NCT03107169

Brief Summary

Investigators designed an open, two-arm study to compare oral vancomycin with a fecal microbiota transplant (FMT) from a fecal donor-unrelated donor mix (FURM) as treatments for the first Clostridium difficile infection (CDI) episode among hospitalized patients.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2015

Shorter than P25 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2015

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2015

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

March 21, 2017

Completed
21 days until next milestone

First Posted

Study publicly available on registry

April 11, 2017

Completed
Last Updated

April 18, 2017

Status Verified

April 1, 2017

Enrollment Period

8 months

First QC Date

March 21, 2017

Last Update Submit

April 15, 2017

Conditions

Clostridium Difficile Infection

Outcome Measures

Primary Outcomes (1)

  • Decrease in number of evacuations

    The cure of CDI was measured

    up to a 2 days

Study Arms (2)

Vancomycin

ACTIVE COMPARATOR

Patients in this arm received vancomycin 250mg every 6 hrs for 10-14 days

Drug: Vancomycin

FMT-FURM

EXPERIMENTAL

Patients in this arm receive FMT-FURM

Other: FMT

Interventions

FMTOTHER

Patients in the FMT group received FMT-FURM

Also known as: fecal microbiota transplant
FMT-FURM
VancomycinDRUG

Patients in the vancomycin group received oral vancomycin (250 mg every 6 h for 10-14 days)

Also known as: Glycopeptide
Vancomycin

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Clinical diagnosis of CDI (first episode)
  • Older than 18 years old

You may not qualify if:

  • Patients younger than 18 years old

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Clostridium Infections

Interventions

Fecal Microbiota TransplantationVancomycinGlycopeptides

Condition Hierarchy (Ancestors)

Gram-Positive Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfections

Intervention Hierarchy (Ancestors)

Biological TherapyTherapeuticsGlycoconjugatesCarbohydratesPeptidesAmino Acids, Peptides, and Proteins

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Patients were randomized by a closed envelope method in a 1: 1 ratio to either oral vancomycin (every 6 h for 10-14 days) or a FMT-FURM
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr.

Study Record Dates

First Submitted

March 21, 2017

First Posted

April 11, 2017

Study Start

February 1, 2015

Primary Completion

September 30, 2015

Study Completion

September 30, 2015

Last Updated

April 18, 2017

Record last verified: 2017-04

Data Sharing

IPD Sharing
Will not share