Clostridium Difficile InfectionPhase 2NCT02557685
Gut Microbiota Changes After Fecal Microbiota Transplantation
A Phase 2 study testing Fecal Microbiota Transplantation in people with Clostridium Difficile Infection, run by The Miriam Hospital at 1 site in United States.
Trial summary
This study aims to document early changes in the distal gut microbiota (both fecal and mucosa-associated) post FMT. Furthermore, whole blood and urine samples will facilitate collaborative immunologic and metabolomic analyses. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Clostridium Difficile Infection
- What is being tested?
- Fecal Microbiota Transplantation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2015to Mar 2017
- Phase
- Phase 2
- 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 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult outpatients (age ≥18 and ≤90) referred to Dr. Kelly after suffering a third (or further) documented episode CDI and 2) who have failed to maintain CDI cure after standard therapy.
- Previous treatment with at least one course of tapered/pulse dose vancomycin as per SHEA-IDSA C difficile treatment guidelines or
- Inability to taper or stop anti-CDI therapy without developing diarrhea requiring anti-infective therapy
Who cannot join
- • Patients who are pregnant
- Patients who are nursing
- Patients who are incarcerated
- Patients with cognitive impairment or severe neuropsychiatric co morbidities who are incapable of giving their own informed consent
- Patients who are immunocompromised specifically:
- HIV infection (any CD4 count)
Show all 19Show fewer
- AIDS-defining diagnosis or CD4<200/mm3
- Inherited/primary immune disorders
- Immunodeficient or Immunosuppressed due to medical condition/medication:
- Current or recent (<3 most) treatment with anti-neoplastic agent
- Current or recent (<3 mos) treatment with any immunosuppressant medications (including but not limited to monoclonal antibodies to B and T cells, anti-TNF agents, glucocorticoids, antimetabolites (azathioprine, 6-mercaptopurine), calcineurin inhibitors (tacrolimus, cyclosporine), mycophenolate mofetil). Subjects who are otherwise immunocompetent and have discontinued any immunosuppressant medications 3 or more months prior to enrollment may be eligible to enroll.
- Patients with a history of severe (anaphylactic) food allergy
- Patients who have previously undergone FMT
- Patients who are unwilling or unable to undergo sigmoidoscopy
- Patients with untreated, in-situ colorectal cancer
- Patients with a history of inflammatory bowel disease (ulcerative colitis, Crohn's disease or microscopic colitis) or diarrhea-predominant irritable bowel syndrome
- Unable to comply with protocol requirements
- Patients who are American Society of Anesthesiologists (ASA) Physical Status classification IV and V
- Patients with acute illness or fever on the day of planned FMT will be excluded (not undergo randomization or treatment with FMT) with the option of including that subject at a future date.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
The Miriam Hospital
Providence, Rhode Island, 02906
Colleen R. Kelly, MD, 401-793-7080, ckelly2@lifespan.org
Patrizia Curran, MD, 401-793-7824, pcurran1@lifespan.org
About this study
Official title: Alterations in Gut Microbiota and Metabolism Following FMT for Recurrent C. Difficile Infection
This study aims to document early changes in the distal gut microbiota (both fecal and mucosa-associated) post FMT. Furthermore, whole blood and urine samples will facilitate collaborative immunologic and metabolomic analyses.
This will be an open label clinical trial of FMT to prevent further recurrence in patients who have suffered at least a third episode of Clostridium difficile infection (CDI) and who have previously been treated with oral vancomycin.
Read the detailed description
The exact mechanism by which FMT is effective is presently unknown. A recent study of 14 patients with recurrent CDI treated with FMT35 showed decreased diversity pre-FMT with gut microbiota becoming more diverse and similar to donors post-FMT. This group showed significant changes in 3 taxonomic orders but no single organism or species was universally associated with success. Weingarden et al. showed that FMT restored normal bile acid composition in patients with recurrent CDI36, suggesting that correction of bile acid metabolism is likely a major mechanism by which FMT results in a cure and prevents recurrence of CDI. Understanding mechanisms of FMT more completely may enable development of synthetic microbiota-based therapeutics which would be a safe and effective alternative to traditional FMT. We hypothesize that early changes in distal gut microbiota post-FMT may help identify key species associated with efficacy. Furthermore, we believe there are measurable metabolic and immunologic effects which may also be beneficial after FMT. This study aims to document early changes in the distal gut microbiota (both fecal and mucosa-associated) post FMT. Furthermore, whole blood and urine samples will facilitate collaborative immunologic and metabolomic analyses.
This will be an open label clinical trial of FMT to prevent further recurrence in patients who have suffered at least a third episode of Clostridium difficile infection (CDI) and who have previously been treated with oral vancomycin. Subjects will consist of 6 adult outpatients referred after 3 (or more) episodes of CDI. Subjects, who will have been treated with at least a 10 day course of anti-CDI therapy (metronidazole, vancomycin or fidaxomicin) for the most recent acute infection, will then receive FMT with donor stool administered at the time of sigmoidoscopy. After the procedure, subjects will be followed for 8 weeks for C. difficile recurrence. Subjects who relapse during that period will be offered a repeat FMT using donor stool. We plan to collect baseline and post-FMT stool samples for microbiome analyses as well samples of urine and blood for metabolomic and immunologic studies. Subjects will be contacted at 24 weeks to assess long term safety outcomes
- Conditions
- Clostridium Difficile Infection
- 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 TransplantationBiological
Also called FMT, stool transplant
Fecal Microbiota Translantation involves administering fecal material from a healthy donor to a sick patient, with relapsing C-difficile infection, to restore missing components of normal intestinal flora. Subjects will receive Fecal Microbiota Translantation via sigmoidoscopy.
