Clostridium Difficile InfectionPhase 4NCT04090346
Fecal Microbiota Transplant
A Phase 4 study testing Fecal Microbiota Transplant in people with Clostridium Difficile Infection, run by Methodist Health System at 1 site in United States.
Trial summary
The study will provide data to show the effectiveness of Fecal Microbiota Transplant in patients with recurrent Clostridium difficile infection. Fecal Microbiota Transplant (FMT) is a procedure in which healthy colon contents of a carefully screened donor is inserted into the colon of a compromised patient. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Clostridium Difficile Infection
- What is being tested?
- Fecal Microbiota Transplant
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Jun 2018to 30 Mar 2022
- Phase
- Phase 4
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Recurring CDI after three episodes of mild to moderate C Diff infections and failure to respond to appropriate antimicrobial treatment of six to eight weeks.
- Metronidazole
- Vancomycin
- At least two episodes of severe C diff infection that have required hospitalization and significant morbidity within one year
- Severe C Diff infection requiring hospitalization and non- responsive to maximal medication therapy
Who cannot join
- advanced Human Immunodeficiency Virus (HIV) or Acquired Immunodeficiency Syndrome (AIDS)
- cirrhosis of the liver
- recent bone marrow transplants
- medication suppressed immune systems (allowed per physician discretion if benefit outweighs risk)
- pregnancy
- Toxic megacolon or ileus present
Trial locations and contacts
1 site in 1 country.
United States1 site
Methodist Mansfield Medical Center
Dallas, Texas, 75203
About this study
The study will provide data to show the effectiveness of Fecal Microbiota Transplant in patients with recurrent Clostridium difficile infection.
Fecal Microbiota Transplant (FMT) is a procedure in which healthy colon contents of a carefully screened donor is inserted into the colon of a compromised patient. FMT is a procedure to replace beneficial bacteria that has been killed or suppressed, most commonly by use of antibiotics. Currently it is utilized as an experimental treatment for Clostridium difficile infection (CDI). This procedure is predicted to reduce the cost both financially and physically for the CDI patient and facility.
Read the detailed description
Methodist Health System wishes to offer transplant services to our CDI populations which meet all criteria for recurrent intractable disease. The objective is to reduce the cost both financially and physically to patients and the facility, of living with chronic or recurrent CDI disease. This study is to provide treatment and demonstrate documented outcomes and success rates in a manner that protects both the patients and the facility. Of note this treatment is currently being provided by many facilities in Texas, under the FDA Investigational New Drug (IND) enforcement discretion.
The study will provide data to show the effectiveness of Fecal Microbiota Transplant in patients with recurrent Clostridium difficile infection. This study will only examine FMT as it is the only available therapy beyond antibiotic treatment. When patients are considered for FMT they have already failed traditional therapeutic medications.
Patients will be required to meet a specified criteria set forth for chronic or severe CDI infection. Chronic infection is defined as the third or greater episode of C Difficile infection, proven by a positive stool assay with previous documented treatments. Patients must be first treated with first line drug therapies which include vancomycin, metronidazole or fidaxomicin without cure. They must have been treated with at least one course of drugs over a six to eight week period of a vancomycin taper or vancomycin treatment followed by rifaximin for two weeks. Severe CDI infection is defined as refractory moderate to severe CDI diarrhea, with failing vancomycin drug therapy.
Patients with contraindicated co-morbidities will be excluded. Comorbidities include severe bowel disease which would preclude colonoscopy, severe underlying immune suppression or decompensated liver cirrhosis.
Patients will be under the care of a physician who is an identified investigator (sub-investigator) of this study for preparation, procedure and follow up care. Patients will be counseled by this physician regarding the risks and side effects of the procedure and transplant. Staff will only reinforce details from written materials given to patients. Questions outside of the written materials will be directed to the investigators for follow up.
Risks include, but are not limited to the following.
- Transplant making no improvement in the course of their CDI.
- Common side effects including transient gas, bloating and rectal irritation
- Surgical risks which can include blood clots, excessive bleeding, allergic reactions and death. More common surgical risks are infection, drug reactions, bleeding, and perforation.
