Clostridium Difficile Infection RecurrenceNCT03562741
Outcomes and Data Collection for Fecal Microbiota Transplantation for the Treatment of Recurrent Clostridium Difficile
A study testing Fecal Microbiota Transplantation in people with Clostridium Difficile Infection Recurrence and Clostridium Difficile Infection, run by Krunal Patel at 1 site in United States.
Trial summary
The purpose of this study is to see if stool transplant performed by colonoscopy is effective at treating recurrent Clostridium difficile (C. diff) infection of the colon. During the procedure a stool sample is taken from a healthy donor (usually family member or close friend) and transplanted directly into the colon… Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Clostridium Difficile Infection Recurrence, Clostridium Difficile Infection
- What is being tested?
- Fecal Microbiota Transplantation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Jan 2014to 16 Jan 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Two or more recurrences of C. difficile infection (CDI) with recurrence defined as a positive test result, e.g. Polymerase Chain Reaction (PCR) test and with appropriate symptoms within 2-8 weeks of last positive result, provided that symptoms from earlier episode resolved with or without therapy.
- Failed standard therapy with oral metronidazole and/or oral vancomycin
- One or more episodes of severe CDI resulting in hospitalization and not responding to standard antibiotic therapy. Hospitalization for CDI occurs in the setting of severe diarrhea, abdominal pain and signs of systemic toxicity
Who cannot join
- Age <16 years old
- patients with acute severe colonic dilation at risk for colonic perforation
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Anne Foley contact
United States1 site, 1 recruiting
- Recruiting
UMass Memorial Medical Center
Worcester, Massachusetts, 01655
Anne Foley, Anne.Foley@umassmed.edu
Krunal Patel, MD
About this study
The purpose of this study is to see if stool transplant performed by colonoscopy is effective at treating recurrent Clostridium difficile (C. diff) infection of the colon. During the procedure a stool sample is taken from a healthy donor (usually family member or close friend) and transplanted directly into the colon of the patient with C. diff infection. The goal of this experimental procedure (called fecal microbiota transplantation) is to replenish the good bacteria in the colon that can help prevent C. diff infection from coming back after treatment.
Read the detailed description
Fecal microbiota transplantation (FMT) involves administering fecal material from a healthy individual into the gastrointestinal tract of the patient. This has been done in the past for recurrent colitis secondary to Clostridium difficile infection (CDI) using different methods such as through nasogastric tube, fecal retention enemas, and by colonoscopy. This method of treatment was introduced over 50 years ago with high success rates, although it has not been until recent that more case studies have been performed, with continued success rates of approximately 90%. Studies have found this therapy to be effective with resolution of symptoms in most patients, and have found it to be both cost effective and safe.
The purpose of this study is to use a standardized published protocol for fecal microbiota transplantation performed by colonoscopy and record the success rate and outcomes of FMT therapy for patients with recurrent CDI at the UMassMemorial Medical Center. In addition, the cost of this therapy will be compared to conventional antibiotic treatment. The reduction in hospitalizations will also be monitored compared with historical controls.
The hypothesis of this study is that FMT therapy will show resolution of infection in most patients with recurrent CDI, with an overall reduction in cost to the hospital for recurrent admissions for Clostridium difficile colitis as compared to historical controls. Historical controls will be defined as patients with recurrent positive Clostridium difficile stool samples treated in the traditional fashion with antibiotics.
- Being tested
- Fecal Microbiota 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 Microbiota TransplantationProcedure or surgery
Transplantation of Screened donor stool as part of Fecal Microbiota Transplantation
| Study group | Role | What they receive |
|---|---|---|
| Fecal Microbiota Transplantation | Experimental | Subjects receive intervention of stool transplanted to the colon via colonoscopy. Receives: Procedure: Fecal Microbiota Transplantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clostridium Difficile (C. diff) resolution'
Longterm resolution of C. diff associated diarrhea after Fecal Microbiota Transplantation (FMT) therapy
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2018
- Study start16 Jan 2014
- Primary completion16 Jan 2028 (estimated)
- Study completion16 Jan 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Clostridium Difficile Infection RecurrenceStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Krunal Patel
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Krunal Patel, University of Massachusetts, Worcester
- Investigators
- Krunal Patel, Principal investigator, UMass Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03562741
- Sponsor's protocol ID
- H00003682
- Status last verified
- Feb 2026
- First submitted
- 7 Jun 2018
- Last updated
- 20 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outcomes and Data Collection for Fecal Microbiota Transplantation for the Treatment of Recurrent Clostridium Difficile
- ClinicalTrials.gov ID
- NCT03562741
- Acronym / sponsor ID
- H00003682
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Krunal PatelUniversity, hospital or other
- Study start
- 16 Jan 2014 (actual)
- Primary completion
- 16 Jan 2028 (estimated)
- Study completion
- 16 Jan 2029 (estimated)
- First posted
- 19 Jun 2018 (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 purpose of this study is to see if stool transplant performed by colonoscopy is effective at treating recurrent Clostridium difficile (C. diff) infection of the colon. During the procedure a stool sample is taken from a healthy donor (usually family member or close friend) and transplanted directly into the colon of the patient with C. diff infection. The goal of this experimental procedure (called fecal microbiota transplantation) is to replenish the good bacteria in the colon that can help prevent C. diff infection from coming back after treatment.
