Fecal Microbiota Therapy for Recurrent Clostridium Difficile Colitis

NCT01973465 | Unknown

• 1 other identifier: OSF-13-003
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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This study was developed in response to the July, 2013 FDA draft guidance regarding FMT for CDI.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.

Conditions

Clostridium Difficile

Keywords

C-Diff; Diarrhea

Outcome Measures

Primary Outcomes (1)

• Weight and Number of bowel movements/day

  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.

  30 and 90 days

Secondary Outcomes (2)

• Evaluate the most appropriate patient population for FMT

  30 and 90 days

• Determine the overall success of FMT

  30 and 90 days

Study Arms (1)

Fecal Microbiota Therapy

EXPERIMENTAL

Biological: Stool

Interventions

Stool BIOLOGICAL

Implanting fecal matter via colonscope

Fecal Microbiota Therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients \> 18 years of age
• The patient has been treated with appropriate antimicrobial therapy for CDI.
• The patient has documented relapse/recurrence of infection as demonstrated by positive stool culture, or cytotoxin assay, or PCR toxin assay.
• 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.

You may not qualify if:

• Patient is \< 18 years of age
• Patient has an absolute neutrophil count \< 750 cells/mm3.
• Stool donors must:
• be \> 18 years of age
• Complete a screening questionnaire:
• a. One-time donors: Table 1 b. Designated, pre-screened donors: Table 2
• Be tested for communicable blood-borne and enteric pathogens:
• One-time donors: Table 3
• 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
• Have you ever been diagnosed with Clostridium difficile colitis?
• Are you currently taking antibiotic medications?

Sponsors & Collaborators

• OSF Healthcare System: lead

Study Sites (1)

OSF Saint Francis Medical Center

Peoria, Illinois, 61637, United States

RECRUITING

Related Publications (6)

• 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.

  BACKGROUND

• Bartlett JG, Chang TW, Gurwith M, Gorbach SL, Onderdonk AB. Antibiotic-associated pseudomembranous colitis due to toxin-producing clostridia. N Engl J Med. 1978 Mar 9;298(10):531-4. doi: 10.1056/NEJM197803092981003.

  PMID: 625309 BACKGROUND

• van Nood E, Vrieze A, Nieuwdorp M, Fuentes S, Zoetendal EG, de Vos WM, Visser CE, Kuijper EJ, Bartelsman JF, Tijssen JG, Speelman P, Dijkgraaf MG, Keller JJ. Duodenal infusion of donor feces for recurrent Clostridium difficile. N Engl J Med. 2013 Jan 31;368(5):407-15. doi: 10.1056/NEJMoa1205037. Epub 2013 Jan 16.

  PMID: 23323867 BACKGROUND

• Gough E, Shaikh H, Manges AR. Systematic review of intestinal microbiota transplantation (fecal bacteriotherapy) for recurrent Clostridium difficile infection. Clin Infect Dis. 2011 Nov;53(10):994-1002. doi: 10.1093/cid/cir632.

  PMID: 22002980 BACKGROUND

• 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.

  BACKGROUND

• 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/

  BACKGROUND

MeSH Terms

Conditions

Diarrhea

Interventions

Defecation

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Digestive System Physiological Phenomena; Digestive System and Oral Physiological Phenomena

Study Officials

• John J Farrell, M.D.

  OSF Healthcare System

  PRINCIPAL INVESTIGATOR

Central Study Contacts

April A Howarter, BSN

CONTACT

309-624-2409; April.a.howarter@osfhealthcare.org

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: John Farrell M.D.

Study Record Dates

• First Submitted: October 21, 2013
• First Posted: October 31, 2013
• Study Start: September 1, 2013
• Primary Completion: September 1, 2014
• Study Completion: September 1, 2014
• Last Updated: October 31, 2013

Record last verified: 2013-10

Locations

US (1)