| Study group | Role | What they receive |
|---|---|---|
| Fecal Microbiota Translantation | No intervention | After completing at least 10 days course of antibiotic treatment for C. difficile infection, subjects will receive Fecal Microbiota transplantation with a 300 mL fecal suspension delivered via sigmoidoscopy. Receives: Biological: Fecal Microbiota Transplantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical cure
Measured: 8 weeks
Secondary outcomes (1)
Clinical failure
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2015 (estimated)
- Study startJun 2015
- Primary completionMar 2016 (estimated)
- Study completionMar 2017 (estimated)
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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Miriam Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Colleen Kelly, The Miriam Hospital
- Investigators
- Colleen Kelly, MD, Principal investigator, The Miriam Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02557685
- Sponsor's protocol ID
- 16216
- Status last verified
- Sep 2015
- First submitted
- 21 Sep 2015
- Last updated
- 23 Sep 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Alterations in Gut Microbiota and Metabolism Following FMT for Recurrent C. Difficile Infection
- ClinicalTrials.gov ID
- NCT02557685
- Acronym / sponsor ID
- 16216
- Conditions
- Clostridium Difficile Infection
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 6 participants (estimated)
- Lead sponsor
- The Miriam HospitalUniversity, hospital or other
- Study start
- Jun 2015
- Primary completion
- Mar 2016 (estimated)
- Study completion
- Mar 2017 (estimated)
- First posted
- 23 Sep 2015 (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.
This study aims to document early changes in the distal gut microbiota (both fecal and mucosa-associated) post FMT. Furthermore, whole blood and urine samples will facilitate collaborative immunologic and metabolomic analyses.
This will be an open label clinical trial of FMT to prevent further recurrence in patients who have suffered at least a third episode of Clostridium difficile infection (CDI) and who have previously been treated with oral vancomycin.
Detailed description
The exact mechanism by which FMT is effective is presently unknown. A recent study of 14 patients with recurrent CDI treated with FMT35 showed decreased diversity pre-FMT with gut microbiota becoming more diverse and similar to donors post-FMT. This group showed significant changes in 3 taxonomic orders but no single organism or species was universally associated with success. Weingarden et al. showed that FMT restored normal bile acid composition in patients with recurrent CDI36, suggesting that correction of bile acid metabolism is likely a major mechanism by which FMT results in a cure and prevents recurrence of CDI. Understanding mechanisms of FMT more completely may enable development of synthetic microbiota-based therapeutics which would be a safe and effective alternative to traditional FMT. We hypothesize that early changes in distal gut microbiota post-FMT may help identify key species associated with efficacy. Furthermore, we believe there are measurable metabolic and immunologic effects which may also be beneficial after FMT. This study aims to document early changes in the distal gut microbiota (both fecal and mucosa-associated) post FMT. Furthermore, whole blood and urine samples will facilitate collaborative immunologic and metabolomic analyses.
This will be an open label clinical trial of FMT to prevent further recurrence in patients who have suffered at least a third episode of Clostridium difficile infection (CDI) and who have previously been treated with oral vancomycin. Subjects will consist of 6 adult outpatients referred after 3 (or more) episodes of CDI. Subjects, who will have been treated with at least a 10 day course of anti-CDI therapy (metronidazole, vancomycin or fidaxomicin) for the most recent acute infection, will then receive FMT with donor stool administered at the time of sigmoidoscopy. After the procedure, subjects will be followed for 8 weeks for C. difficile recurrence. Subjects who relapse during that period will be offered a repeat FMT using donor stool. We plan to collect baseline and post-FMT stool samples for microbiome analyses as well samples of urine and blood for metabolomic and immunologic studies. Subjects will be contacted at 24 weeks to assess long term safety outcomes
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 Translantation | No intervention | Biological: Fecal Microbiota TransplantationAfter completing at least 10 days course of antibiotic treatment for C. difficile infection, subjects will receive Fecal Microbiota transplantation with a 300 mL fecal suspension delivered via sigmoidoscopy. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adult outpatients (age ≥18 and ≤90) referred to Dr. Kelly after suffering a third (or further) documented episode CDI and 2) who have failed to maintain CDI cure after standard therapy.
Key exclusion criteria (19 listed)
- • Patients who are pregnant
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 TransplantationAlso: FMT, stool transplantFecal Microbiota Translantation involves administering fecal material from a healthy donor to a sick patient, with relapsing C-difficile infection, to restore missing components of normal intestinal flora. Subjects will receive Fecal Microbiota Translantation via sigmoidoscopy. | Biological | Fecal Microbiota Translantation |
Primary outcome
Clinical cure
Time frame: 8 weeks
1 secondary outcome
Clinical failure
Time frame: 8 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2015.
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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.
Colleen Kelly, MD principal investigator
The Miriam Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Fecal Microbiota Transplantation in people with Clostridium Difficile Infection, run by The Miriam 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 3 inclusion and 19 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: status not confirmed, as of the sponsor's last update on 23 Sep 2015. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Colleen Kelly, MD (401-793-7396, ckelly2@lifespan.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical cure (time frame: 8 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 23 Sep 2015.