CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 31 enrolled
Drug / intervention
Lactobacillus plantarum strains 299 and 299vdrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01010867
NCT01010867Phase 1Completed
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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

Columbia University·interventional·Posted Nov 10, 2009·Updated Jul 13, 2017

In Brief

A Phase 1 clinical trial evaluating Lactobacillus plantarum strains 299 and 299v for Hematopoietic Organs; Disorder. Completed, enrolled 31 participants across 3 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHematopoietic Organs; Disorder
CountriesUnited States
CollaboratorsJohns Hopkins All Children's Hospital, Nemours Children's Clinic

Timeline

Phase 1CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedNov 10, 2009
Enrollment StartFeb 1, 2010
Primary CompletionOct 1, 2014
TodayJul 2, 2026
Enrollment to primary: 4.7 yearsPosted 16.6 years ago

Interventions

Lactobacillus plantarum strains 299 and 299vdrug

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)