N/A
Completed N=33
Lactobacillus Rhamnosus GG in Reducing Incidence of Graft-Versus-Host Disease in Patients Who Have Undergone Donor Stem Cell Transplant
Source: ClinicalTrials.gov NCT02144701 ↗Enrolled (actual)
33
Serious AEs
0.0%
Results posted
Nov 2018
Primary outcomePrimary: Rate of Grade 1 Upper GI and/or 2-4 Lower GI aGVHD Assessed Using CIBMTR Scoring — 10; 4 Participants
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Rate of Grade 1 Upper GI and/or 2-4 Lower GI aGVHD Assessed Using CIBMTR Scoring |
10; 4 | — |
Eligibility Criteria
Inclusion Criteria
- 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
Exclusion Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT02144701). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.