Clostridium Difficile InfectionFMTNCT02326636
Fecal Microbiota Transplant for Recurrent Clostridium Difficile Infection
An observational study of Clostridium Difficile Infection, run by University of California, Irvine at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Clostridium Difficile Infection
- What is being tested?
- Fecal Microbial Transplantation
- How many people
- 37 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2014to 26 Oct 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who are referred for recurrent Clostridium difficile infections. Donors will be identified by the Recipient.
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California, Irvine Medical Center
Orange, California, 92868
About this study
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
- Being tested
- Fecal Microbial Transplantation
- Medical subject headings
- Clostridium Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fecal Microbial TransplantationBiological
Participants with refractory Clostridium difficile infection will be given healthy donor stool administered by colonoscopy or enema.
What is being measured
The primary outcome is the main question the study is designed to answer.
The recurrence rate of Clostridium difficile 4 weeks after FMT.
Measured: Four weeks
Secondary outcomes (5)
Clinical symptoms from before fecal microbiota transplant (FMT) to 4 weeks after FMT.
Measured: Four weeks
Satisfaction with the FMT procedure. ( satisfaction questionnaire )
Subjects will complete a satisfaction questionnaire following the FMT procedure.
Measured: Up to 24 weeks
Quality of life before and 4 weeks after FMT.
Subjects will complete a quality of life questionnaire before and 4 weeks after FMT.
Measured: Four weeks
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.
Measured: Up to 24 weeks
The rate of adverse events that may be related to FMT.
Measured: Up to 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2014 (estimated)
- Study startApr 2014
- Primary completion26 Oct 2018
- Study completion26 Oct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Clostridium Difficile InfectionStudies of the same condition, open and under way.
- More trials run by University of California, IrvineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Irvine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nimisha Parekh, University of California, Irvine
- Investigators
- Nimisha Parekh, MD, Principal investigator, University of California, Irvine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02326636
- Sponsor's protocol ID
- 20139455
- Acronym
- FMT
- Status last verified
- Aug 2023
- First submitted
- 9 Dec 2014
- Last updated
- 21 Aug 2023
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fecal Microbiota Transplant for Recurrent Clostridium Difficile Infection
- ClinicalTrials.gov ID
- NCT02326636
- Acronym / sponsor ID
- FMT / 20139455
- Conditions
- Clostridium Difficile Infection
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- University of California, IrvineUniversity, hospital or other
- Study start
- Apr 2014
- Primary completion
- 26 Oct 2018 (actual)
- Study completion
- 26 Oct 2018 (actual)
- First posted
- 29 Dec 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who are referred for recurrent Clostridium difficile infections. Donors will be identified by the Recipient.
Key inclusion criteria (13 listed)
- 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.
- Metronidazole 500 mg three times a day for 10 to 14 days
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fecal Microbial TransplantationParticipants with refractory Clostridium difficile infection will be given healthy donor stool administered by colonoscopy or enema. | Biological | – |
Primary outcome
The recurrence rate of Clostridium difficile 4 weeks after FMT.
Time frame: Four weeks
5 secondary outcomes
Clinical symptoms from before fecal microbiota transplant (FMT) to 4 weeks after FMT.
Time frame: Four weeks
Satisfaction with the FMT procedure. ( satisfaction questionnaire )
Time frame: Up to 24 weeks
Quality of life before and 4 weeks after FMT.
Time frame: Four weeks
Alternate treatments needed for Clostridium difficile before and after FMT.
Time frame: Up to 24 weeks
The rate of adverse events that may be related to FMT.
Time frame: Up to 24 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nimisha Parekh, MD principal investigator
University of California, Irvine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Clostridium Difficile Infection, run by University of California, Irvine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The recurrence rate of Clostridium difficile 4 weeks after FMT. (time frame: Four weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2023.