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

This study has been completed.
Sponsor:
Collaborators:
All Children’s Hospital Johns Hopkins Medicine
Nemours Children's Clinic
Information provided by (Responsible Party):
Monica Bhatia, Columbia University
ClinicalTrials.gov Identifier:
NCT01010867
First received: November 6, 2009
Last updated: December 15, 2014
Last verified: December 2014
  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 Organs; Disorder
Drug: Lactobacillus plantarum strains 299 and 299v
Phase 1

Study Type: Interventional
Study Design: 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: 36 days (day -7 to +28 of HSCT) ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • The feasibility of administration of L. plantarum 299and 299v [ Time Frame: 22 days (day -7 to +14 of HSCT) ] [ Designated as safety issue: No ]
    The treatment is considered feasible for a patient if he/she received at least 50% of the probiotic dose (>= 11 days of treatment).

  • To describe the overall incidence of bacteremia in HSCT patients who have been administered Lactobacillus plantarum [ Time Frame: 36 days (day -7 to +28 of HSCT) ] [ Designated as safety issue: Yes ]
    An evaluable patient needs to receive at least half of the dose of probiotics and remain on study until Day +28 except when he/she developed the specific endpoint (bacteremia)

  • To describe the overall incidence of acute GVHD in HSCT patients who have been administered Lactobacillus plantarum [ Time Frame: 36 days (day -7 to +28 of HSCT) ] [ Designated as safety issue: Yes ]
    An evaluable patient needs to receive at least half of the dose of probiotics and remain on study until Day +28 except when he/she developed the specific endpoint (GVHD grade 3 or 4)


Enrollment: 30
Study Start Date: February 2010
Study Completion Date: October 2014
Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Lactobacillus plantarum
There is a single intervention arm in this study. Target accrual for the intervention is 30 subjects. Subjects receive supplementation with Lactobacillus plantarum strains 299 and 299v.
Drug: 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 Quality of Life (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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01010867

Locations
United States, Florida
Nemours Children's Clinic
Jacksonville, Florida, United States, 32207
All Children's Hospital
St. Petersburg, Florida, United States, 33701
United States, New York
Columbia Universtiy Medical Center
New York, New York, United States, 10032
Sponsors and Collaborators
Monica Bhatia
All Children’s Hospital Johns Hopkins Medicine
Nemours Children's Clinic
Investigators
Principal Investigator: Michael Neider, MD All Children’s Hospital Johns Hopkins Medicine
Principal Investigator: Monica Bhatia, MD Columbia University
Principal Investigator: Elena J Ladas, PhD, RD 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: December 15, 2014
Health Authority: United States: Institutional Review Board
United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on March 26, 2015