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Fecal Microbiota Therapy for Recurrent Clostridium Difficile Colitis

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ClinicalTrials.gov Identifier: NCT01973465
Recruitment Status : Unknown
Verified October 2013 by John Farrell, OSF Healthcare System.
Recruitment status was:  Recruiting
First Posted : October 31, 2013
Last Update Posted : October 31, 2013
Sponsor:
Information provided by (Responsible Party):
John Farrell, OSF Healthcare System

Brief Summary:

This study was developed in response to the July, 2013 FDA draft guidance regarding FMT for CDI. The weight of the evidence in the literature suggests that FMT is the most effective treatment for ambulatory outpatients affected by recurrent CDI who fail conventional therapy.

The anticipated benefits to research patients enrolled in this study include resolution of chronic diarrhea, return of bowel habits and nutritional status to normal, and resolution of chronic recurrent CDI.

FMT involves the endoscopic instillation of freshly obtained stool with millions of live bacteria into the recipient's colon by endoscopic lavage. With any endoscopic procedure, there is a risk of perforated viscous. This is very rare, but the risk is increased with severe CDI. The risk of acquisition of communicable enteric or blood borne pathogen appears to be negligible.


Condition or disease Intervention/treatment Phase
Clostridium Difficile Biological: Stool Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Fecal Microbiota Therapy for Recurrent Clostridium Difficile Colitis
Study Start Date : September 2013
Estimated Primary Completion Date : September 2014
Estimated Study Completion Date : September 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bowel Movement

Arm Intervention/treatment
Experimental: Fecal Microbiota Therapy Biological: Stool
Implanting fecal matter via colonscope




Primary Outcome Measures :
  1. Weight and Number of bowel movements/day [ Time Frame: 30 and 90 days ]
    In the present study we will record each subjects weight and number of bowel movements/day prior to FMT and following FMT at 30 and 90 days.


Secondary Outcome Measures :
  1. Evaluate the most appropriate patient population for FMT [ Time Frame: 30 and 90 days ]
    Our study will include ambulatory outpatients as well as hospitalized, debillitated patients. FMT has demonstrated effectiveness (both systematic reviews and RCT) for treatment of recurrent Clostridium difficile infection in ambulatory outpatient populations. A secondary outcome of our study is to evaluate stratify our patient population and examine FMT success rates for out two primary outcome measures in outpatients vs. inpatients.

  2. Determine the overall success of FMT [ Time Frame: 30 and 90 days ]
    An additional secondary outcome measure will be to examine the percent of patients who undergo 2nd or third FMT. and the success rate (in terms of primary outcome measures) for each subsequent FMT.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Patients > 18 years of age
  2. The patient has been treated with appropriate antimicrobial therapy for CDI.
  3. The patient has documented relapse/recurrence of infection as demonstrated by positive stool culture, or cytotoxin assay, or PCR toxin assay.
  4. Since this study does not involve treatments that have potential teratogenicity, and in general avoidance of antimicrobial treatment during pregnancy is advised (metronidazole is pregnancy category C), women of child-bearing age may be included in the study.

Exclusion Criteria:

- Patients will be excluded from study participation if one of the following categories of exclusion criteria applies:

  1. Patient is < 18 years of age
  2. Patient has an absolute neutrophil count < 750 cells/mm3.

Stool donors must:

  1. be > 18 years of age
  2. Complete a screening questionnaire:

    a. One-time donors: Table 1 b. Designated, pre-screened donors: Table 2

  3. Be tested for communicable blood-borne and enteric pathogens:

    1. One-time donors: Table 3
    2. Designated, pre-screened donors: Table 4

Table 1: Questionnaire to screen one-time stool donors prior to FMT.

You have been identified as a potential stool donor by __________________ , your (spouse/ son/ daughter/ mother/ father/ life partner), who has been referred for fecal transplantation. Prior to performing the transplantation procedure, the OSF/Saint Francis Medical Center Infection Control Committee requires completion of a screening questionnaire by all potential stool donors:

Your name: ___________________________________________ Date: ___/___/ 2013

Your relationship to the patient: ___________________________ YES / NO

  1. Have you ever been diagnosed with Clostridium difficile colitis?
  2. Are you currently taking antibiotic medications?
  3. Have you been prescribed antibiotics in the past six weeks?

IF the potential stool donor answers YES to questions 1, 2, or 3 - please STOP.

