Fecal Microbiota Transplant for Recurrent Clostridium Difficile Infection

Clostridium Difficile Infection Clinical Trial

— FMT  

Official title:

Fecal Microbiota Transplant for Recurrent Clostridium Difficile Infection

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02326636
• Other study ID #: 20139455
• Status: Completed
• Start date: April 2014
• Est. completion date: October 26, 2018

Study information

• Verified date: August 2023
• Source: University of California, Irvine
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The purpose of this research is to investigate the efficacy of transplanting screened donor fecal material in treating patients with recurrent Clostridium difficile infection. Participants with refractory Clostridium difficile infection will be given healthy donor stool administered by colonoscopy or enema and their response will be evaluated by symptom questionnaire and stool testing for Clostridium difficile at 4 weeks after the treatment.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 37
• Est. completion date: October 26, 2018
• Est. primary completion date: October 26, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

Inclusion Criteria for Recipient:

• Between the age of 18 and 100
• Have positive Clostridium difficile polymerase chain reaction (PCR) or toxin
• Have symptoms of > 3 watery loose stools a day for at least 2 consecutive days
• Have failed at least one prior standard course of antibiotic therapy.

Examples of standard therapy are:

• Metronidazole 500 mg three times a day for 10 to 14 days
• Vancomycin 125 mg four times a day for 10 to 14 days
• Not be pregnant and have negative urine and/or serum human chorionic gonadotropin (hCG) test
• Not be taking oral or intravenous steroids in the past three months.
• Not on biologic agents, anti-tumor necrosis factor (anti-TNF) agents, cyclosporine, mercaptopurine, azathioprine, methotrexate or chemotherapy in the preceding 3 months
• Not have profound immunosuppression: Chemotherapy the preceding 3 months, HIV/AIDS, decompensated cirrhosis
• Not be in the Intensive Care Unit
• Not be a transplant recipient

Exclusion Criteria for Recipient:

• Not between the age of 18 and 100
• Does not have positive Clostridium difficile PCR or toxin
• Does not have symptoms of > 3 watery loose stools a day for at least 2 consecutive days
• Has not failed at least one prior standard course of antibiotic therapy. Examples of

standard therapy are:

• Metronidazole 500 mg three times a day for 10 to 14 days
• Vancomycin 125 mg four times a day for 10 to 14 days
• Is pregnant
• Has taken oral or IV steroids in the past three months.
• Has taken biologic agents, anti-TNF agents, cyclosporine, mercaptopurine, azathioprine, methotrexate or chemotherapy in the preceding 3 months
• Has profound immunosuppression: Chemotherapy the preceding 3 months, HIV/AIDS, decompensated cirrhosis
• In the Intensive Care Unit
• Is a transplant recipient

Related Conditions & MeSH terms

• Clostridium Difficile Infection
• Clostridium Infections
• Communicable Diseases
• Infections

Intervention

Biological:
• Fecal Microbial Transplantation
Participants with refractory Clostridium difficile infection will be given healthy donor stool administered by colonoscopy or enema.

Locations

Country	Name	City	State
United States	University of California, Irvine Medical Center	Orange	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, Irvine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The recurrence rate of Clostridium difficile 4 weeks after FMT.		Four weeks
Secondary	Clinical symptoms from before fecal microbiota transplant (FMT) to 4 weeks after FMT.		Four weeks
Secondary	Satisfaction with the FMT procedure. ( satisfaction questionnaire )	Subjects will complete a satisfaction questionnaire following the FMT procedure.	Up to 24 weeks
Secondary	Quality of life before and 4 weeks after FMT.	Subjects will complete a quality of life questionnaire before and 4 weeks after FMT.	Four weeks
Secondary	Alternate treatments needed for Clostridium difficile before and after FMT.	Subjects medication and treatment history for Clostridium difficile before and after FMT will be collected.	Up to 24 weeks
Secondary	The rate of adverse events that may be related to FMT.		Up to 24 weeks