NCT02144701

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
33

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2013

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 18, 2013

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

May 20, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 22, 2014

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2016

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2018

Completed
9 months until next milestone

Results Posted

Study results publicly available

November 16, 2018

Completed
Last Updated

April 27, 2021

Status Verified

April 1, 2021

Enrollment Period

3 years

First QC Date

May 20, 2014

Results QC Date

March 6, 2017

Last Update Submit

April 23, 2021

Conditions

Graft Versus Host Disease

Outcome Measures

Primary Outcomes (6)

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

    Baseline

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

    1 month

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

    3 months

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

    6 months

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

    9 months

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

    12 months

Study Arms (2)

Lactobacillus rhamnosus GG

EXPERIMENTAL

Patients receive Lactobacillus rhamnosus GG PO QD for 1 year.

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

No intervention

NO INTERVENTION

Patients receive no intervention.

Interventions

Lactobacillus rhamnosus GGDIETARY_SUPPLEMENT

Given PO

Also known as: Culturelle, Gefilus, LGG
Lactobacillus rhamnosus GG
laboratory biomarker analysis was not performed because of no differences in the clinical outcomesOTHER

Correlative studies

Lactobacillus rhamnosus GG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rutgers Cancer Institute of New Jersey

New Brunswick, New Jersey, 08903, United States

Location

MeSH Terms

Conditions

Graft vs Host Disease

Condition Hierarchy (Ancestors)

Immune System Diseases

Results Point of Contact

Title
Roger Strair, MD, PhD
Organization
Rutgers Cancer Institute of New Jersey
strairrk@cinj.rutgers.edu
732-235-7298

Study Officials

  • Roger Strair

    Rutgers Cancer Institute of New Jersey

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Medicine, RWJMS

Study Record Dates

First Submitted

May 20, 2014

First Posted

May 22, 2014

Study Start

February 18, 2013

Primary Completion

February 28, 2016

Study Completion

February 28, 2018

Last Updated

April 27, 2021

Results First Posted

November 16, 2018

Record last verified: 2021-04

Locations

US(1)