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Lactobacillus Brevis CD2 Preventing Oral Mucositis

Primary Purpose

Mucositis

Status
Unknown status
Phase
Phase 2
Locations
Italy
Study Type
Interventional
Intervention
Lactobacillus brevis CD2
Sponsored by
Catholic University of the Sacred Heart
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Mucositis

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Policlinico Universitario "A. GEMELLI"Recruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Lactobacillus brevis CD2 lozenges

Arm Description

Outcomes

Primary Outcome Measures

COMMON TERMINOLOGY CRITERIA FOR ADVERSE EVENTS v4.03 (CTCAE) for evaluation of change in oral mucositis

Secondary Outcome Measures

COMMON TERMINOLOGY CRITERIA FOR ADVERSE EVENTS v4.03 (CTCAE) to determine the incidence of Grade I and II OM

Full Information

First Posted
March 6, 2014
Last Updated
March 8, 2014
Sponsor
Catholic University of the Sacred Heart
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1. Study Identification

Unique Protocol Identification Number
NCT02085694
Brief Title
Lactobacillus Brevis CD2 Preventing Oral Mucositis
Official Title
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
Interventional

2. Study Status

Record Verification Date
March 2014
Overall Recruitment Status
Unknown status
Study Start Date
March 2014 (undefined)
Primary Completion Date
November 2014 (Anticipated)
Study Completion Date
December 2014 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Catholic University of the Sacred Heart

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mucositis

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2, Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Lactobacillus brevis CD2 lozenges
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Lactobacillus brevis CD2
Primary Outcome Measure Information:
Title
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 Outcome Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Policlinico Universitario "A. GEMELLI"
City
Rome
ZIP/Postal Code
00168
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Patrizia Chiusolo, MD
Phone
0039-0630155300
Email
p.chiusolo@rm.unicatt.it
First Name & Middle Initial & Last Name & Degree
Sabrina Giammarco, MD
Phone
0039-0630155300
Email
sabrina_giammarco@libero.it
First Name & Middle Initial & Last Name & Degree
Patrizia Chiusolo, MD
First Name & Middle Initial & Last Name & Degree
Sabrina Giammarco, MD

12. IPD Sharing Statement

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Lactobacillus Brevis CD2 Preventing Oral Mucositis

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