NCT03804736

Brief Summary

Investigators designed an open, two-arm study to compare fecal microbiota transplant by oral capsules (FMT-c ) versus FMT-c enriched with Lactobacillus for treatment of C. difficile recurrent infection

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
21

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2016

Typical duration for not_applicable

Status
unknown

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

November 1, 2016

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2018

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

January 11, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 15, 2019

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2019

Completed
Last Updated

March 5, 2019

Status Verified

March 1, 2019

Enrollment Period

1.7 years

First QC Date

January 11, 2019

Last Update Submit

March 1, 2019

Conditions

Clostridium Difficile Infection

Outcome Measures

Primary Outcomes (1)

  • decrease in the number of evacuations

    The cure of CDI was measured

    up to two days

Study Arms (2)

FMT-c

ACTIVE COMPARATOR

Patients in this arm received FMT-c (15 capsules every 12 h for 2 days)

Biological: FMT-c

FMT-c lactobacillus

EXPERIMENTAL

Patients in this arm received FMT-c Lactobacillus (15 capsules every 12 h for 2 days)

Biological: FMT-c Lactobacillus

Interventions

FMT-cBIOLOGICAL

Patients in the FMT-c receive FMT-c (15 capsules every 12 h for 2 days)

FMT-c
FMT-c LactobacillusBIOLOGICAL

Patients in the FMT-c Lactobacillus receive FMT-c Lactobacillus (15 capsules every 12 h for 2 days)

FMT-c lactobacillus

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Older than 18 years With recurrent CDI

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Clostridium Infections

Condition Hierarchy (Ancestors)

Gram-Positive Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfections

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 FMT-c (15 capsules every 12 h by 2 days) or a FMT-c and Lactobacillus (15 capsules every 12 h by 2 days)
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 11, 2019

First Posted

January 15, 2019

Study Start

November 1, 2016

Primary Completion

June 30, 2018

Study Completion

December 1, 2019

Last Updated

March 5, 2019

Record last verified: 2019-03