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

Status

UNKNOWN

Phases

Phase 2Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02085694

Enrollment

Registered

2014-03-13

Start date

2014-03-31

Completion date

2014-12-31

Last updated

2014-03-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Mucositis

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.

Interventions

DRUGLactobacillus brevis CD2

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

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

Design outcomes

Primary

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

Secondary

Measure	Time frame
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

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026