NCT02557685

Brief 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. 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
6

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Jun 2015

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2015

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

September 21, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 23, 2015

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2016

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2017

Completed
Last Updated

September 23, 2015

Status Verified

September 1, 2015

Enrollment Period

9 months

First QC Date

September 21, 2015

Last Update Submit

September 21, 2015

Conditions

Clostridium Difficile Infection

Outcome Measures

Primary Outcomes (1)

  • Clinical cure

    8 weeks

Secondary Outcomes (1)

  • Clinical failure

    8 weeks

Study Arms (1)

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.

Biological: Fecal Microbiota Transplantation

Interventions

Fecal Microbiota TransplantationBIOLOGICAL

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.

Also known as: FMT, stool transplant
Fecal Microbiota Translantation

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • +4 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Miriam Hospital

Providence, Rhode Island, 02906, United States

RECRUITING

MeSH Terms

Conditions

Clostridium Infections

Interventions

Fecal Microbiota Transplantation

Condition Hierarchy (Ancestors)

Gram-Positive Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfections

Intervention Hierarchy (Ancestors)

Biological TherapyTherapeutics

Study Officials

  • Colleen Kelly, MD

    The Miriam Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Colleen Kelly, MD

CONTACT

401-793-7396ckelly2@lifespan.org

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Medical Doctor

Study Record Dates

First Submitted

September 21, 2015

First Posted

September 23, 2015

Study Start

June 1, 2015

Primary Completion

March 1, 2016

Study Completion

March 1, 2017

Last Updated

September 23, 2015

Record last verified: 2015-09

Locations

US(1)