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

• 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: Columbia University
• Collaborators: Johns Hopkins All Children's Hospital; Nemours Children's Clinic
• Information provided by (Responsible Party): Columbia University

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Hematopoietic Organs; Disorder	Drug: Lactobacillus plantarum strains 299 and 299v	Phase 1

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 31 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (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) - A Pilot Study
• Study Start Date: February 2010
• Actual Primary Completion Date: October 2014
• Actual Study Completion Date: October 2014

Arms and Interventions

Arm	Intervention/treatment
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. Colony forming units (CFU); Other Name: Probiotics

Outcome Measures

Primary Outcome Measures :

1. Number of Lactobacillus Plantarum Bacteremia Infections [ Time Frame: 36 days (day -7 to +28 of HSCT) ]

Secondary Outcome Measures :

1. 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).
2. 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.
3. 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 ]

Eligibility Criteria

• Ages Eligible for Study: 2 Years to 17 Years (Child)
• Sexes Eligible for Study: All
• 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 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.

Contacts and Locations

Locations

United States, Florida

Nemours Children's Clinic

Jacksonville, Florida, United States, 32207

All Children's Hospital

Saint Petersburg, Florida, United States, 33701

United States, New York

Columbia Universtiy Medical Center

New York, New York, United States, 10032

Sponsors and Collaborators

Columbia University

Johns Hopkins All Children's Hospital

Nemours Children's Clinic

Investigators

• 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

More Information

• Responsible Party: Columbia University
• ClinicalTrials.gov Identifier: NCT01010867
• Other Study ID Numbers: AAAE0846
• First Posted: November 10, 2009
• Results First Posted: July 13, 2017
• Last Update Posted: July 13, 2017
• Last Verified: July 2017

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Undecided

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Columbia University:

Probiotics; Hematopoietic Stem Cell Transplantation; Pediatrics