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Gut Microbiota Changes After Fecal Microbiota Transplantation

This study is currently recruiting participants.
See Contacts and Locations
Verified September 2015 by Colleen Kelly, The Miriam Hospital
Sponsor:
Information provided by (Responsible Party):
Colleen Kelly, The Miriam Hospital
ClinicalTrials.gov Identifier:
NCT02557685
First received: September 21, 2015
Last updated: NA
Last verified: September 2015
History: No changes posted
  Purpose

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.


Condition Intervention Phase
Clostridium Difficile Infection Biological: Fecal Microbiota Transplantation Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Alterations in Gut Microbiota and Metabolism Following FMT for Recurrent C. Difficile Infection

Resource links provided by NLM:


Further study details as provided by Colleen Kelly, The Miriam Hospital:

Primary Outcome Measures:
  • Clinical cure [ Time Frame: 8 weeks ]

Secondary Outcome Measures:
  • Clinical failure [ Time Frame: 8 weeks ]

Estimated Enrollment: 6
Study Start Date: June 2015
Estimated Study Completion Date: March 2017
Estimated Primary Completion Date: March 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Fecal Microbiota Translantation
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.
Biological: Fecal Microbiota Transplantation
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.
Other Name: FMT, stool transplant

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

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • • 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)
      • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02557685

Contacts
Contact: Colleen Kelly, MD 401-793-7396 ckelly2@lifespan.org

Locations
United States, Rhode Island
The Miriam Hospital Recruiting
Providence, Rhode Island, United States, 02906
Contact: Colleen R. Kelly, MD    401-793-7080    ckelly2@lifespan.org   
Contact: Patrizia Curran, MD    401-793-7824    pcurran1@lifespan.org   
Principal Investigator: Colleen R. Kelly, MD         
Sponsors and Collaborators
The Miriam Hospital
Investigators
Principal Investigator: Colleen Kelly, MD The Miriam Hospital
  More Information

Responsible Party: Colleen Kelly, Medical Doctor, The Miriam Hospital
ClinicalTrials.gov Identifier: NCT02557685     History of Changes
Other Study ID Numbers: 16216
Study First Received: September 21, 2015
Last Updated: September 21, 2015

Additional relevant MeSH terms:
Infection

ClinicalTrials.gov processed this record on July 21, 2017