Do you have a history of any of the following: (Please Circle)

Hepatitis A YES / NO Hemophilia YES / NO Hemodialysis treatment YES / NO Rejected or refused blood donation YES / NO HIV/AIDS YES / NO Hepatitis B YES / NO Hepatitis C YES / NO Use of intravenous drugs or medications YES / NO Incarceration YES / NO Abnormal blood tests of liver enzymes YES / NO Accepting money or drugs in exchange for sex YES / NO Receipt of a blood transfusion between 1977 - 1992 YES / NO Infectious gastroenteritis or diarrhea YES / NO

Did you answer YES to any of the above? YES / NO

Table 2: Questionnaire to screen designated stool donors prior to each FMT.

You have been identified as a potential stool donor for a patient who has been referred to Saint Francis Medical Center for fecal transplantation. Prior to performing the transplantation procedure, the OSF/Saint Francis Medical Center Infection Control Committee requires completion of a screening questionnaire by all potential stool donors:

Your name: ___________________________________________ Date: ___/___/ 2013

Your relationship to the patient: ___________________________ YES / NO

1. Have you ever been diagnosed with Clostridium difficile colitis?

4. Are you currently taking antibiotic medications?

5. Have you been prescribed antibiotics in the past six weeks?

IF the potential stool donor answers YES to questions 1, 2, or 3 - please STOP.

Do you have a history of any of the following: (Please Circle)

Hepatitis A YES / NO Hemophilia YES / NO Hemodialysis treatment YES / NO Rejected or refused blood donation YES / NO HIV/AIDS YES / NO Hepatitis B YES / NO Hepatitis C YES / NO Use of intravenous drugs or medications YES / NO Incarceration YES / NO Abnormal blood tests of liver enzymes YES / NO Accepting money or drugs in exchange for sex YES / NO Receipt of a blood transfusion between 1977 - 1992 YES / NO Infectious gastroenteritis or diarrhea YES / NO

Did you answer YES to any of the above? YES / NO

Table 3: Required stool donor screening laboratory studies prior to FMT

Stool:

Giardia & Cryptosporidium stool antigen testing Stool ova & parasite testing Cultures for Salmonella, Shigella and E. coli O157:H7 Clostridium difficile toxin B PCR assay

Blood:

HIV 1&2 Ab/Ag HAV IgM Ab HBV core Ab & Ag HCV Ab HTLV-1 Ab

Table 4: Laboratory studies every 120 days for designated stool donors

Stool:

Giardia & Cryptosporidium stool antigen testing Stool ova & parasite testing Cultures for Salmonella, Shigella and E. coli O157:H7 Clostridium difficile toxin B PCR assay

Blood:

HIV 1&2 Ab/Ag HAV IgM Ab HBV core Ab & Ag HCV Ab HTLV-1 Ab


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): NCT01973465


Contacts
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Contact: April A Howarter, BSN 309-624-2409 April.a.howarter@osfhealthcare.org

Locations
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United States, Illinois
OSF Saint Francis Medical Center Recruiting
Peoria, Illinois, United States, 61637
Sponsors and Collaborators
OSF Healthcare System
Investigators
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Principal Investigator: John J Farrell, M.D. OSF Healthcare System

Publications:
Hall IC, O'Toole E. Intestinal flora in newborn infants with a description of a new pathogenic anaerobe, Bacillus difficilis. Am J Dis Child 1935;49:390-402.
True E, Tsoraides S, Bonello JP. Fecal Microbiota Therapy in the Treatment of Clostridium difficile diarrhea. 63rd Annual Scientific Meeting, Illinois Chapter, American College of Surgeons. June 7, 2013.
Sax, PE. NEJM Journal Watch. http://blogs.jwatch.org/hiv-id-observations/index.php/fda-fecal- transplants-need-investigational-new-drug-application/2013/05/12/

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Responsible Party: John Farrell, John Farrell M.D., OSF Healthcare System
ClinicalTrials.gov Identifier: NCT01973465     History of Changes
Other Study ID Numbers: OSF-13-003
First Posted: October 31, 2013    Key Record Dates
Last Update Posted: October 31, 2013
Last Verified: October 2013

Keywords provided by John Farrell, OSF Healthcare System:
C-Diff
Diarrhea

Additional relevant MeSH terms:
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Clostridium Infections
Enterocolitis, Pseudomembranous
Colitis
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
Intestinal Diseases
Gram-Positive Bacterial Infections
Bacterial Infections
Enterocolitis