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Trial record 6 of 22 for:    capsule | Recruiting Studies | fecal microbiota transplantation

Fecal Microbiota Transplantation (FMT) in Recipients After Allogeneic Hematopoietic Cell Transplantation (HCT)

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ClinicalTrials.gov Identifier: NCT03720392
Recruitment Status : Recruiting
First Posted : October 25, 2018
Last Update Posted : January 18, 2019
Sponsor:
Collaborator:
Sundry Funding
Information provided by (Responsible Party):
Zachariah Michael DeFilipp, Massachusetts General Hospital

Tracking Information
First Submitted Date  ICMJE October 24, 2018
First Posted Date  ICMJE October 25, 2018
Last Update Posted Date January 18, 2019
Actual Study Start Date  ICMJE January 15, 2019
Estimated Primary Completion Date November 30, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 24, 2018)
The proportion of patients who achieve gut microbiome diversity at one month following the final post-HCT FMT [ Time Frame: 1 Month ]
Gut microbiome diversity will be assessed using urinary 3-indoxyl sulfate (3-IS) levels, with 35 umol/mmol creatinine as the cutoff (≥ 35: diverse; < 35: not diverse).
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03720392 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: October 24, 2018)
  • Cumulative Incidence of Acute Graft-Versus-Host-Disease (GvHD) [ Time Frame: 6 months ]
    The cumulative incidence of overall grades II-IV and grades III-IV acute GVHD will be assessed through six months after last dose of FMT or placebo. Acute GVHD will be assessed using the Mount Sinai Acute GVHD International Consortium (MAGIC) criteria.
  • Cumulative Incidence of non-relapse-mortality [ Time Frame: 6 Months,12 Months ]
    Non-relapse mortality (NRM) is defined as the time from first dose of FMT or placebo to death without relapse or progression or underlying disease.
  • Cumulative incidence of infection at 100 days [ Time Frame: 100 Days ]
  • Progression Free Survival [ Time Frame: 6 Months, 12 Months ]
    Progression-Free Survival (PFS) is defined as the time from first dose of FMT or placebo to the earlier of underlying disease progression or death due to any cause.
  • Overall Survival [ Time Frame: 6 Months, 12 Months ]
    Overall survival is measured as the amount of time from the first dose of Fecal Microbiota Transplantation (FMT) or placebo to death due to any cause.
  • Graft Versus Host Disease(GVHD)/ Relapse Free Survival (GRFS) [ Time Frame: 12 Months ]
    GVHD-Free/Relapse-Free Survival (GRFS) is defined as the time from first dose of FMT or placebo to the earlier of diagnosis of GVHD or disease progression or relapse.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Fecal Microbiota Transplantation (FMT) in Recipients After Allogeneic Hematopoietic Cell Transplantation (HCT)
Official Title  ICMJE A Phase 2 Study of Fecal Microbiota Transplantation (FMT) in Recipients After Allogeneic Hematopoietic Cell Transplantation (HCT)
Brief Summary This research study is studying the role fecal microbiota transplantation may play in post-Hematopoietic Cell Transplantation (HCT) recipients
Detailed Description

This research study is a Phase II clinical trial. Phase II clinical trials test the safety and effectiveness of an investigational intervention to learn whether the intervention works in treating a specific disease. "Investigational" means that the intervention is being studied.

The FDA (the U.S. Food and Drug Administration) has not approved FMT for this use.

After HCT, the body's microbiome (the natural existence of various bacteria and organisms) in the intestinal tract may be affected, in that the number and types of good bacteria is reduced (also called a reduction in microbial flora diversity). Studies have shown that the number and types of good bacteria in the gut can impact whether or not a person develop a disease called graft-versus-host disease (GVHD). GVHD occurs when donated bone marrow cells attack the body with an immune response. Researchers believe that more microbial flora diversity in the gut is linked to a lower risk of developing GVHD.

FMT is a process utilizing microbial components which are the good, healthy bacteria that would otherwise naturally occur in the body. Since the participant may have decreased microbial flora diversity after HCT, these microbial components are taken from a 3rd party donor. They are extracted from fecal matter (stool) and put into a capsule which the participant then ingest.

Researchers believe that FMT administration may play a role in restoring higher microbial flora diversity in the gut. Therefore, FMT administration may play a role in decreasing the likelihood of developing GVHD.

In this research study, the investigators are...

