Fecal Microbiota Transplant for Recurrent Clostridium Difficile Infection

NCT ID: NCT02326636

Last Updated: 2023-08-21

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 37 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2014-04-30
• Study Completion Date: 2018-10-26

Brief 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.

Conditions

Clostridium Difficile Infection

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

Fecal Microbial Transplantation

Participants with refractory Clostridium difficile infection will be given healthy donor stool administered by colonoscopy or enema.

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

• 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

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of California, Irvine

OTHER

Sponsor Role: lead

Responsible Party

Nimisha Parekh

Associate Clinical Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Nimisha Parekh, MD

Role: PRINCIPAL_INVESTIGATOR

University of California, Irvine

Locations

University of California, Irvine Medical Center

Orange, California, United States

Countries

United States

Other Identifiers

20139455

Identifier Type: -

Identifier Source: org_study_id