Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 3 of 89 for:    Recruiting Studies | fecal microbiota transplantation

Fecal Microbiota Transplantation for Steroid Resistant and Steroid Dependent Gut Acute Graft Versus Host Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03214289
Recruitment Status : Recruiting
First Posted : July 11, 2017
Last Update Posted : April 9, 2018
Sponsor:
Information provided by (Responsible Party):
Dr. Shouval Roni, Sheba Medical Center

Tracking Information
First Submitted Date  ICMJE June 29, 2017
First Posted Date  ICMJE July 11, 2017
Last Update Posted Date April 9, 2018
Actual Study Start Date  ICMJE July 12, 2017
Estimated Primary Completion Date July 20, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 10, 2017)
Serious adverse events [ Time Frame: 28 days following FMT. ]
Participants will be evaluated for serious adverse events (SAEs) relating to FMT occurring within 28 days following transplantation. SAEs are defined as any adverse experience occurring during or after FMT that results in any of the following outcomes: death, life-threatening experience, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity or an important medical event events
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03214289 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: April 5, 2018)
  • Non-serious adverse events [ Time Frame: 28 days following FMT. ]
    Participants will be evaluated for non-serious adverse events relating to FMT within 28 days following transplantation. Non-serious adverse events are defined as diarrhea, nausea and vomiting, fatigue and malaise, headache, and distension/bloating/abdominal discomfort/pain
  • Gut acute Graft-versus-Host Disease (aGvHD) response. [ Time Frame: up to 28 days following FMT. ]
    Participants will be evaluated on days 7 and 28 following transplantation for response to therapy. Response criteria for steroid-resistant patients is as follows:
    • Complete response: resolution of all gastrointestinal signs and symptoms
    • Partial response: decrease in severity of gut GVHD by at least one stage
    • Progression: Progressive worsening of gut GVHD
    • No change: No significant change in gut GVHD
    Response criteria for steroid-dependent patients is as follows:
    • Complete response: reduction of the steroid dose to 5 mg or less of prednisone (or a steroid equivalent) per day.
    • Partial response: a reduction of ≥40% in the dose of steroid
    • Progression: an increase of >=10% in the steroid dose
    • No change: any other option
  • aGvHD severity [ Time Frame: up to 28 days following FMT. ]
    Participants will be evaluated on days 7 and 28 following transplantation for severity of aGvHD. aGVHD severity is graded by the International Bone Marrow Transplant Registry Severity Index grading system
  • Reduction in the dose of steroids. [ Time Frame: up to 28 days following FMT. ]
    The dose of methylprednisolone, or an equivalent GCS, will be evaluated on day 7, and 28. The change in the dose at day 28, adjusted to the type of GCS used.
Original Secondary Outcome Measures  ICMJE
 (submitted: July 10, 2017)
  • Non-serious adverse events [ Time Frame: 28 days following FMT. ]
    Participants will be evaluated for non-serious adverse events relating to FMT within 28 days following transplantation. Non-serious adverse events are defined as diarrhea, nausea and vomiting, fatigue and malaise, headache, and distension/bloating/abdominal discomfort/pain
  • Gut acute Graft-versus-Host Disease (aGvHD) response. [ Time Frame: up to 28 days following FMT. ]
    Participants will be evaluated on days 7 and 28 following transplantation for response to therapy. Response criteria for steroid-resistant patients is as follows:
    • Complete response: resolution of all gastrointestinal signs and symptoms
    • Partial response: decrease in severity of gut GVHD by at least one stage
    • Progression: Progressive worsening of gut GVHD
    • No change: No significant change in gut GVHD
    Response criteria for steroid-dependent patients is as follows:
    • Complete response: reduction of the steroid dose to 5 mg or less of prednisone (or a steroid equivalent) per day.
    • Partial response: a reduction of ≥40% in the dose of steroid
    • Progression: an increase of >=10% in the steroid dose
    • No change: any other option
  • aGvHD severity [ Time Frame: up to 28 days following FMT. ]
    Participants will be evaluated on days 7 and 28 following transplantation for severity of aGvHD. aGVHD severity is graded by the International Bone Marrow Transplant Registry Severity Index grading system
  • Reduction in the dose of steroids. [ Time Frame: up to 28 days following FMT. ]
    The dose of methylprednisolone, or an equivalent GCS, will be evaluated on day 7, and 28. The change in the dose at day 28, adjusted to the type of GCS used.
  • Change in biomarkers. [ Time Frame: up to 28 days following FMT. ]
    Change in levels of albumin and C-reactive protein between days 0 and days 28 will serve as a secondary endpoint.
  • Quality of Life. [ Time Frame: up to 180 days following FMT. ]
    Participants quality of life will be measured using a standardized quality of life questionnaire (EORTC QLQ-C30) prior to transplantation and on days 7, 14, 21, 28 and 180 following transplantation.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Fecal Microbiota Transplantation for Steroid Resistant and Steroid Dependent Gut Acute Graft Versus Host Disease
Official Title  ICMJE Fecal Microbiota Transplantation for Treatment of Steroid Resistant and Steroid Dependent Gut Acute Graft Versus Host Disease- a Pilot Study
Brief Summary

