Lactobacillus Brevis CD2 Preventing Oral Mucositis

March 8, 2014 updated by: sabrina giammarco, Catholic University of the Sacred Heart

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

10

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Rome, Italy, 00168
        • Recruiting
        • Policlinico Universitario "A. GEMELLI"
        • Contact:
        • Contact:
        • Sub-Investigator:
          • Sabrina Giammarco, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Lactobacillus brevis CD2 lozenges
Drug: Lactobacillus brevis CD2

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
days -14;-7; 0;+7;+14;+21

Secondary Outcome Measures

Outcome Measure
Time Frame
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
days -14;-7; 0; +7;+14; +21

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Catholic University of the Sacred Heart

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2014

Primary Completion (Anticipated)

November 1, 2014

Study Completion (Anticipated)

December 1, 2014

Study Registration Dates

First Submitted

March 6, 2014

First Submitted That Met QC Criteria

March 8, 2014

First Posted (Estimate)

March 13, 2014

Study Record Updates

Last Update Posted (Estimate)

March 13, 2014

Last Update Submitted That Met QC Criteria

March 8, 2014

Last Verified

March 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 001/14

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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