NCT02085694Unknown2 期
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
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- COMMON TERMINOLOGY CRITERIA FOR ADVERSE EVENTS v4.03 (CTCAE) for evaluation of change in oral mucositis
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
研究组 & 干预措施
Lactobacillus brevis CD2 lozenges
Experimental
干预措施: Lactobacillus brevis CD2 (Drug)
结局指标
主要结局
COMMON TERMINOLOGY CRITERIA FOR ADVERSE EVENTS v4.03 (CTCAE) for evaluation of change in oral mucositis
时间窗: days -14;-7; 0;+7;+14;+21
次要结局
- 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)
研究者
sabrina giammarco
MD
Catholic University of the Sacred Heart
研究点 (1)
Loading locations...
相似试验
撤回
3 期
CD2 Lozenges in Preventing Acute Oral Mucositis in Patients With Head and Neck Cancer Receiving Radiotherapy and ChemotherapyHead and Neck CancerOral Complications of Radiation TherapyPainWeight ChangesNCT01545687Alliance for Clinical Trials in Oncology
已完成
2 期
Mucositis is one of the most common problem in patients who are undergoing stem cell transplant receiving high dose chemotherapy in patients undergoing hematopoietic stem cell transplantation.CTRI/2011/11/002140CD Pharma India pvt ltd20
Unknown
4 期
Anticaries Effect of Probiotic Lactobacillus Brevis CD2 (Lb CD2).Dental CariesGingivitisNCT01778699Università degli Studi di Sassari440
Unknown
1 期
Evaluation of the Consumption of a Probiotic on the Load of S. Agalactiae.Streptococcus AgalactiaeNCT04165551Biosearch S.A.60
已完成
不适用
L. Brevis CD2 Strain Persistence in Oral CavityOral HealthNCT01782079University of Roma La Sapienza12