Fecal Microbiota Transplantation (FMT) in Recipients After Allogeneic Hematopoietic Cell Transplantation (HCT)
Condition: Allogeneic Hematopoietic Cell Transplantation (HCT)
Intervention: FMT; Placebo
Intervention description: FMT is a process utilizing microbial components which are the good, healthy bacteria that would otherwise naturally occur in the body.; a harmless pill, medicine, or procedure prescribed more for the psychological benefit to the patient than for any physiological effect.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 8.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: Allogeneic Hematopoietic Cell Transplantation (HCT)

Summary:

      This research study is studying the role fecal microbiota transplantation may play in
      post-Hematopoietic Cell Transplantation (HCT) recipients
    

Eligibility criteria:

        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