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CompletedNCT02144701Updated Apr 27, 2021Results posted

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

An interventional study of Lactobacillus rhamnosus GG and laboratory biomarker analysis was not performed because of no differences in the clinical outcomes in Graft Versus Host Disease, sponsored by Rutgers, The State University of New Jersey. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-04-27.

Sponsored by Rutgers, The State University of New Jersey · Not applicable, Interventional, and Supportive care

From the registry’s dates

  • Registered 1 year 3 months after the study started (first participant enrolled Feb 2013, registered May 2014).
Phase
Not applicable
Study type
Interventional
Enrollment
33
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the detailed description

PRIMARY OBJECTIVES:

I. To determine if hematopoietic stem cell transplant (HSCT) patients treated with a probiotic (Lactobacillus GG [Lactobacillus rhamnosus GG])-containing diet compared to those not assigned to receive probiotic have a lower incidence of grade 1 upper gastrointestinal (GI) or grade 2-4 lower GI acute graft-versus-host disease (GVHD) (aGVHD) using Center for International Blood and Marrow Transplant Research (CIBMTR) scoring than those not prescribed a probiotic.

II. To determine if HSCT patients treated with a probiotic-containing diet compared to those not assigned to receive a probiotic have a: a) lower rate of organ-specific acute aGVHD (intestinal tract, skin, liver); b) lower rate of moderate or severe chronic GVHD (National Institutes of Health [NIH] consensus scoring) at 6 months and 1 year post transplant; c) shorter duration of immunosuppressive therapy (normalized for age and degree of human leukocyte antigen [HLA] match); d) lower rate of bacterial and/or opportunistic infection.

SECONDARY OBJECTIVES:

I. To determine if allogeneic hematopoietic stem cell patients treated with a probiotic compared to those not assigned to receive a probiotic have differences in: a) composition and proportion of the major gut bacterial phylotypes in stool (to be analyzed for changes pre- and post-initiation of probiotics and for association with development of aGVHD); b) measures of inflammation as assessed by cytokine or receptor production (interleukin [IL]-6, IL-8, tumor necrosis factor [TNF]-alpha, TNF-receptor 1, interferon-gamma, IL-2R, IL-10); c) qualitative measures of immune reconstitution as determined by sequential measurements of conventional T cells, regulatory T regulatory, B cells and natural killer (NK) cells; d) antibody class/subclass production; e) biomarkers associated with GVHD-elafin, regenerating islet-derived 3 alpha (Reg3a), suppressor of tumorigenicity-2 (ST2), hepatocyte growth factor (HGF); and/or urinary tryptophan metabolites; f) markers of gut barrier function including blood levels of endotoxin and microbial deoxyribonucleic acid (DNA).

OUTLINE: Patients are randomized to 1 of 2 treatment arms.

ARM I: Patients receive Lactobacillus rhamnosus GG orally (PO) once daily (QD) for 1 year.

ARM II: Patients receive no intervention.

02

Conditions studied

  • Graft Versus Host Disease

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03

In context

Graft vs Host Disease

806 studies on the registry are indexed under Graft vs Host Disease; 138 are open to participants now.

This study's enrollment of 33 is close to the median of 35 across 637 interventional studies indexed under Graft vs Host Disease.

Browse Graft vs Host Disease studies →

Lead sponsor

Rutgers, The State University of New Jersey is the lead sponsor of 496 studies on the registry; 130 are open to participants now.

Of its 38 completed or terminated interventional studies of FDA-regulated products, 30 (79%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
33 participants (actual)

Study arms

  • Experimental
    Lactobacillus rhamnosus GG

    Patients receive Lactobacillus rhamnosus GG PO QD for 1 year.

    Dietary Supplement: Lactobacillus rhamnosus GG · Other: laboratory biomarker analysis was not performed because of no differences in the clinical outcomes

  • No intervention
    No intervention

    Patients receive no intervention.

Interventions

  • Dietary supplementLactobacillus rhamnosus GG

    Given PO

    Also known as: Culturelle, Gefilus, LGG

  • Otherlaboratory biomarker analysis was not performed because of no differences in the clinical outcomes

    Correlative studies

06

What researchers measure

Primary outcomes

  1. Rate of Grade 1 Upper GI and/or 2-4 Lower GI aGVHD Assessed Using CIBMTR Scoring

    Time frame: Baseline

  2. Rate of Grade 1 Upper GI and/or 2-4 Lower GI aGVHD Assessed Using CIBMTR Scoring

    Time frame: 1 month

  3. Rate of Grade 1 Upper GI and/or 2-4 Lower GI aGVHD Assessed Using CIBMTR Scoring

    Time frame: 3 months

  4. Rate of Grade 1 Upper GI and/or 2-4 Lower GI aGVHD Assessed Using CIBMTR Scoring

    Time frame: 6 months

  5. Rate of Grade 1 Upper GI and/or 2-4 Lower GI aGVHD Assessed Using CIBMTR Scoring

    Time frame: 9 months

  6. Rate of Grade 1 Upper GI and/or 2-4 Lower GI aGVHD Assessed Using CIBMTR Scoring

    Time frame: 12 months

07

Results

Posted Nov 16, 2018

Participant flow

Subjects were recruited through the Rutgers Cancer Institute of New Jersey. The study was open to accrual on 02/18/2013 and was closed to accrual on 04/22/2016.

