Lactobacillus Rhamnosus GG in Reducing Incidence of Graft-Versus-Host Disease in Patients Who Have Undergone Donor Stem Cell Transplant

Completed · Not applicable

Conditions studied: Graft Versus Host Disease

In brief

This randomized pilot clinical trial studies Lactobacillus rhamnosus GG in reducing incidence of graft-versus-host disease in patients who have undergone donor stem cell transplant. Lactobacillus rhamnosus GG may be effective at preventing for graft-versus-host disease caused by a donor stem cell transplant.

Key facts

Study ID

NCT02144701

Run by

Rutgers, The State University of New Jersey

People needed

33

Starts

2013-02-18

Expected to finish

2018-02-28

Last updated by the study team

2021-04-27

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Able to sign informed consent
• Undergoing allogeneic HSCT from a related or unrelated donor
• Hematopoietic engraftment as evidenced by recovery of the absolute neutrophil count to greater than 500/mm\^3 for > 3 days without filgrastim (G-CSF) support and within 40 days of transplant (i.e. complete blood counts [CBCs] obtained 3 or more days apart while off of G-CSF must demonstrate an absolute neutrophil count > 500/mm\^3); if absolute neutropenia is not achieved due to a non-myeloablative transplant, the patient can be enrolled on day +21 to +40
• Eastern Cooperative Oncology Group (ECOG) performance status of 0-2

You may not qualify if…

• Evidence of GVHD at the time of enrollment as assessed clinically
• Serum creatinine greater than 3.0
• Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) greater than 3 times the upper limit of normal
• Total bilirubin greater than 2 times upper limit of normal
• Prior use of probiotics within 3 months prior to enrollment
• Inability to take medications by mouth
• Prior history of inflammatory bowel disease or other chronic diarrheal illness
• Prior history of hypersensitivity to milk proteins
• Active Clostridium difficile infection or on prophylactic or tapering antibiotics for Clostridium difficile infection

Where it is running

• Rutgers Cancer Institute of New Jersey — New Brunswick, New Jersey, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.