Probiotic Use in Children Undergoing Hematopoietic Stem Cell Transplantation (HSCT) - A Pilot Study

This study is currently recruiting participants.
Verified May 2012 by Columbia University
Sponsor:
Collaborator:
All Children’s Hospital Johns Hopkins Medicine
Information provided by (Responsible Party):
Monica Bhatia, Columbia University
ClinicalTrials.gov Identifier:
NCT01010867
First received: November 6, 2009
Last updated: May 18, 2012
Last verified: May 2012
  Purpose

Primary Objective:

  1. To evaluate the safety of orally administered Lactobacillus plantarum strains 299 and 299v, a probiotic, in patients undergoing allogeneic myeloablative HSCT, as measured by incidence of Lactobacillus plantarum bacteremia.

Secondary Objectives:

  1. To investigate the feasibility of administering Lactobacillus plantarum 299 and 299v to children and adolescents undergoing HSCT.
  2. To describe the overall incidence of bacteremia in HSCT patients who have been administered Lactobacillus plantarum.
  3. To describe the overall incidence of acute GVHD in HSCT patients who have been administered Lactobacillus plantarum

Condition Intervention Phase
Hematopoietic Stem Cell Transplantation
Dietary Supplement: Lactobacillus plantarum strains 299 and 299v
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: A Limited Institution Pilot Trial Evaluating the Safety of Administering the Probiotic, Lactobacillus Plantarum, to Children and Adolescents Undergoing Allogenic Hematopoietic Stem Cell Transplantation (HSCT)

Resource links provided by NLM:


Further study details as provided by Columbia University:

Primary Outcome Measures:
  • Safety endpoint: occurrence of Lactobacillus plantarum bacteremia [ Time Frame: 38 days (day -7 to +30 of HSCT) ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • The feasibility of administration of L. plantarum 299and 299v [ Time Frame: 38 days (day -7 to +30 of HSCT) ] [ Designated as safety issue: No ]
  • To describe the overall incidence of bacteremia in HSCT patients who have been administered Lactobacillus plantarum [ Time Frame: 38 days (day -7 to +30 of HSCT) ] [ Designated as safety issue: Yes ]
  • To describe the overall incidence of acute GVHD in HSCT patients who have been administered Lactobacillus plantarum [ Time Frame: 38 days (day -7 to +30 of HSCT) ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 45
Study Start Date: November 2009
Estimated Study Completion Date: October 2015
Estimated Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Intervention Details:
    Dietary Supplement: Lactobacillus plantarum strains 299 and 299v
    Patients will receive a daily dose of Lactobacillus plantarum: 1 x10^8 CFU/kg/day. This supplement will be supplied in sachets of powder and will be mixed in water (certain water-based liquid) that is no warmer that 37o C.
    Other Name: Probiotics
Detailed Description:

Myeloablative regimens are the backbone of hematopoietic stem cell transplantation (HSCT) and are associated with prolonged periods of cachexia/anorexia, nausea/vomiting, mucositis, and compromised gut integrity (CGI). The toxicities associated with HSCT often lead to prolonged periods of poor oral intake and may result in overt malnutrition. CGI decreases oral tolerance to foods, reduces QOL and functional status, delays the transition from the hospital to home setting, and increases the risk of the development of gut-derived infections. Probiotics are nutritional supplements that contain a defined amount of viable microorganisms and upon administration confer a benefit to the host. Clinical trials in adults receiving organ transplants have found probiotics decrease the incidence of infection, the duration of antibiotic use, the incidence of multiorgan failure and systemic inflammation. Children and adolescents undergoing HSCT, experience similar clinical challenges suggesting probiotics may have a therapeutic value in the setting of HSCT. We are proposing to evaluate the safety and feasibility of administering probiotics to children and adolescents undergoing HSCT.

  Eligibility

Ages Eligible for Study:   2 Years to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • All patients undergoing myeloablative allogeneic HSCT will be eligible. The source of stem cells can be from bone marrow, umbilical cord blood or cytokine mobilized peripheral blood. Donor can be HLA matched sibling or parent, a related donor mismatched for a single HLA locus (class I or II), unrelated marrow or peripheral blood stem cell donor, or unrelated cord blood at least 4/6 antigen match (Class 1 or II).
  • Patients of either gender and between 2 and 17.99 years of age
  • Patients receiving any type of GVHD prophylaxis are eligible.

Exclusion Criteria:

  • Patients who have self-prescribed probiotics within 3 months of starting the conditioning regimen for stem cell transplant (consumption of yogurt products is allowed).
  • Patients with known allergy to oats.
  • Patients who have had any type of gut damage within the past three months; such as, previous bowel perforations; previous episode of Grade 4 neutropenic colitis or typhlitis.
  • Patients with inflammatory bowel syndrome, short small bowel syndrome, Crohns Disease, Ulcerative Colitis, and patients with a history of bowel resections.
  • Patients who have undergone a previous allogeneic HSCT.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01010867

Contacts
Contact: Michael Nieder, MD (727)767-6856 NiederM@allkids.org
Contact: Monica Bhatia, MD (212) 303-9138 mb2476@columbia.edu

Locations
United States, Florida
All Children's Hospital Recruiting
St. Petersburg, Florida, United States, 33701
Principal Investigator: Michael Nieder, MD         
United States, New York
Columbia Universtiy Medical Center Recruiting
New York, New York, United States, 10032
Principal Investigator: Monica Bhatia, MD         
Sub-Investigator: Elena Ladas, MS, RD         
Sub-Investigator: Kara Kelly, MD         
Sponsors and Collaborators
Columbia University
All Children’s Hospital Johns Hopkins Medicine
Investigators
Principal Investigator: Michael Neider, MD All Children’s Hospital Johns Hopkins Medicine
Principal Investigator: Monica Bhatia, MD Columbia University
  More Information

No publications provided

Responsible Party: Monica Bhatia, Assistant Clinical Professor of Pediatrics, Columbia University
ClinicalTrials.gov Identifier: NCT01010867     History of Changes
Other Study ID Numbers: AAAE0846
Study First Received: November 6, 2009
Last Updated: May 18, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Columbia University:
Probiotics
Hematopoietic Stem Cell Transplantation
Pediatrics

ClinicalTrials.gov processed this record on April 23, 2014