Fecal Microbiota Transplantation After HSCT

NCT02733744 | Completed Early Phase 1 DMC

• 1 other identifier: 16-023
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

This research study is studying an intervention called fecal microbiota transplantation (FMT). Patients who are scheduled to undergo Hematopoietic Stem Cell Transplantation are invited to take part in this clinical trial to undergo empiric FMT soon after hematopoietic engraftment. The primary endpoint will be to assess the feasibility of FMT in this population and to assess safety.

Conditions

Bone Marrow Transplantation

Keywords

Stem cell transplant; fecal microbiota transplantation

Outcome Measures

Primary Outcomes (1)

• Feasibility measured by number of participants able to ingest 15 FMT capsules over a 2-day period

  Number of participants able to ingest 15 FMT capsules over a 2 day period.

  2 days

Secondary Outcomes (5)

• Progression Free Survival

  2 years

• Overall Survival

  2 years

• Cumulative Incidence Of aGVHD

  2 years

• Non-Relapse Mortality Rate

  2 years

• Number of participants with treatment-related adverse events

  1 year

Study Arms (1)

Fecal Microbiota Transplant

EXPERIMENTAL

Each participant will undergo allogeneic hematopoietic stem cell transplantation, according to institutional standards. Participants will receive a single standard dose of oral Fecal Microbiota Transplantation (FMT), which is 15 capsules per day for two consecutive days, for a total of 30 capsules. Participants will be asked to fast for 4 hours prior to and 1 hour following capsule intake. Capsules will be individually handed to participants by a research nurse or physician. Each capsule will be taken with a sip of water.

Biological: Fecal Microbiota Transplantation (FMT)

Interventions

Fecal Microbiota Transplantation (FMT) BIOLOGICAL

FMT will be given through the ingestion of 30 capsules (15 capsules daily x 2 consecutive days)

Also known as: FMT

Fecal Microbiota Transplant

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men or women ≥ 18 and ≤ 65 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 Consensus Criteria (Bacigalupo 2009) as well as the combination of fludarabine with melphalan (100-140 mg/mg2)
• Any Graft-vs-Host disease (GVHD) prophylaxis regimen is allowed.
• Eastern Cooperative Oncology Group (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
• Alanine aminotransferase (ALT), aspartate aminotransferase (AST), and Alkaline Phosphatase \< 5 x Upper Limit of Institutional Normal Range (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) ≥ 40millileters/min/1.73m2.
• Pulmonary: Diffusing lung capacity for carbon monoxide (DLCO) (corrected for hemoglobin), Forced expiratory volume in 1 second (FEV1) and Forced vital capacity (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. 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 oral medications.

You may not qualify if:

• 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.
• Patients with history of primary idiopathic myelofibrosis or any severe marrow fibrosis.
• Planned use of prophylactic donor lymphocyte infusion (DLI) therapy.
• Delayed gastric emptying syndrome
• Known chronic aspiration
• Patients 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)

Sponsors & Collaborators

• Massachusetts General Hospital: lead

Study Sites (1)

Massachusetts general Hospital

Boston, Massachusetts, 02114, United States

Location

Related Publications (1)

• DeFilipp Z, Peled JU, Li S, Mahabamunuge J, Dagher Z, Slingerland AE, Del Rio C, Valles B, Kempner ME, Smith M, Brown J, Dey BR, El-Jawahri A, McAfee SL, Spitzer TR, Ballen KK, Sung AD, Dalton TE, Messina JA, Dettmer K, Liebisch G, Oefner P, Taur Y, Pamer EG, Holler E, Mansour MK, van den Brink MRM, Hohmann E, Jenq RR, Chen YB. Third-party fecal microbiota transplantation following allo-HCT reconstitutes microbiome diversity. Blood Adv. 2018 Apr 10;2(7):745-753. doi: 10.1182/bloodadvances.2018017731.

  PMID: 29592876 DERIVED

MeSH Terms

Interventions

Fecal Microbiota Transplantation

Intervention Hierarchy (Ancestors)

Biological Therapy; Therapeutics

Study Officials

• Yi-Bin Chen, MD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: March 30, 2016
• First Posted: April 11, 2016
• Study Start: May 1, 2016
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2017
• Last Updated: December 22, 2017

Record last verified: 2017-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)