The investigators hypothesize that perturbations in the intestinal microbiota following allogeneic hematopoietic stem cell transplantation (HSCT) are essential for the development and propagation of acute graft-versus-host disease. Therefore, modification of HSCT recipients' gut microbiota using fecal transplantation from a healthy donor could be used to treat gut acute GVHD.

The study evaluates safety and feasibility of fecal microbiota transplantation with frozen capsules from healthy donors for the treatment of steroid resistant or steroid dependent acute graft-versus-host disease of the gut.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Stem Cell Transplant Complications
  • Graft Versus Host Disease, Acute
  • Fecal Microbiota Transplantation
Intervention  ICMJE Biological: Fecal Microbiota Transplantation
Thirty fecal microbiota capsules produced from a single healthy donor, unrelated to the participant.
Study Arms  ICMJE Experimental: Fecal Microbiota Transplantation (FMT)

Participants will receive a single dose of oral FMT, which is 15 capsules per day for 2 consecutive days (total of 30 capsules). All capsules administered to a participant are from the same unrelated donor. Participants will be asked to fast for 4 hours prior to and 1 hour following capsule intake. Participants will be asked to drink at least 360cc of water during administration.

Treatment will be administered on an inpatient basis. In patients with no/partial response, the FMT may be repeated from the same or a different donor.

Subjects receiving any amount of the FMT capsules will be followed for at least 6 months.Stool and blood samples will be serially collected.

Intervention: Biological: Fecal Microbiota Transplantation
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: July 10, 2017)
4
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 20, 2019
Estimated Primary Completion Date July 20, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Adults (ages 18 to 75 years) who underwent allogeneic hematopoietic stem cell transplantation (HSCT) and developed gut acute Graft-versus-Host Disease (aGvHD).
  • Participants have steroid-resistant or steroid-dependent gut aGvHD.
  • Steroid resistant gut aGvHD is defined as cases in which gastrointestinal symptoms do not improve within 7 days after initial steroid therapy (≥1 mg/kg of methylprednisolone) or clear progression after 5 days.)
  • Steroid-dependent gut aGVHD is defined as cases in which reduction of steroid dose was not possible due to exacerbation of gastrointestinal symptoms.
  • Participants may have undergone allogeneic HSCT for any diagnosis at any time prior to developing aGvHD, and are not restricted to any specific conditioning regimen or by the subsequent administration of donor lymphocyte infusion.
  • Participants should be able to give informed consent.

Exclusion Criteria:

  • Participants may not have gut aGvHD which permits the tapering of steroid dose.
  • Participants may not have ongoing, uncontrolled infection (i.e. unresolved bacteremia, uncontrolled CMV infection).
  • Participants may not have ongoing enteritis primarily caused by enteropathy other than gut GvHD, excluding resistant clostridium difficile infection.
  • Participants may not have acute neutrophil count < 500 cells/µL.
  • Participants may not have toxic megacolon
  • Participants may not have active gastrointestinal bleeding.
  • Participants may not be pregnant or lactating.
  • Participants may not be unable to swallow pills.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Roni Shouval, MD 972-3-5305830 roni.shoval@sheba.health.gov.il
Listed Location Countries  ICMJE Israel
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03214289
Other Study ID Numbers  ICMJE 3822-16-SMC
3822-16-SMC ( Other Identifier: Sheba Medical Center, Tel-HaShomer, Israel )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Dr. Shouval Roni, Sheba Medical Center
Study Sponsor  ICMJE Sheba Medical Center
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Roni Shouval, MD Sheba Medical Center
PRS Account Sheba Medical Center
Verification Date April 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP