Lactobacillus Brevis CD2 Preventing Oral Mucositis
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
1 other identifier
interventional
10
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Mar 2014
Shorter than P25 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2014
CompletedFirst Submitted
Initial submission to the registry
March 6, 2014
CompletedFirst Posted
Study publicly available on registry
March 13, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2014
CompletedMarch 13, 2014
March 1, 2014
8 months
March 6, 2014
March 8, 2014
Conditions
Outcome Measures
Primary Outcomes (1)
COMMON TERMINOLOGY CRITERIA FOR ADVERSE EVENTS v4.03 (CTCAE) for evaluation of change in oral mucositis
days -14;-7; 0;+7;+14;+21
Secondary Outcomes (1)
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
Study Arms (1)
Lactobacillus brevis CD2 lozenges
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Policlinico Universitario "A. GEMELLI"
Rome, Rome, 00168, Italy
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD
Study Record Dates
First Submitted
March 6, 2014
First Posted
March 13, 2014
Study Start
March 1, 2014
Primary Completion
November 1, 2014
Study Completion
December 1, 2014
Last Updated
March 13, 2014
Record last verified: 2014-03