NCT02559349已完成不适用
Gut Microbiota And Radiotherapy
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Number of subject providing stool samples
研究概览
简要总结
A pilot, single arm, single center study to determine the feasibility of obtaining stool samples from adult patients receiving SBRT to a lung tumor, if SBRT induces changes in the gut microbiota and to obtain preliminary data about possible correlation of baseline composition and changes in gut microbiota with tumor response, local control, and development of pneumonitis/other side effects.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Patient is planned to receive Stereotactic Body Radiotherapy (SBRT) to a lung lesion (either presumed or biopsy-proven NSCLC
- •Age 18 years old or older
- •Patient capable of giving informed consent
- •Exclusion Criteria
- •Use of antibiotics, antifungal, antivirals or antiparasitics during the 4 weeks prior to registration
- •Active infection with oral temperature >100°F
- •Use of corticosteroids, methotrexate or immunosuppressive drugs during the 4 weeks prior to registration
- •Use of chemotherapy during the 4 weeks prior to radiotherapy or during radiotherapy. Chemotherapy cannot begin before the collection of the 30-day post treatment sample (S4).
- •Confirmed or suspected HIV, HBV or HCV
- •Chronic constipation (bowel movements less frequent than every other day)
- •Active uncontrolled gastrointestinal disorders such as inflammatory bowel disease, moderate/severe irritable bowel syndrome, persistent, infectious gastroenteritis, colitis or gastritis, persistent or chronic diarrhea of unknown etiology, Clostridium Difficile infection (recurrent) or Helicobacter Pylori infection (untreated)
- •Major surgery of the GI tract, with the exception of cholecystectomy and appendectomy, in the past five years. Any major bowel resection at any time
- •Patients on anti-diarrheal medications
- •Patients on probiotics
排除标准
- 未提供
结局指标
主要结局
Number of subject providing stool samples
时间窗: 2 years
次要结局
未报告次要终点
研究者
研究点 (1)
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