Fecal Microbiota Transplantation (FMT) in Recipients After Allogeneic Hematopoietic Cell Transplantation (HCT)
Fecal Microbiota Transplantation (FMT) in Recipients After Allogeneic Hematopoietic Cell Transplantation (HCT)
This research study is studying the role fecal microbiota transplantation may play in
 post-Hematopoietic Cell Transplantation (HCT) recipients
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
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