Fecal Microbiota Transplant for Recurrent Clostridium Dif... | NCT02326636

Studies
Fecal Microbiota Transplant for Recurrent Clostridium Difficile Infection

NCT02326636

Sponsor

University of California, Irvine

Status

Completed

Last Update Posted

Aug 21, 2023Actual

Enrollment

37Actual

Phase

Not provided

Conditions

Clostridium Difficile Infection

Interventions

Fecal Microbial Transplantation

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2014

Primary Completion Date

Oct 26, 2018Actual

Completion Date

Oct 26, 2018Actual

First Submitted Date

Dec 9, 2014

First Submission Date that Met QC Criteria

Dec 26, 2014

First Posted Date

Dec 29, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 16, 2023

Last Update Posted Date

Aug 21, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

37Actual

Name	Type	Description	Arm Group Labels	Other Names
Fecal Microbial Transplantation	Biological	Participants with refractory Clostridium difficile infection will be given healthy donor stool administered by colonoscopy or enema.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The recurrence rate of Clostridium difficile 4 weeks after FMT.		Four weeks

Secondary Outcomes

Measure	Description	Time Frame
Clinical symptoms from before fecal microbiota transplant (FMT) to 4 weeks after FMT.		Four weeks
Satisfaction with the FMT procedure. ( satisfaction questionnaire )	Subjects will complete a satisfaction questionnaire following the FMT procedure.

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

100 Years

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

ID	Term
D016908	Gram-Positive Bacterial Infections
D001424	Bacterial Infections
D001423	Bacterial Infections and Mycoses
D007239	Infections