Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 3:58 PM
Ignite Modification Date:
2025-12-24 @ 3:58 PM
NCT ID:
NCT03720392
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT03720392
Study Brief:
Protocol Section:
NCT03720392