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Trial record 14 of 22 for:    capsule | Recruiting Studies | fecal microbiota transplantation

Fecal Microbiota Transplantation (FMT) for Clostridium Difficile (CEFTA)

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ClinicalTrials.gov Identifier: NCT03712722
Recruitment Status : Recruiting
First Posted : October 19, 2018
Last Update Posted : January 11, 2019
Sponsor:
Information provided by (Responsible Party):
Christian Hvas, University of Aarhus

Brief Summary:
Faecal microbiota transplantation (FMT) is used for recurrent Clostridium difficile infection (rCDI) as part of an quality improvement initiative and conducted within the framework of Center for Faecal Microbiota Transplantation at Aarhus University Hospital (CEFTA).

Condition or disease Intervention/treatment
Clostridium Difficile Infection Other: Faecal microbiota transplantation (FMT)

Detailed Description:
Patients are assessed, treated and monitored at Aarhus University Hospital (AUH) as an Integrated part of the project.

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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Fecal Microbiota Transplantation (FMT) for Recurrent Clostridium Difficile Infection - an Observational Cohort Study
Actual Study Start Date : October 1, 2018
Estimated Primary Completion Date : December 31, 2023
Estimated Study Completion Date : December 31, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bowel Movement

Group/Cohort Intervention/treatment
rCDI
Adult patients with recurrect Clostridium difficile infection
Other: Faecal microbiota transplantation (FMT)
FMT delivered by colonoscopy, nasojejunal tube, glycerol-based capsules, or freeze-dried encapsulated donor faeces




Primary Outcome Measures :
  1. Resolution of Clostridium difficile-Associated disease (CDAD) [ Time Frame: 8 weeks ]
    Number of patients with resolution of CDAD, , defined by the absense of diarrhea (3 or fewer bowel movements per day) and formed stools (Bristol 5 or lower) or, in the case of abnormal stool frequency or consistency, a negative Clostridium difficile toxin test week 8


Secondary Outcome Measures :
  1. Clinical effect week 8 [ Time Frame: 8 weeks ]
    Number of patients with clinical effect, defined by absense of diarrhea (3 or fewer bowel movements per day) and formed stools (Bristol 5 or lower)

  2. Negative CD test week 8 [ Time Frame: 8 weeks ]
    Number of patients with negative Clostridium difficile toxin test week 8


Biospecimen Retention:   Samples With DNA
Faecal samples, plasma


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Adult patients with recurrent Clostridium difficile infection
Criteria

Inclusion Criteria:

  • age 18 or higher
  • documented recurrence of Clostridium difficile

Exclusion Criteria:

  • none

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03712722


Contacts
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Contact: Christian L Hvas, MD PhD +4528351839 christian.hvas@auh.rm.dk

Locations
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Denmark
Aarhus University Hospital Recruiting
Aarhus N, Denmark, 8200
Contact: Christian L Hvas, MD PhD    +45 28351839    christian.hvas@auh.rm.dk   
Sponsors and Collaborators
University of Aarhus

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Responsible Party: Christian Hvas, Associate professor, MD PhD, University of Aarhus
ClinicalTrials.gov Identifier: NCT03712722     History of Changes
Other Study ID Numbers: 1-16-02-15-16
First Posted: October 19, 2018    Key Record Dates
Last Update Posted: January 11, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: data access agreement may be made upon request; contact to PI

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Infection
Clostridium Infections
Gram-Positive Bacterial Infections
Bacterial Infections