Efficacy and Safety of Fecal Microbiota Transplantation for Severe Clostridium Difficile Associated Colitis

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: NCT01959048
Recruitment Status : Recruiting
First Posted : October 9, 2013
Last Update Posted : February 23, 2017
Information provided by (Responsible Party):
STRAHILEVITZ JACOB, Hadassah Medical Organization

Brief Summary:

Clostridium difficile has become one of the leading causes of hospital acquired infections, and is associated with increased mortality. Patients with C. difficile associated disease (CDAD) possess deficiencies in 'normal' fecal microbial composition, most likely as a result of earlier antibiotic usage. The current standard of care treatment for severe C. difficile, which consists of antibiotics, does not restore the microbiota. Restoration of the normal colonic microbiota by fecal microbiota transplantation (FMT) may enable reversion colonic microbial population to a more 'normal'state and lead to cure.

A few patients develop severe CDAD which may be complicated by adynamic ileus, or toxic megacolon. The management in this context is based on limited data, and for some the only available option is sub-total colectomy.

Although FMT is by no means a new therapeutic modality, there is limited information on its use for the treatment of acute CDAD, including severe CDAD. Because of the high morbidity and mortality associated with treatment of patients with severe CDAD, and because the evidence supporting the current recommendations is weak and based upon the demonstration that FMT is an effective strategy to re-establish a balanced intestinal microbiota with resultant cure of recurrent CDAD, we propose to study the efficacy and safety of FMT for severe CDAD.

Patients with severe CDAD can be divided into two operational groups; those that have diarrhea and those that suffer from adynamic ileus. We propose to apply FMT through colonoscopy for all patients because current data suggest that the overall success rate of FMT for recurrent CDAD with lower gastrointestinal tract FMT was higher than FMT through the upper gastrointestinal tract. In addition, for patients with adynamic ileus and toxic megacolon (i.e., the population with the highest CDAD-associated morbidity and mortality), intra-colonic FMT administration is the preferred alternative.

Condition or disease Intervention/treatment Phase
Clostridium Difficile Drug: fecal microbiota transplantation Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Efficacy and Safety of Fecal Microbiota Transplantation for Severe Clostridium Difficile Associated Colitis
Study Start Date : November 2013
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : December 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bowel Movement
U.S. FDA Resources

Arm Intervention/treatment
Experimental: fecal microbiota transplant
fecal microbiota transplantation
Drug: fecal microbiota transplantation

Primary Outcome Measures :
  1. Resolution of severe CDAD [ Time Frame: 2 weeks ]
    decrease of diarrhea, time to decrease in elevated white blood cell count

  2. Recurrence of CDAD [ Time Frame: 2 weeks ]

Secondary Outcome Measures :
  1. all cause mortality [ Time Frame: 30 days ]
  2. Need for colectomy [ Time Frame: 30 days ]
  3. Morbidity [ Time Frame: 1 weeks ]
    immediate colonoscopy-related complications, secondary infection

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Both genders are eligible for study
  2. Age 18 years and older
  3. Able to provide written, informed consent
  4. Confirmed diagnosis of severe CDAD as defined above

Exclusion Criteria:

(If any of the following apply, the subject MUST NOT enter the study):

  1. Pregnant or lactating women
  2. Need for prolonged antibiotics for other cause
  3. Other known etiology for diarrhea, or clinical infection with other known enteric pathogens
  4. Active, chronic conditions such as: Inflammatory bowel disease, Crohn's disease, Short bowel syndrome, Ulcerative or ischemic colitis
  5. Laxatives or motility-altering drugs within 12 hours of enrolment
  6. Clinically unstable. Hemodynamic instability defined as hypotension (mean arterial pressure < 60) not responsive to fluids.
  7. Any condition that, in the opinion of the investigator, would preclude safe participation in the trial or compromise the quality of the data obtained.
  8. Immune suppression, HIV, hematological or solid malignancy (chemotherapy in the past 3 months).
  9. Prior colon surgery

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): NCT01959048

Hadassah Medical Center Recruiting
Jerusalem, Israel, 91120
Contact: Jacob Strahilevitz, MD    972-2-6776543   
Principal Investigator: Jacob Strahilevitz, MD         
Sponsors and Collaborators
Hadassah Medical Organization
Principal Investigator: Jacob Strahilevitz, MD Hadassah Medical Organization

Responsible Party: STRAHILEVITZ JACOB, Senior physician, Hadassah Medical Organization Identifier: NCT01959048     History of Changes
Other Study ID Numbers: HMO-0676-12
First Posted: October 9, 2013    Key Record Dates
Last Update Posted: February 23, 2017
Last Verified: February 2017

Keywords provided by STRAHILEVITZ JACOB, Hadassah Medical Organization:
Clostridium difficile associated disease
fecal microbiota transplantation

Additional relevant MeSH terms:
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
Intestinal Diseases