Participant flow — Overall Study
MilestoneLactobacillus Rhamnosus GGno Intervention
Started2211
Completed138
Not completed93
Withdrew: Development of relapse, gvhd or death93

Outcome measures

PrimaryRate of Grade 1 Upper GI and/or 2-4 Lower GI aGVHD Assessed Using CIBMTR Scoring
Time frame:
Baseline
Reported as:
Count of participants · Participants
Rate of Grade 1 Upper GI and/or 2-4 Lower GI aGVHD Assessed Using CIBMTR Scoring
ParticipantsArm I (Lactobacillus Rhamnosus GG)Arm II (no Intervention)
Rate of Grade 1 Upper GI and/or 2-4 Lower GI aGVHD Assessed Using CIBMTR Scoring104
PrimaryRate of Grade 1 Upper GI and/or 2-4 Lower GI aGVHD Assessed Using CIBMTR Scoring
Time frame:
1 month
Reported as:
Count of participants · Participants
Rate of Grade 1 Upper GI and/or 2-4 Lower GI aGVHD Assessed Using CIBMTR Scoring
ParticipantsArm I (Lactobacillus Rhamnosus GG)Arm II (no Intervention)
Rate of Grade 1 Upper GI and/or 2-4 Lower GI aGVHD Assessed Using CIBMTR Scoring104
PrimaryRate of Grade 1 Upper GI and/or 2-4 Lower GI aGVHD Assessed Using CIBMTR Scoring
Time frame:
3 months
Reported as:
Count of participants · Participants
Rate of Grade 1 Upper GI and/or 2-4 Lower GI aGVHD Assessed Using CIBMTR Scoring
ParticipantsArm I (Lactobacillus Rhamnosus GG)Arm II (no Intervention)
Rate of Grade 1 Upper GI and/or 2-4 Lower GI aGVHD Assessed Using CIBMTR Scoring104
PrimaryRate of Grade 1 Upper GI and/or 2-4 Lower GI aGVHD Assessed Using CIBMTR Scoring
Time frame:
6 months
Reported as:
Count of participants · Participants
Rate of Grade 1 Upper GI and/or 2-4 Lower GI aGVHD Assessed Using CIBMTR Scoring
ParticipantsArm I (Lactobacillus Rhamnosus GG)Arm II (no Intervention)
Rate of Grade 1 Upper GI and/or 2-4 Lower GI aGVHD Assessed Using CIBMTR Scoring104
PrimaryRate of Grade 1 Upper GI and/or 2-4 Lower GI aGVHD Assessed Using CIBMTR Scoring
Time frame:
9 months
Reported as:
Count of participants · Participants
Rate of Grade 1 Upper GI and/or 2-4 Lower GI aGVHD Assessed Using CIBMTR Scoring
ParticipantsArm I (Lactobacillus Rhamnosus GG)Arm II (no Intervention)
Rate of Grade 1 Upper GI and/or 2-4 Lower GI aGVHD Assessed Using CIBMTR Scoring104
PrimaryRate of Grade 1 Upper GI and/or 2-4 Lower GI aGVHD Assessed Using CIBMTR Scoring
Time frame:
12 months
Reported as:
Count of participants · Participants
Rate of Grade 1 Upper GI and/or 2-4 Lower GI aGVHD Assessed Using CIBMTR Scoring
ParticipantsArm I (Lactobacillus Rhamnosus GG)Arm II (no Intervention)
Rate of Grade 1 Upper GI and/or 2-4 Lower GI aGVHD Assessed Using CIBMTR Scoring104

Adverse events

Collected over Adverse events were collected over a period of one year.. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Arm I (Lactobacillus Rhamnosus GG)4/21 (19%)0/21 (0%)0/21 (0%)
Arm II (no Intervention)1/10 (10%)0/10 (0%)0/10 (0%)

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)Arm I (Lactobacillus Rhamnosus GG)Arm II (no Intervention)Total
<=18 years000
Between 18 and 65 years19726
>=65 years235
Sex: Female, Male
Sex: Female, Male(Participants)Arm I (Lactobacillus Rhamnosus GG)Arm II (no Intervention)Total
Female12315
Male9716
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)Arm I (Lactobacillus Rhamnosus GG)Arm II (no Intervention)Total
Hispanic or Latino325
Not Hispanic or Latino18826
Unknown or Not Reported000
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Arm I (Lactobacillus Rhamnosus GG)Arm II (no Intervention)Total
American Indian or Alaska Native000
Asian000
Native Hawaiian or Other Pacific Islander000
Black or African American314
White16824
More than one race000
Unknown or Not Reported213
Region of Enrollment
Region of Enrollment(participants)Arm I (Lactobacillus Rhamnosus GG)Arm II (no Intervention)Total
United States211031
08

Study locations

1 site
  • Rutgers Cancer Institute of New Jersey
    New Brunswick, New Jersey 08903, United States
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 27, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02144701
Lead sponsor
Rutgers, The State University of New Jersey
Collaborators
Rutgers Cancer Institute of New Jersey, National Cancer Institute (NCI)
Responsible party
Roger Strair, MD, PhD (Professor of Medicine, RWJMS, Rutgers Cancer Institute of New Jersey) — Principal investigator
First posted
May 22, 2014
Start date
Feb 18, 2013
Primary completion
Feb 28, 2016
Completion
Feb 28, 2018
Results posted
Nov 16, 2018
Last update
Apr 27, 2021

Study contacts

Roger Strair
principal investigator · Rutgers Cancer Institute of New Jersey

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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