Clostridium Difficile InfectionPhase 1NCT01704937
Fecal Microbiota Transplant (FMT) for Relapsing C. Difficile Infection in Adults and Children Using a Frozen Inoculum
A Phase 1 study testing Fecal Microbiota Transplant (FMT) in people with Clostridium Difficile Infection, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
Fecal microbiota transplantation (FMT) is the reconstitution of normal flora by a "stool transplant" from a healthy individual to a C. difficile-infected recipient, and has long been a successful approach to recurrent/refractory C. difficile. Read more about this study
- Who is it for?
- Ages 7 to 90 years
- Conditions the study is for
- Clostridium Difficile Infection
- What is being tested?
- Fecal Microbiota Transplant (FMT)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2012to May 2014
- Phase
- Phase 1
- 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 7 to 90 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients with recurrent or relapsing CDI defined as EITHER(13):
- At least three episodes of mild-to-moderate CDI and failure of a 6-8 week taper with vancomycin with or without an alternative antibiotic (e.g. rifaximin, nitazoxanide).
- At least two episodes of severe CDI resulting in hospitalization and associated with significant morbidity.
- Willingness to accept risk of unrelated donor stool
- Willingness to be randomized to NGT vs. colonoscopic delivery.
- Able to consent for self, or parental assent/child assent as age appropriate.
Who cannot join
- Anatomic contraindication to NGT
- Delayed gastric emptying syndrome
- Known chronic aspiration
- Contraindication to colonoscopy (ASA 4 or more)
- High risk of bacterial translocation (Immunosuppression, cirrhosis etc)
- Pregnant or breastfeeding women
- Acute unrelated infection or comorbid illness exaccerbation
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02114
About this study
Fecal microbiota transplantation (FMT) is the reconstitution of normal flora by a "stool transplant" from a healthy individual to a C. difficile-infected recipient, and has long been a successful approach to recurrent/refractory C. difficile. The purpose of this project is to generate a frozen FMT inoculum from well-screened healthy volunteer donors which can be used repeatedly, particularly in those who do not have a healthy intimate partner or other related donor. Delivery of FMT has been performed colonoscopically, by fecal retention enema, or by the nasogastric route. This study will evaluate the safety and secondarily the efficacy of a frozen inoculum administered by nasogastric tube vs administered by colonoscope.
Subjects with recurrent/relapsing C. difficile infection (10 per group) will receive FMT via either:
Read more
- colonoscopy
- NGT
The primary endpoint is assessment of safety as measured by clinical events (GI, procedural, systemic). Efficacy will be defined as a resolution of diarrhea off antibiotics for C. difficile, in the absence of a need for OTHER systemic antibiotics, i.e. resumption of a normal bowel status for the individual. Secondary efficacy endpoints include weight, subjective well-being and relative clinical improvement per standardized questionnaire, and subject qualitative assessment of, and satisfaction with, the transplant procedures. Subjects will be monitored for clinical safety by history and standard exams and the follow-up questionnaire as well as followed closely by phone and in person.
- Conditions
- Clostridium Difficile Infection
- Being tested
- Fecal Microbiota Transplant (FMT)
- Keywords
- Fecal Microbiota Transplant, Clostridium difficile, Diarrhea
- Medical subject headings
- Clostridium Infections, Diarrhea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fecal Microbiota Transplant (FMT)Drug
Reconstitution of normal flora by a "stool transplant" from a healthy individual to a C. difficile - infected recipient via colonoscopy or nasogastric tube
| Study group | Role | What they receive |
|---|---|---|
| Colonoscopy | Experimental | Fecal microbiota transplant ("stool transplant") from healthy, unrelated donor via colonoscopy Receives: Drug: Fecal Microbiota Transplant (FMT) |
| Nasogastric Tube (NGT) | Experimental | Fecal microbiota transplant ("stool transplant") from healthy, unrelated donor via NGT Receives: Drug: Fecal Microbiota Transplant (FMT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety
Safety is assessed by clinical symptoms, exam, signs (GI and systemic)
Measured: up to 6 mo post FMT
Secondary outcomes (1)
Efficacy
Efficacy is defined as resolution of C. Difficile signs and symptoms off antibiotics for C. difficile
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2012 (estimated)
- Study startNov 2012
- Primary completionMay 2014
- Study completionMay 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Clostridium Difficile InfectionStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe 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
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elizabeth L. Hohmann, MD, Massachusetts General Hospital
- Investigators
- Elizabeth L Hohmann, MD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01704937
- Sponsor's protocol ID
- 2012-P-001657
- Status last verified
- Jun 2014
- First submitted
- 4 Oct 2012
- Last updated
- 20 Jun 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Youngster I, Sauk J, Pindar C, Wilson RG, Kaplan JL, Smith MB, Alm EJ, Gevers D, Russell GH, Hohmann EL. Fecal microbiota transplant for relapsing Clostridium difficile infection using a frozen inoculum from unrelated donors: a randomized, open-label, controlled pilot study. Clin Infect Dis. 2014 Jun;58(11):1515-22. doi: 10.1093/cid/ciu135. Epub 2014 Apr 23.
