Overview

Fecal Transplant +/- Gut Decontamination in Preventing Acute Graft Versus Host Disease in Patients Given Broad-Spectrum Antibiotics

Status:
Withdrawn
Trial end date:
2021-12-31
Target enrollment:
0
Participant gender:
All
Summary
This phase II trial studies how well a fecal microbiota transplant with or without total gut decontamination works in preventing graft versus host disease in patients exposed to broad-spectrum antibiotics. Fecal microbiota transplantation is the administration by enema of fecal matter (stool) that includes helpful bacteria from a normal, healthy donor. Total gut decontamination uses antibiotics to remove/reduce the amount of bacteria in the digestive system. It is not yet known if a fecal microbiota transplant with or without total gut decontamination works better in preventing graft versus host disease compared to standard immunosuppressive therapies (therapies that lower the normal function of the immune system).
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
M.D. Anderson Cancer Center
Collaborator:
National Cancer Institute (NCI)
Treatments:
Anti-Bacterial Agents
Nystatin
Piperacillin
Piperacillin, Tazobactam Drug Combination
Tazobactam
Criteria
Inclusion Criteria:

- Patients who are day -10 pre- to day +30 post-allogeneic hematopoietic cell transplant
(AHCT) from any donor or graft source and for any conditioning regimen

- Patients who have received treatment with meropenem or piperacillin-tazobactam
(pip-tazo) intravenously (IV) (of at least 24 hours duration) in past 7 days

- Controlled infection defined as hemodynamically stable and not requiring supplemental
oxygen of more than 2 liters via nasal cannula

- Patients who are able to take oral medications in suspension form

- Patients who are able to provide informed consent (IC) and comply with all study
visits and procedures

Exclusion Criteria:

- Patients who are anticipated to require continued broad spectrum antibiotics with
meropenem or pip-tazo IV for > 96 hours post-engraftment such as for known, documented
infections necessitating prolonged treatment

- Patients with a prior documented infection with mycormycetes

- Patients who are greater than 2 days from time of neutrophil engraftment post AHCT

- Patients with active enteric infections

- Patients with acute GVHD >= grade II

- Patients unwilling or unable to undergo the FMT via retention enema procedure

- Patients who have received treatment with an investigational agent within 2 weeks of
enrollment

- Patients unable to tolerate oral decontamination regimen of pip-tazo and nystatin due
to prior allergy or intolerance of these medications

- Patients with any medical or psychological condition that, in the opinion of the
investigator, might interfere with the subject's participation in the trial, pose any
additional risk for the subject, or confound the assessments of the subject