiota therapy

Outcome Measures

Primary Outcomes (1)

• Possible or Definite Recurrent Clostridium Difficile Infection (CDI), or Death

  The primary outcome is recurrent CDI (definite or possible) or death within 56 days of randomization. A possible CDI recurrence is defined as a new onset of more than three loose or watery stools in 24 hours for two consecutive days, not explained by another diagnosis, other clinical symptoms including ileus, toxic megacolon, or colectomy. As part of the protocol procedures, a possible CDI recurrence is adjudicated by the study's adjudication committee. A definite CDI recurrence is defined as a potential CDI recurrence with symptom (more than three loose or watery stools in 24 hours for two consecutive days, not explained by another diagnosis, other clinical symptoms including ileus, toxic megacolon, or colectomy) plus laboratory confirmation of C. difficile from a stool specimen by toxin Enzyme Immunoassays (EIA) test.

  Within 56 days of randomization

Secondary Outcomes (12)

• Recurrent CDI (Definite or Possible) or Death Within 6 Months of Randomization.

  Within 6 months of randomization

• Quality of Life at 56 Day

  56 days from randomization

• Frequency of Possible CDI Recurrences Within 6 Months of Randomization

  Within 6 months of randomization

• Diarrhea That is Negative for C. Difficile by EIA Toxin Test and Polymerase Chain Reaction (PCR)

  Within 56 days of randomization

• Occurrence of Abdominal Pain Among All Possible CDI Recurrences.

  Within 6 months of randomization

Study Arms (2)

1

ACTIVE COMPARATOR

Fecal Microbiota Therapy (FMT)

Drug: Fecal Microbiota Therapy (FMT)

2

PLACEBO COMPARATOR

Placebo

Drug: Placebo

Interventions

Fecal Microbiota Therapy (FMT) DRUG

Oral capsule-delivered FMT

1

Placebo DRUG

Oral capsule-delivered placebo

2

Eligibility Criteria

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

You may qualify if:

• One or more episodes recurrent CDI (defined as \> 3 loose/watery stools/24h for 2 consecutive days with CDI treatment, and not explained by another diagnosis plus laboratory confirmation of C. difficile; or ileus, or toxic megacolon plus laboratory confirmation of C. difficile, occurring within 90 days of a prior CDI episode with similar symptoms and laboratory confirmation)
• Resolution or improvement of symptoms from most recent CDI episode, defined as no longer meeting the clinical definition for CDI for a 48 hour period during treatment, including not meeting the definition again after an initial improvement
• Within the enrollment window: 2 days after completion of antimicrobial therapy for CDI (to allow for a washout period) to 14 days after completion of therapy or 30 days after the onset of CDI whichever is later.
• Age 18 years
• Enrolled in a Veterans Health Administration (VHA) facility
• Able and willing to provide informed consent

You may not qualify if:

• Unlikely to swallow capsules
• Pregnancy, planning to be pregnant, or breastfeeding
• Receipt of cytotoxic chemotherapy, intravenous or subcutaneous immune globulin, or confirmed neutropenia (absolute neutrophil count of \< 1,000 cells/ L) within the past 3 months
• Inflammatory bowel disease or other chronic diarrheal disease/fecal incontinence predating CDI
• Ongoing antibiotic use other than those for the current episode of CDI
• Prior FMT
• Life expectancy of \< 8 weeks
• Anaphylactic food allergy
• Active enrollment in another research study on antibiotics, probiotics, or FMT without investigators approval
• Presence of an ileostomy or colostomy
• HIV with Clusters of Differentiation 4 (CD4) cell count \< 200 cells/µL in prior 3 months
• Decompensated cirrhosis
• Bone marrow/peripheral blood stem cell transplant in the past year
• Unlikely to follow study protocol

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (1)

Minneapolis VA Health Care System, Minneapolis, MN

Minneapolis, Minnesota, 55417-2309, United States

Location

Related Publications (2)

• Drekonja DM, Shaukat A, Zhang JH, Reinink AR, Nugent S, Dominitz JA, Davis-Karim A, Gerding DN, Kyriakides TC. Microbiota or placebo after antimicrobial therapy for recurrent Clostridioides difficile at home: A clinical trial with novel home-based enrollment. Clin Trials. 2021 Oct;18(5):622-629. doi: 10.1177/17407745211021198. Epub 2021 Jun 22.

  PMID: 34154439 RESULT

• Drekonja DM, Shaukat A, Huang Y, Zhang JH, Reinink AR, Nugent S, Dominitz JA, Davis-Karim A, Gerding DN, Kyriakides TC. A Randomized Controlled Trial of Efficacy and Safety of Fecal Microbiota Transplant for Preventing Recurrent Clostridioides difficile Infection. Clin Infect Dis. 2025 Feb 5;80(1):52-60. doi: 10.1093/cid/ciae467.

  PMID: 39271107 DERIVED

MeSH Terms

Conditions

Clostridium Infections; Communicable Diseases; Diarrhea

Condition Hierarchy (Ancestors)

Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms, Digestive; Signs and Symptoms

Results Point of Contact

• Title: Yuan Huang, Ph.D., Biostatistician
• Organization: VA Cooperative Studies Program

yuanhuang1@va.gov

2039325711

Study Officials

• Dimitri M Drekonja, MD

  Minneapolis VA Health Care System, Minneapolis, MN

  STUDY CHAIR

• Aasma Shaukat, MD MPH

  Minneapolis VA Health Care System, Minneapolis, MN

  STUDY CHAIR

Publication Agreements

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

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: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 14, 2016
• First Posted: December 29, 2016
• Study Start: November 15, 2018
• Primary Completion: August 30, 2022
• Study Completion: January 31, 2023
• Last Updated: April 11, 2024
• Results First Posted: October 11, 2023

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF

Locations

US (1)