- Transmission of antibiotic-resistant bacteria: These are resistant to one or more antibiotics. These bacteria could be transmitted through FMT and cause a serious infection. The FMT that you will receive is provided by a company called OpenBiome, where donors who provide stool for the FMT treatments undergo screening for certain antibiotic-resistant bacteria and clinical risk factors that would make their exposure to antibiotic resistant bacteria more likely. Individuals who test positive for these bacteria or have these risk factors are excluded from donating.
Patients will sign three informed consents. The first consent is to acknowledge the basis of the treatment is part of a research study (exhibit 1). The second consent) specifies that FMT is experimental in nature, and reviews the potential risks and benefits of the transplant. The third is the Methodist Health System "Disclosure and Consent" that is used for colonoscopy procedures.
- Conditions
- Clostridium Difficile Infection
- Being tested
- Fecal Microbiota Transplant
- Keywords
- CDiff, Fecal Microbiota Transplant, Infection Control, Antibiotic Stewardship
- 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 Microbiota TransplantDrug
Also called FMT
Fecal Microbiota Transplant (FMT) is a procedure to replace beneficial bacteria which has been killed or suppressed in the colon.
| Study group | Role | What they receive |
|---|---|---|
| Clostridium difficile infection | Experimental | Clostridium difficile infection (CDI) is due to a toxin-producing bacteria that causes a more severe form of antibiotic associated diarrhea. The disease ranges from mild diarrhea to severe colon inflammation that can even be fatal. Receives: Drug: Fecal Microbiota Transplant |
What is being measured
The primary outcome is the main question the study is designed to answer.
treatment date
date of treatment
Measured: eight weeks following transplant.
material volume
volume of material
Measured: eight weeks following transplant.
severity and type of CDI
severity and type of CDI
Measured: eight weeks following transplant.
serious adverse reactions
serious adverse reactions
Measured: eight weeks following transplant.
repeat transplant, colectomy and antibiotics
patients who require additional treatment
Measured: eight weeks following transplant.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2019
- Study start5 Jun 2018
- Primary completion30 Mar 2022
- Study completion30 Mar 2022
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.
- 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Methodist Health System
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Muhammad Memon, MD, Principal investigator, Methodist Mansfield Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04090346
- Sponsor's protocol ID
- 010.GID.2018.A
- Status last verified
- Nov 2021
- First submitted
- 12 Aug 2019
- Last updated
- 24 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fecal Microbiota Transplant
- ClinicalTrials.gov ID
- NCT04090346
- Acronym / sponsor ID
- 010.GID.2018.A
- Conditions
- Clostridium Difficile Infection
- Keywords
- CDiff, Fecal Microbiota Transplant, Infection Control, Antibiotic Stewardship
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Methodist Health SystemUniversity, hospital or other
- Study start
- 5 Jun 2018 (actual)
- Primary completion
- 30 Mar 2022 (actual)
- Study completion
- 30 Mar 2022 (actual)
- First posted
- 16 Sep 2019 (actual)
- 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 study will provide data to show the effectiveness of Fecal Microbiota Transplant in patients with recurrent Clostridium difficile infection.
Fecal Microbiota Transplant (FMT) is a procedure in which healthy colon contents of a carefully screened donor is inserted into the colon of a compromised patient. FMT is a procedure to replace beneficial bacteria that has been killed or suppressed, most commonly by use of antibiotics. Currently it is utilized as an experimental treatment for Clostridium difficile infection (CDI). This procedure is predicted to reduce the cost both financially and physically for the CDI patient and facility.
Detailed description
Methodist Health System wishes to offer transplant services to our CDI populations which meet all criteria for recurrent intractable disease. The objective is to reduce the cost both financially and physically to patients and the facility, of living with chronic or recurrent CDI disease. This study is to provide treatment and demonstrate documented outcomes and success rates in a manner that protects both the patients and the facility. Of note this treatment is currently being provided by many facilities in Texas, under the FDA Investigational New Drug (IND) enforcement discretion.
The study will provide data to show the effectiveness of Fecal Microbiota Transplant in patients with recurrent Clostridium difficile infection. This study will only examine FMT as it is the only available therapy beyond antibiotic treatment. When patients are considered for FMT they have already failed traditional therapeutic medications.
