Lactobacillus Brevis CD2 Preventing Oral Mucositis

Phase 2

• Conditions: Mucositis
• Interventions: Drug: Lactobacillus brevis CD2

• Registration Number: NCT02085694
• Lead Sponsor: Catholic University of the Sacred Heart

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2014-03
• Study Start: 2014-03
• Study First Submitted: 2014-03-06
• Study First Submitted QC: 2014-03-08
• Last Update Submitted: 2014-03-08
• Study First Posted: 2014-03-13
• Last Update Posted: 2014-03-13
• Primary Completion: 2014-11
• Study Completion: 2014-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 10

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Lactobacillus brevis CD2 lozenges	Lactobacillus brevis CD2	-

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Policlinico Universitario "A. GEMELLI"; 🇮🇹 Rome, Italy