Detailed description
Fecal microbiota transplantation (FMT) involves administering fecal material from a healthy individual into the gastrointestinal tract of the patient. This has been done in the past for recurrent colitis secondary to Clostridium difficile infection (CDI) using different methods such as through nasogastric tube, fecal retention enemas, and by colonoscopy. This method of treatment was introduced over 50 years ago with high success rates, although it has not been until recent that more case studies have been performed, with continued success rates of approximately 90%. Studies have found this therapy to be effective with resolution of symptoms in most patients, and have found it to be both cost effective and safe.
The purpose of this study is to use a standardized published protocol for fecal microbiota transplantation performed by colonoscopy and record the success rate and outcomes of FMT therapy for patients with recurrent CDI at the UMassMemorial Medical Center. In addition, the cost of this therapy will be compared to conventional antibiotic treatment. The reduction in hospitalizations will also be monitored compared with historical controls.
The hypothesis of this study is that FMT therapy will show resolution of infection in most patients with recurrent CDI, with an overall reduction in cost to the hospital for recurrent admissions for Clostridium difficile colitis as compared to historical controls. Historical controls will be defined as patients with recurrent positive Clostridium difficile stool samples treated in the traditional fashion with antibiotics.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Fecal Microbiota Transplantation | Experimental | Procedure: Fecal Microbiota TransplantationSubjects receive intervention of stool transplanted to the colon via colonoscopy. |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Two or more recurrences of C. difficile infection (CDI) with recurrence defined as a positive test result, e.g. Polymerase Chain Reaction (PCR) test and with appropriate symptoms within 2-8 weeks of last positive result, provided that symptoms from earlier episode resolved with or without therapy.
- Failed standard therapy with oral metronidazole and/or oral vancomycin
- One or more episodes of severe CDI resulting in hospitalization and not responding to standard antibiotic therapy. Hospitalization for CDI occurs in the setting of severe diarrhea, abdominal pain and signs of systemic toxicity
Key exclusion criteria (2 listed)
- Age <16 years old
- patients with acute severe colonic dilation at risk for colonic perforation
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 TransplantationTransplantation of Screened donor stool as part of Fecal Microbiota Transplantation | Procedure or surgery | Fecal Microbiota Transplantation |
Primary outcome
Clostridium Difficile (C. diff) resolution'
Time frame: 12 months
Longterm resolution of C. diff associated diarrhea after Fecal Microbiota Transplantation (FMT) therapy
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2026.
- Individual participant dataSharing planned: No
Related trials for Clostridium Difficile Infection Recurrence
Active, not recruitingObservational study
C. Difficile Toxin Levels in Stool From Healthy Individuals Following Standard of Care Antibiotic Treatment for CDI.
Clostridioides Difficile Infection Recurrence
RecruitingPhase 3
VE303 for Prevention of Recurrent Clostridioides Difficile Infection
Clostridium Difficile, Clostridium Difficile Infections
RecruitingEarly Phase 1
Prevention of Recurrence of Clostridioides Difficile Colitis With Ursodeoxycholic Acid (UCDA) as a Supplement to Standard Therapy
Clostridioides Difficile Infection
RecruitingPhase 1/2
Evaluation of EXL01, a New Live Biotherapeutic Product to Prevent Recurrence of Clostridioides Difficile Infection in High-risk Patients
Clostridioides Difficile Infection, Recurrent Infection
RecruitingPhase 2
ACX-362E [Ibezapolstat] for Oral Treatment of Recurrent Clostridioides Difficile Infection
Clostridium Difficile Infection Recurrence
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.
Anne Foley contact
Krunal Patel principal investigator
UMass Medical School
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fecal Microbiota Transplantation in people with Clostridium Difficile Infection Recurrence and Clostridium Difficile Infection, run by Krunal Patel 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 3 inclusion and 2 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: looking for participants now, as of the sponsor's last update on 20 Feb 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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Anne Foley (Anne.Foley@umassmed.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clostridium Difficile (C. diff) resolution' (time frame: 12 months). 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 20 Feb 2026.