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Fecal Microbiota Transplant by Oral Capsules With Lactobacilli for Recurrent Clostridium Difficile Infection

Primary Purpose

Clostridium Difficile Infection

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
FMT-c
FMT-c Lactobacillus
Sponsored by
Universidad Autonoma de Nuevo Leon
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Clostridium Difficile Infection

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)Does not accept healthy volunteers

Inclusion Criteria:

  • Older than 18 years With recurrent CDI

Exclusion Criteria:Older than 18 years

-

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Experimental

    Arm Label

    FMT-c

    FMT-c lactobacillus

    Arm Description

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

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

    Outcomes

    Primary Outcome Measures

    decrease in the number of evacuations
    The cure of CDI was measured

    Secondary Outcome Measures

    Full Information

    First Posted
    January 11, 2019
    Last Updated
    March 1, 2019
    Sponsor
    Universidad Autonoma de Nuevo Leon
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03804736
    Brief Title
    Fecal Microbiota Transplant by Oral Capsules With Lactobacilli for Recurrent Clostridium Difficile Infection
    Official Title
    Fecal Microbiota Transplant by Oral Capsules Enriched With Lactobacilli for Recurrent Clostridium Difficile Infection
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2019
    Overall Recruitment Status
    Unknown status
    Study Start Date
    November 1, 2016 (undefined)
    Primary Completion Date
    June 30, 2018 (Actual)
    Study Completion Date
    December 1, 2019 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Universidad Autonoma de Nuevo Leon

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    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
    Detailed Description
    Investigators designed an open, two-arm study to compare to compare fecal microbiota transplant by oral capsules (FMT-c ) versus FMT-c enriched with Lactobacillus for treatment of C. difficile recurrent infection. From each patient, a fecal sample was obtained at days 0, 3, and 7 after treatment. Fecal samples are analyzed by 16 subunit ribosomal ribonucleic acid (16S rRNA) metagenomic sequencing.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Clostridium Difficile Infection

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Participant
    Masking Description
    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)
    Allocation
    Randomized
    Enrollment
    21 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    FMT-c
    Arm Type
    Active Comparator
    Arm Description
    Patients in this arm received FMT-c (15 capsules every 12 h for 2 days)
    Arm Title
    FMT-c lactobacillus
    Arm Type
    Experimental
    Arm Description
    Patients in this arm received FMT-c Lactobacillus (15 capsules every 12 h for 2 days)
    Intervention Type
    Biological
    Intervention Name(s)
    FMT-c
    Intervention Description
    Patients in the FMT-c receive FMT-c (15 capsules every 12 h for 2 days)
    Intervention Type
    Biological
    Intervention Name(s)
    FMT-c Lactobacillus
    Intervention Description
    Patients in the FMT-c Lactobacillus receive FMT-c Lactobacillus (15 capsules every 12 h for 2 days)
    Primary Outcome Measure Information:
    Title
    decrease in the number of evacuations
    Description
    The cure of CDI was measured
    Time Frame
    up to two days

    10. Eligibility

    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Older than 18 years With recurrent CDI Exclusion Criteria:Older than 18 years -

    12. IPD Sharing Statement

    Learn more about this trial

    Fecal Microbiota Transplant by Oral Capsules With Lactobacilli for Recurrent Clostridium Difficile Infection

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