Lactobacillus Brevis CD2 Preventing Oral Mucositis

• Status: Unknown status
• Trial end date: 2014-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Catholic University of the Sacred Heart

Criteria

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