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Trial record 26 of 89 for:    Recruiting Studies | fecal microbiota transplantation

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03712722
Recruitment Status : Recruiting
First Posted : October 19, 2018
Last Update Posted : March 24, 2020
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
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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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

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 identifier (NCT number): NCT03712722

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Contact: Christian L Hvas, MD PhD +4528351839

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Aarhus University Hospital Recruiting
Aarhus N, Denmark, 8200
Contact: Christian L Hvas, MD PhD    +45 28351839   
Sponsors and Collaborators
University of Aarhus
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Responsible Party: Christian Hvas, Associate professor, MD PhD, University of Aarhus Identifier: NCT03712722    
Other Study ID Numbers: 1-16-02-15-16
First Posted: October 19, 2018    Key Record Dates
Last Update Posted: March 24, 2020
Last Verified: March 2020
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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Clostridium Infections
Enterocolitis, Pseudomembranous
Gram-Positive Bacterial Infections
Bacterial Infections
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases