Lactobacillus Brevis CD2 Preventing Oral Mucositis

Overview

A pilot study on efficacy of Lactobacillus CD2 lozenges in preventing oral mucositis (OM) by high-dose chemotherapy with autologous hematopoietic stem cell transplantation. To test whether the probiotic Lactobacillus brevis CD2 lozenges can reduce the incidence and severity of high-dose chemotherapy conditioning regimen induced OM in patients undergoing HSCT. Clinical activity will be defined as reduction in the incidence of chemotherapy induced OM in the patients undergoing HSCT.

Full Title of Study: “A Pilot Study on the Efficacy of Lactobacillus Brevis CD2 Lozenges in Preventing Oral Mucositis by High-dose Chemotherapy With Autologous Hematopoietic Stem Cell Transplantation”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Prevention
    • Masking: None (Open Label)
  • Study Primary Completion Date: November 2014

Interventions

  • Drug: Lactobacillus brevis CD2

Arms, Groups and Cohorts

  • Experimental: Lactobacillus brevis CD2 lozenges

Clinical Trial Outcome Measures

Primary Measures

  • COMMON TERMINOLOGY CRITERIA FOR ADVERSE EVENTS v4.03 (CTCAE) for evaluation of change in oral mucositis
    • Time Frame: days -14;-7; 0;+7;+14;+21

Secondary Measures

  • COMMON TERMINOLOGY CRITERIA FOR ADVERSE EVENTS v4.03 (CTCAE) to determine the incidence of Grade I and II OM
    • Time Frame: days -14;-7; 0; +7;+14; +21

Participating in This Clinical Trial

Inclusion Criteria

  • Age between 18 and 65 years – Karnofsky Performance Score ≥ 70%. – Confirmed histological diagnosis of multiple myeloma for which HSCT is as approved modality of therapy – Patients eligible to receive high-dose chemotherapy as part of conditioning regimen – Concomitant co morbid condition if present, controlled by ongoing treatments (e.g. hypertension, diabetes and so on) – Serum creatinine < 1.8mg/dl – Total bilirubin < 2mg/dl – Liver enzymes within three times of normal limit – Expected survival > 6 months. Exclusion Criteria:

  • Pregnant women and lactating mothers – Patients with history of HIV infection – Patients who have taken any other investigational product in last 4 weeks – Patients having untreated symptomatic dental infection – Patients with WHO Grade 3 or 4 oral Mucositis – Other serious concurrent illness – Inconclusive hematological diagnosis – Patients with signs and symptoms of systemic infections – Patient's/guardian's refusal to sign informed consent

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 65 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Catholic University of the Sacred Heart
  • Provider of Information About this Clinical Study
    • Principal Investigator: sabrina giammarco, MD – Catholic University of the Sacred Heart

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