Lactobacillus Brevis CD2 Preventing Oral Mucositis

Catholic University of the Sacred Heart

Status and phase: Unknown; Phase 3; Phase 2

Conditions: Mucositis

Treatments: Drug: Lactobacillus brevis CD2

Study type: Interventional

Funder types: Other

Identifiers

NCT02085694

001/14

Details and patient eligibility

About

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.

Enrollment: 10 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No 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

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

Lactobacillus brevis CD2 lozenges

Experimental group

Treatment:

Drug: Lactobacillus brevis CD2