NCT01010867

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 31 (actual)
• Sponsor: Columbia University · Academic / Other
• Sex: All
• Age: 2 Years – 17 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Hematopoietic Organs; Disorder

Interventions

Type	Name	Description
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)

Timeline

• Start date: 2010-02-01
• Primary completion: 2014-10-01
• Completion: 2014-10-01
• First posted: 2009-11-10
• Last updated: 2017-07-13
• Results posted: 2017-07-13

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated drug study