Patients will be required to meet a specified criteria set forth for chronic or severe CDI infection. Chronic infection is defined as the third or greater episode of C Difficile infection, proven by a positive stool assay with previous documented treatments. Patients must be first treated with first line drug therapies which include vancomycin, metronidazole or fidaxomicin without cure. They must have been treated with at least one course of drugs over a six to eight week period of a vancomycin taper or vancomycin treatment followed by rifaximin for two weeks. Severe CDI infection is defined as refractory moderate to severe CDI diarrhea, with failing vancomycin drug therapy.
Patients with contraindicated co-morbidities will be excluded. Comorbidities include severe bowel disease which would preclude colonoscopy, severe underlying immune suppression or decompensated liver cirrhosis.
Patients will be under the care of a physician who is an identified investigator (sub-investigator) of this study for preparation, procedure and follow up care. Patients will be counseled by this physician regarding the risks and side effects of the procedure and transplant. Staff will only reinforce details from written materials given to patients. Questions outside of the written materials will be directed to the investigators for follow up.
Risks include, but are not limited to the following.
- Transplant making no improvement in the course of their CDI.
- Common side effects including transient gas, bloating and rectal irritation
- Surgical risks which can include blood clots, excessive bleeding, allergic reactions and death. More common surgical risks are infection, drug reactions, bleeding, and perforation.
- Transmission of antibiotic-resistant bacteria: These are resistant to one or more antibiotics. These bacteria could be transmitted through FMT and cause a serious infection. The FMT that you will receive is provided by a company called OpenBiome, where donors who provide stool for the FMT treatments undergo screening for certain antibiotic-resistant bacteria and clinical risk factors that would make their exposure to antibiotic resistant bacteria more likely. Individuals who test positive for these bacteria or have these risk factors are excluded from donating.
Patients will sign three informed consents. The first consent is to acknowledge the basis of the treatment is part of a research study (exhibit 1). The second consent) specifies that FMT is experimental in nature, and reviews the potential risks and benefits of the transplant. The third is the Methodist Health System "Disclosure and Consent" that is used for colonoscopy procedures.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Clostridium difficile infection | Experimental | Drug: Fecal Microbiota TransplantClostridium difficile infection (CDI) is due to a toxin-producing bacteria that causes a more severe form of antibiotic associated diarrhea. The disease ranges from mild diarrhea to severe colon inflammation that can even be fatal. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Recurring CDI after three episodes of mild to moderate C Diff infections and failure to respond to appropriate antimicrobial treatment of six to eight weeks.
- Metronidazole
- Vancomycin
- At least two episodes of severe C diff infection that have required hospitalization and significant morbidity within one year
- Severe C Diff infection requiring hospitalization and non- responsive to maximal medication therapy
Key exclusion criteria (6 listed)
- advanced Human Immunodeficiency Virus (HIV) or Acquired Immunodeficiency Syndrome (AIDS)
- cirrhosis of the liver
- recent bone marrow transplants
- medication suppressed immune systems (allowed per physician discretion if benefit outweighs risk)
- pregnancy
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 Microbiota TransplantAlso: FMTFecal Microbiota Transplant (FMT) is a procedure to replace beneficial bacteria which has been killed or suppressed in the colon. | Drug | Clostridium difficile infection |
Primary outcome
treatment date
Time frame: eight weeks following transplant.
date of treatment
material volume
Time frame: eight weeks following transplant.
volume of material
severity and type of CDI
Time frame: eight weeks following transplant.
severity and type of CDI
serious adverse reactions
Time frame: eight weeks following transplant.
serious adverse reactions
repeat transplant, colectomy and antibiotics
Time frame: eight weeks following transplant.
patients who require additional treatment
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 24 Mar 2026.
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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.
Muhammad Memon, MD principal investigator
Methodist Mansfield Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Fecal Microbiota Transplant in people with Clostridium Difficile Infection, run by Methodist Health System 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 5 inclusion and 6 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 24 Mar 2026. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
treatment date (time frame: eight weeks following transplant.). The study lists 5 primary outcomes in all. 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 24 Mar 2026.