  • Examining the microbial flora diversity of your gut after FMT administration
  • Looking for incidence rate of GVHD and other post-HCT complications
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Allogeneic Hematopoietic Cell Transplantation (HCT)
Intervention  ICMJE
  • Drug: FMT
    FMT is a process utilizing microbial components which are the good, healthy bacteria that would otherwise naturally occur in the body.
  • Drug: Placebo
    a harmless pill, medicine, or procedure prescribed more for the psychological benefit to the patient than for any physiological effect.
Study Arms  ICMJE
  • Experimental: FMT Capsules
    • Two doses of FMT: one standard dose starting within four (4) days from the start of the conditioning regimen prior to HCT and one non-standard dose starting within 4 weeks after engraftment after HCT.
    • A standard dose of oral FMT is 15 capsules per day for two consecutive days,
    Intervention: Drug: FMT
  • Placebo Comparator: Placebo Capsules
    • Two doses of placebo, instead of FMT: one starting within four (4) days from the start of the conditioning regimen prior to HCT and the second one starting within 4 weeks after engraftment after HCT.
    • A standard dose of oral Placebo is 15 capsules per day for two consecutive days,
    Intervention: Drug: Placebo
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: October 24, 2018)
48
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE November 30, 2021
Estimated Primary Completion Date November 30, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Men or women ≥ 18 and ≤ 80 years old
  • Patients designated to undergo myeloablative or intermediate intensity allogeneic peripheral blood or bone marrow hematopoietic cell transplantation. Consent will be obtained prior to admission for HSCT. Patients receiving any donor source of stem cells are eligible. Eligible conditioning regimens are those defined as myeloablative by the ASBMT Consensus Criteria (Bacigalupo 2009) as well as the combination of fludarabine with melphalan (100-140 mg/mg2)
  • Any GVHD prophylaxis regimen is allowed.
  • ECOG performance status ≤ 2 (Karnofsky ≥ 60%, see Appendix A)
  • Patients with adequate physical function as measured by

    • Cardiac: Left ventricular ejection fraction at rest must be ≥ 40%, or shortening fraction >25%
    • Hepatic:
    • Bilirubin ≤ 2.5 mg/dL, except for patients with Gilbert's syndrome or hemolysis
    • ALT, AST, and Alkaline Phosphatase < 5 x ULN
    • Renal: Serum creatinine within normal range, or if serum creatinine is outside normal range, then renal function (measured or estimated creatinine clearance or GFR) ≥ 40mL/min/1.73m2
    • Pulmonary: DLCO (corrected for hemoglobin), FEV1 and FVC ≥ 50% predicted
  • Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. Women of childbearing potential will have a urine pregnancy test, which must be negative, on Study Day 1, prior to receiving FMT. Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study and for 3 months after FMT.
  • Ability to understand and the willingness to sign a written informed consent document, including the willingness to accept risk of unrelated donor stool.
  • Ability to swallow large capsules.

Exclusion Criteria:

  • Prior allogeneic hematopoietic stem cell transplantation. (Patients may have received a prior autologous hematopoietic stem cell transplant.)
  • Participants who are receiving any other investigational agents.
  • Uncontrolled intercurrent illness including, but not limited to, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
  • Patients with active or uncontrolled bacterial, viral, or fungal infection(s) requiring systemic therapy.
  • Planned use of prophylactic donor lymphocyte infusion (DLI) therapy.
  • Delayed gastric emptying syndrome or large hiatal hernia
  • Known chronic aspiration
  • Participants with a history of significant allergy to foods not excluded from the donor diet (excluded foods are tree nuts, peanuts, shellfish, eggs)
  • Pregnant and breast-feeding women are ineligible because they are not eligible for hematopoietic stem cell transplantation.
  • HIV-positive participants are ineligible.
  • Participants who are unable to swallow pills.
  • Participants with end-stage liver disease (cirrhosis)
  • Participants with acute, active gastrointestinal infection (e.g., typhlitis, diverticulitis, appendicitis)
  • Participants with inflammatory bowel disease (e.g., ulcerative colitis, Crohn's)
  • Prior total colectomy
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Zachariah DeFilipp, MD 617-724-4000 zdefilipp@mgh.harvard.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03720392
Other Study ID Numbers  ICMJE 18-293
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Zachariah Michael DeFilipp, Massachusetts General Hospital
Study Sponsor  ICMJE Zachariah Michael DeFilipp
Collaborators  ICMJE Sundry Funding
Investigators  ICMJE
Principal Investigator: zachariah DeFilipp, MD Massachusetts General Hospital
PRS Account Massachusetts General Hospital
Verification Date January 2019

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