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Probiotic Use in Children Undergoing Hematopoietic Stem Cell Transplantation (HSCT)

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ClinicalTrials.gov Identifier: NCT01010867
Recruitment Status : Completed
First Posted : November 10, 2009
Results First Posted : July 13, 2017
Last Update Posted : July 13, 2017
Sponsor:
Collaborators:
Johns Hopkins All Children's Hospital
Nemours Children's Clinic
Information provided by (Responsible Party):
Columbia University

Tracking Information
First Submitted Date  ICMJE November 6, 2009
First Posted Date  ICMJE November 10, 2009
Results First Submitted Date  ICMJE November 9, 2015
Results First Posted Date  ICMJE July 13, 2017
Last Update Posted Date July 13, 2017
Study Start Date  ICMJE February 2010
Actual Primary Completion Date October 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 11, 2017)
Number of Lactobacillus Plantarum Bacteremia Infections [ Time Frame: 36 days (day -7 to +28 of HSCT) ]
Original Primary Outcome Measures  ICMJE
 (submitted: November 9, 2009)
Safety endpoint: occurrence of Lactobacillus plantarum bacteremia [ Time Frame: 38 days (day -7 to +30 of HSCT) ]
Change History Complete list of historical versions of study NCT01010867 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: July 11, 2017)
  • Adherence With the Prescribed Dose, Measured as the Percentage of Prescribed Probiotic Doses [ Time Frame: 22 days (day -7 to +14 of HSCT) ]
    To determine the feasibility of administration of L. plantarum 299 and 299v. The treatment is considered feasible for a patient if he/she received at least 50% of the probiotic dose (>= 11 days of treatment).
  • Number of Non-lactobacillus Infections [ Time Frame: 36 days (day -7 to +28 of HSCT) ]
    To determine incidence of bacteremia in HSCT patients who have been administered lactobacillus plantarum.
  • Number of Acute Graft Versus Host Disease (GVHD) Events in HSCT Patients Who Have Been Administered Lactobacillus Plantarum [ Time Frame: Up to Day +100 of HSCT ]
Original Secondary Outcome Measures  ICMJE
 (submitted: November 9, 2009)
  • The feasibility of administration of L. plantarum 299and 299v [ Time Frame: 38 days (day -7 to +30 of HSCT) ]
  • 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) ]
  • 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) ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Probiotic Use in Children Undergoing Hematopoietic Stem Cell Transplantation (HSCT)
Official Title  ICMJE 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) - A Pilot Study
Brief Summary

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 graft versus host disease (GVHD) in HSCT patients who have been administered Lactobacillus plantarum.
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. This study is to evaluate the safety and feasibility of administering probiotics to children and adolescents undergoing HSCT.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Condition  ICMJE Hematopoietic Organs; Disorder
Intervention  ICMJE 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.

Colony forming units (CFU)

Other Name: Probiotics
Study Arms  ICMJE 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.
Intervention: Drug: Lactobacillus plantarum strains 299 and 299v
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 11, 2017)
31
Original Estimated Enrollment  ICMJE
 (submitted: November 9, 2009)
45
Actual Study Completion Date  ICMJE October 2014
Actual Primary Completion Date October 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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 human leukocyte antigen (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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 2 Years to 17 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01010867
Other Study ID Numbers  ICMJE AAAE0846
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Columbia University
Study Sponsor  ICMJE Columbia University
Collaborators  ICMJE
  • Johns Hopkins All Children's Hospital
  • Nemours Children's Clinic
Investigators  ICMJE
Principal Investigator: Michael Neider, MD Johns Hopkins All Children's Hospital
Principal Investigator: Monica Bhatia, MD Columbia University
Principal Investigator: Elena J Ladas, PhD, RD Columbia University
PRS Account Columbia University
Verification Date July 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP