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

NCT01010867 | Completed Phase 1 Results DMC FDA Drug

• 1 other identifier: AAAE0846
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 3

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

Conditions

Hematopoietic Organs; Disorder

Keywords

Probiotics; Hematopoietic Stem Cell Transplantation; Pediatrics

Outcome Measures

Primary Outcomes (1)

• Number of Lactobacillus Plantarum Bacteremia Infections

  36 days (day -7 to +28 of HSCT)

Secondary Outcomes (3)

• Adherence With the Prescribed Dose, Measured as the Percentage of Prescribed Probiotic Doses

  22 days (day -7 to +14 of HSCT)

• Number of Non-lactobacillus Infections

  36 days (day -7 to +28 of HSCT)

• Number of Acute Graft Versus Host Disease (GVHD) Events in HSCT Patients Who Have Been Administered Lactobacillus Plantarum

  Up to Day +100 of HSCT

Study Arms (1)

Lactobacillus plantarum

EXPERIMENTAL

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

Interventions

Lactobacillus plantarum strains 299 and 299v DRUG

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)

Also known as: Probiotics

Lactobacillus plantarum

Eligibility Criteria

• Age: 2 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Columbia University: lead
• Johns Hopkins All Children's Hospital: collaborator
• Nemours Children's Clinic: collaborator

Study Sites (3)

Nemours Children's Clinic

Jacksonville, Florida, 32207, United States

Location

All Children's Hospital

St. Petersburg, Florida, 33701, United States

Location

Columbia Universtiy Medical Center

New York, New York, 10032, United States

Location

MeSH Terms

Interventions

Probiotics

Intervention Hierarchy (Ancestors)

Dietary Supplements; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Results Point of Contact

• Title: Monica Bhatia, MD
• Organization: Columbia University Medical Center

mb2476@cumc.columbia.edu

2123055808

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 6, 2009
• First Posted: November 10, 2009
• Study Start: February 1, 2010
• Primary Completion: October 1, 2014
• Study Completion: October 1, 2014
• Last Updated: July 13, 2017
• Results First Posted: July 13, 2017

Record last verified: 2017-07

Locations

US (3)