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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lactobacillus brevis CD2 lozenges | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lactobacillus brevis CD2 | Drug |
|
| Measure | Description | 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 |
| Measure | Description | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Policlinico Universitario "A. GEMELLI" | Recruiting | Rome | Rome | 00168 | Italy |
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| ID | Term |
|---|---|
| D052016 | Mucositis |
| ID | Term |
|---|---|
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D009059 | Mouth Diseases |
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| D009057 |
| Stomatognathic Diseases |