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

NCT01959048 | Terminated Results

• 1 other identifier: HMO-0676-12
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

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.

Conditions

Clostridium Difficile

Keywords

Clostridium difficile associated disease; fecal microbiota transplantation

Outcome Measures

Primary Outcomes (2)

• Number of Participants With Resolution of Severe CDAD

  Resolution of diarrhea, time to decrease in elevated WBC count

  2 weeks

• Number of Participants With Relapse of CDAD

  Number of Participants with evidence of relapse of C. diff. associated diarrhea

  2 weeks

Secondary Outcomes (3)

• All Cause Mortality

  30 days

• Need for Colectomy

  30 days

• Morbidity

  1 weeks

Study Arms (1)

fecal microbiota transplant

EXPERIMENTAL

fecal microbiota transplantation

Drug: fecal microbiota transplantation

Interventions

fecal microbiota transplantation DRUG

fecal microbiota transplant

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Hadassah Medical Organization: lead

Study Sites (1)

Hadassah Medical Center

Jerusalem, 91120, Israel

Location

MeSH Terms

Interventions

Fecal Microbiota Transplantation

Intervention Hierarchy (Ancestors)

Biological Therapy; Therapeutics

Results Point of Contact

• Title: Jacob Strahilevitz
• Organization: Hadassah-Hebrew University

jstrahilevitz@hadassah.org.il

972508946353

Study Officials

• Jacob Strahilevitz, MD

  Hadassah Medical Organization

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior physician

Study Record Dates

• First Submitted: October 7, 2013
• First Posted: October 9, 2013
• Study Start: April 1, 2014
• Primary Completion: January 1, 2016
• Study Completion: January 1, 2016
• Last Updated: August 21, 2019
• Results First Posted: March 19, 2019

Record last verified: 2019-08

Locations

IL (1)