Lactobacillus Brevis CD2 Preventing Oral Mucositis

NCT ID: NCT02085694

Last Updated: 2014-03-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

PHASE2/PHASE3

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-03-31

Study Completion Date

2014-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Mucositis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Lactobacillus brevis CD2 lozenges

Group Type EXPERIMENTAL

Lactobacillus brevis CD2

Intervention Type DRUG

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Lactobacillus brevis CD2

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Catholic University of the Sacred Heart

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

sabrina giammarco

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Policlinico Universitario "A. GEMELLI"

Rome, Rome, Italy

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Italy

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Patrizia Chiusolo, MD

Role: primary

0039-0630155300

Sabrina Giammarco, MD

Role: backup

0039-0630155300

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

001/14

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.