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

2014-08-27 03:18:04 | BioPortfolio

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 GVHD in HSCT patients who have been administered Lactobacillus plantarum

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.

Study Design

Allocation: Non-Randomized, Control: Uncontrolled, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Conditions

Hematopoietic Stem Cell Transplantation

Intervention

Lactobacillus plantarum strains 299 and 299v

Location

All Children's Hospital
St. Petersburg
Florida
United States
33701

Status

Not yet recruiting

Source

Columbia University

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:18:04-0400

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Prevention of Clostridium Difficile Infections Using Lactobacillus Plantarum 299v Strain

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PubMed Articles [21362 Associated PubMed Articles listed on BioPortfolio]

THE OUTCOME OF ALLOGENEIC HEMATOPOIETIC STEM CELL TRANSPLANTATION FOR INHERITED DISEASES IS INFLUENCED BY HLA MATCH, YEAR OF TRANSPLANTATION AND IMMUNIZED FEMALE DONOR.

For many inborn errors of metabolism (IEM), allogeneic hematopoietic stem cell transplantation (HUSCT) is the only cure.

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Medical and Biotech [MESH] Definitions

Transfer of HEMATOPOIETIC STEM CELLS from BONE MARROW or BLOOD between individuals within the same species (TRANSPLANTATION, HOMOLOGOUS) or transfer within the same individual (TRANSPLANTATION, AUTOLOGOUS). Hematopoietic stem cell transplantation has been used as an alternative to BONE MARROW TRANSPLANTATION in the treatment of a variety of neoplasms.

The release of stem cells from the bone marrow into the peripheral blood circulation for the purpose of leukapheresis, prior to stem cell transplantation. Hematopoietic growth factors or chemotherapeutic agents often are used to stimulate the mobilization.

The transference of BONE MARROW from one human or animal to another for a variety of purposes including HEMATOPOIETIC STEM CELL TRANSPLANTATION or MESENCHYMAL STEM CELL TRANSPLANTATION.

Transplantation of STEM CELLS collected from the fetal blood remaining in the UMBILICAL CORD and the PLACENTA after delivery. Included are the HEMATOPOIETIC STEM CELLS.

Transplantation of stem cells collected from the peripheral blood. It is a less invasive alternative to direct marrow harvesting of hematopoietic stem cells. Enrichment of stem cells in peripheral blood can be achieved by inducing mobilization of stem cells from the BONE MARROW.

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