Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02733744
Other study ID # 16-023
Secondary ID
Status Completed
Phase Early Phase 1
First received March 30, 2016
Last updated December 20, 2017
Start date May 2016
Est. completion date December 2017

Study information

Verified date December 2017
Source Massachusetts General Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

The microbiome (spectrum of bacteria in a patient's gut) is thought to play a role in helping to shape one's immune system given its direct contact with normal cells in our intestine. Recent studies have suggested that a microbiome with very few bacteria (low diversity) seems to be bad for health and a high-diversity microbiome (many different species) appears to be good. This appears to be true even for patients after HSCT where low diversity microbiome status has correlated with infections, GVHD and overall survival.

Fecal microbiota transplantation (FMT) is routinely performed for an infection caused by Clostridium difficile but is not yet approved by the FDA as a treatment for any disease. FMT restores a high diversity microbiome. It is hoped that through FMT, overall outcomes after HSCT can potentially be improved.

FMT will be performed in the first 3 weeks after recovery of white blood cells after HSCT. The source of FMT will be from healthy 3rd party donors. FMT will be performed through the ingestion of 30 capsules over 2 consecutive days.


Recruitment information / eligibility

Status Completed
Enrollment 18
Est. completion date December 2017
Est. primary completion date December 2016
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria:

- 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.

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.

- 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)

Study Design


Related Conditions & MeSH terms


Intervention

Biological:
Fecal Microbiota Transplantation (FMT)
FMT will be given through the ingestion of 30 capsules (15 capsules daily x 2 consecutive days)

Locations

Country Name City State
United States Massachusetts general Hospital Boston Massachusetts

Sponsors (1)

Lead Sponsor Collaborator
Massachusetts General Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Progression Free Survival 2 years
Secondary Overall Survival 2 years
Secondary Cumulative Incidence Of aGVHD 2 years
Secondary Non-Relapse Mortality Rate 2 years
Secondary Number of participants with treatment-related adverse events Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 1 year
See also
  Status Clinical Trial Phase
Recruiting NCT06148610 - Evaluation of the Impact of the Use of NewSpringForMe on Transplanted Patients' Quality of Life and Support
Completed NCT02212236 - Psychological Intervention for Distress During HSCT Phase 2
Completed NCT00023530 - Blood and Marrow Transplant Clinical Research Network N/A
Completed NCT01466335 - An Adaptive Phase I Study to Evaluate the Safety, Efficacy and Dose Responses of Ronacaleret in Healthy Human Volunteers Phase 1
Withdrawn NCT02682953 - Hyperbaric Oxygen Therapy for Hematopoietic Progenitor Cell Collection in Poor Mobilizers Phase 2
Completed NCT00775632 - Alemtuzumab and Cyclosporine for the Prevention of Graft vs Host Disease After Stem Cell Transplants Phase 2
Completed NCT00048256 - Relationship Between Personality and Coping Styles in Bone Marrow Transplant Candidates N/A
Completed NCT00004994 - Comparison of Quality of Life in Patients Undergoing More Intensive Versus Less Intensive Chemotherapy and Radiation Preceding a Bone Marrow Transplant N/A
Completed NCT04039100 - Family Caregiver Ambassador Support for Family Caregivers of Patients With Hematological Disease N/A
Completed NCT04535570 - Evolution of the Energy Expenditure During Hematopoietic Stem Cell Transplantation
Recruiting NCT06118853 - Impact of Yoga and Gentle Massage Practices on Symptom Management in Patients Undergoing HSCT N/A
Active, not recruiting NCT01016093 - Zoledronic Acid for the Prevention of Bone Loss Post-bone Marrow Transplantation for Thalassemia Major Patients Phase 2/Phase 3
Completed NCT01015183 - Prevention Chemotherapy Induced Mucositis by Zinc Sulfate Phase 2/Phase 3
Completed NCT00843180 - Massage for Pediatric Oncology N/A
Completed NCT00000591 - T-Cell Depletion in Unrelated Donor Marrow Transplantation Phase 3
Completed NCT04474730 - Physical Activity Monitoring Among BMT Patients N/A
Active, not recruiting NCT02319226 - Toward Immune Biomarkers for Tolerance and GvHD in Humans
Recruiting NCT00673348 - Therapeutic Drug Monitoring (TDM) of Voriconazole and Correlation With CYP2C19 Genotype in Korean Populations N/A
Completed NCT00005556 - Retention of Bone Marrow Donors in a National Registry N/A
Completed NCT05391347 - Effects of Orange Oil Aromatherapy on the Pain and Anxiety N/A