PubMed 24762631
Study at a glance
From the registry record, last updated by the sponsor on 20 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fecal Microbiota Transplant (FMT) for Relapsing C. Difficile Infection in Adults and Children Using a Frozen Inoculum
- ClinicalTrials.gov ID
- NCT01704937
- Acronym / sponsor ID
- 2012-P-001657
- Conditions
- Clostridium Difficile Infection
- Keywords
- Fecal Microbiota Transplant, Clostridium difficile, Diarrhea
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- Nov 2012
- Primary completion
- May 2014 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 12 Oct 2012 (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.
Fecal microbiota transplantation (FMT) is the reconstitution of normal flora by a "stool transplant" from a healthy individual to a C. difficile-infected recipient, and has long been a successful approach to recurrent/refractory C. difficile. The purpose of this project is to generate a frozen FMT inoculum from well-screened healthy volunteer donors which can be used repeatedly, particularly in those who do not have a healthy intimate partner or other related donor. Delivery of FMT has been performed colonoscopically, by fecal retention enema, or by the nasogastric route. This study will evaluate the safety and secondarily the efficacy of a frozen inoculum administered by nasogastric tube vs administered by colonoscope.
Subjects with recurrent/relapsing C. difficile infection (10 per group) will receive FMT via either:
- colonoscopy
- NGT
The primary endpoint is assessment of safety as measured by clinical events (GI, procedural, systemic). Efficacy will be defined as a resolution of diarrhea off antibiotics for C. difficile, in the absence of a need for OTHER systemic antibiotics, i.e. resumption of a normal bowel status for the individual. Secondary efficacy endpoints include weight, subjective well-being and relative clinical improvement per standardized questionnaire, and subject qualitative assessment of, and satisfaction with, the transplant procedures. Subjects will be monitored for clinical safety by history and standard exams and the follow-up questionnaire as well as followed closely by phone and in person.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Colonoscopy | Experimental | Drug: Fecal Microbiota Transplant (FMT)Fecal microbiota transplant ("stool transplant") from healthy, unrelated donor via colonoscopy |
| Nasogastric Tube (NGT) | Experimental | Drug: Fecal Microbiota Transplant (FMT)Fecal microbiota transplant ("stool transplant") from healthy, unrelated donor via NGT |
Who may qualify
- Ages
- 7 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Patients with recurrent or relapsing CDI defined as EITHER(13):
- Willingness to accept risk of unrelated donor stool
- Willingness to be randomized to NGT vs. colonoscopic delivery.
- Able to consent for self, or parental assent/child assent as age appropriate.
Key exclusion criteria (7 listed)
- Anatomic contraindication to NGT
- Delayed gastric emptying syndrome
- Known chronic aspiration
- Contraindication to colonoscopy (ASA 4 or more)
- High risk of bacterial translocation (Immunosuppression, cirrhosis etc)
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 Transplant (FMT)Reconstitution of normal flora by a "stool transplant" from a healthy individual to a C. difficile - infected recipient via colonoscopy or nasogastric tube | Drug | Colonoscopy, Nasogastric Tube (NGT) |
Primary outcome
Safety
Time frame: up to 6 mo post FMT
Safety is assessed by clinical symptoms, exam, signs (GI and systemic)
1 secondary outcome
Efficacy
Time frame: 3 months
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 20 Jun 2014.
- Results publication: PubMed 24762631Youngster I, Sauk J, Pindar C, Wilson RG, Kaplan JL, Smith MB, Alm EJ, Gevers D, Russell GH, Hohmann EL. Fecal microbiota transplant for relapsing Clostridium difficile infection using a frozen inoculum from unrelated donors: a randomized, open-label, controlled pilot study. Clin Infect Dis. 2014 Jun;58(11):1515-22. doi: 10.1093/cid/ciu135. Epub 2014 Apr 23.
Related trials for Clostridium Difficile Infection
Not yet recruitingObservational study
Epidemiology of Clostridioides Difficile Infection (CDI) in Long-term Care Facilities, Assessment of Professional Practices Related to CDI Risk Prevention, and Strategies for Improving Care.
Clostridioides Difficile Infection
Active, not recruitingPhase 2
Autologous Fecal Microbiota Transplantation (Auto-FMT) for Prophylaxis of Clostridium Difficile Infection in Recipients of Allogeneic Hematopoietic Stem Cell Transplantation
Allogeneic Hematopoietic Stem Cell
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
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.
Elizabeth L Hohmann, MD principal investigator
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Fecal Microbiota Transplant (FMT) in people with Clostridium Difficile Infection, run by Massachusetts General Hospital 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 6 inclusion and 7 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 20 Jun 2014. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Safety (time frame: up to 6 mo post FMT). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01704937, which also lists 1 linked publication.
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 Jun 2014.