Fecal Microbiota Transplant for Recurrent Clostridium Difficile Infection

NCT02326636 | Completed DMC

• 1 other identifier: 20139455
• Study Type: observational
• Target: 37
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• The recurrence rate of Clostridium difficile 4 weeks after FMT.

  Four weeks

Secondary Outcomes (5)

• Clinical symptoms from before fecal microbiota transplant (FMT) to 4 weeks after FMT.

  Four weeks

• Satisfaction with the FMT procedure. ( satisfaction questionnaire )

  Up to 24 weeks

• Quality of life before and 4 weeks after FMT.

  Four weeks

• Alternate treatments needed for Clostridium difficile before and after FMT.

  Up to 24 weeks

• The rate of adverse events that may be related to FMT.

  Up to 24 weeks

Interventions

Fecal Microbial Transplantation BIOLOGICAL

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

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients who are referred for recurrent Clostridium difficile infections. Donors will be identified by the Recipient.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, Irvine: lead

Study Sites (1)

University of California, Irvine Medical Center

Orange, California, 92868, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

A donor stool sample will be kept for future testing in case of contamination.

MeSH Terms

Conditions

Clostridium Infections

Condition Hierarchy (Ancestors)

Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Study Officials

• Nimisha Parekh, MD

  University of California, Irvine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Clinical Professor

Study Record Dates

• First Submitted: December 9, 2014
• First Posted: December 29, 2014
• Study Start: April 1, 2014
• Primary Completion: October 26, 2018
• Study Completion: October 26, 2018
• Last Updated: August 21, 2023

Record last verified: 2023-08

Locations

US (1)