Lactobacillus Lozenges as Preventative Care in Low-grade Dysplasia
试验速览
- 阶段
- 3 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Clinical regression of dysplastic lesion
研究概览
简要总结
There are limited evidence-based management options for patients with low-grade oral dysplasia. Despite the risk of malignant transformation, management is frequently limited to risk factor reduction (such as smoking cessation) and clinical surveillance. An intervention for low-grade oral dysplasia which could induce regression or decrease rates of malignant transformation has the potential to be a valuable preventative tool to reduce rates of oral cancer.
The investigators will conduct a randomized clinical trial to investigate if the administration of a probiotic lozenge to patients with low-grade oral dysplasia result in decreased peri-tumoral inflammation as evidenced by impacts on populations of tumor-associated macrophages and tumor-infiltrating lymphocytes, and decreased dysbiosis at the disease site compared with the contralateral normal site. The investigators hypothesize that these changes may increase the rate of clinical regression of these lesions.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Presence of biopsy-proven low-grade or mild oral dysplasia
排除标准
- •Active oral cavity malignancy
- •Active oral cavity high grade dysplasia
- •Currently undergoing chemotherapy or immunotherapy, or have used these agents within the prior 6 months
- •History of external beam radiation therapy to the head and neck area
- •Diagnosis of HIV with decreased CD4 count and/or detectable viral load
- •Current use of systemic or orally absorbed steroids
- •Patient undergoing stem cell transplantation
- •Patients taking anti-rejection medication after stem cell or solid organ transplantation
- •Patients using injectable immunosuppressive drugs for autoimmune disease
- •Pregnant or nursing women
- •Patients who are hospitalized
- •Patients with a heart valve abnormalities or a history of valve replacement or endocarditis
- •Patients with active severe acute intestinal disease (active bowel leak, acute abdomen, active colitis) or a history of short bowel syndrome
研究组 & 干预措施
Probiotic lozenges
Participants in this arm will be be instructed to take a lozenge daily for 6 weeks. They will also receive oral dysplasia standard of care.
干预措施: Probiotic oral lozenges (Biological)
Standard of care for oral dysplasia
Participants in this arm will receive oral dysplasia standard of care.
干预措施: Standard of care for oral dysplasia (Other)
结局指标
主要结局
Clinical regression of dysplastic lesion
时间窗: 6 weeks
This outcome will be assessed using blinded review of clinical photographs and measurements of the lesions to determine if the lesion has regressed, remained the same or progressed since baseline.
次要结局
- Oral dysplasia lesions at 12 weeks(12 weeks)
- Microbiome at the lesion site(baseline, 6 weeks, 12 weeks)
- Change in peri-tumoral inflammation(baseline, 6 weeks)