The Effectiveness of Oral Lactobacillus Rhamnosus TCELL-1 Upon Colorectal Cancer
试验速览
- 阶段
- 2 期
- 入组人数
- 56
- 试验地点
- 1
- 主要终点
- Changes in quality of life assessed by (WHOQOL)-BREF Taiwan version
研究概览
简要总结
Emerging evidences have shown that gut microbiota have played roles in the modulation of chemotherapy agents for cancer patients receiving chemotherapy. Probiotics are gut microbiota beneficial to human body. However, little was known about the role of probiotics for cancer patients receiving chemotherapy. Lactobacillus rhamnosus TCELL-1 is a kind of probiotics which were isolated from the gut mucosa of healthy Taiwanese. The aim of the study was to evaluate the effect of Lactobacillus rhamnosus TCELL-1 upon staged III colorectal cancer patients receiving adjuvant chemotherapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Double (Participant, Investigator)
盲法说明
The patient were given bottle of placebo with same appearance of bottle of probiotics.
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Aged older than 20 years (inclusive) of either gender
- •Expressed interest and ability to fulfill the study requirements.
- •Be in general good health as determined by the first evaluation within 30 days of the first dose of Lactobacillus Rhamnosus TCELL-1
- •Able to ingest the study drug (Lactobacillus Rhamnosus TCELL-1) dissolved in a small amount of cow's milk or soy milk orally (no feeding tube).
- •Willing to prevent pregnancy - Women must agree not to become pregnant or breastfeed from the time of study enrollment until at least 3 months after the last dose of study drug. If a woman is sexually active and has no history of hysterectomy or tubal ligation, she must agree to practice an acceptable method of birth control, such as hormonal or barrier birth control. A woman is eligible if she is monogamous with a vasectomized male. Sexually active male volunteers without vasectomy must agree to use a barrier method of contraception for 3 months after the last dose of study drug.
- •Willing to comply with protocol and report on compliance and side effects during study period.
- •Informed consent obtained and signed prior to screening.
排除标准
- •Women who are pregnant or breast-feeding or with child-bearing potential but unable or unwilling to practice a highly effective means of contraception
- •With uncontrolled infection or serious infection within the past 4 weeks
- •Patients who took antibiotics for some reasons within the past 4 weeks
- •Patients who must eat probiotics product for some reasons
- •Active substance abuse, including alcohol, which, in the opinion of the investigator, risks impairing the ability of the patient to comply with the protocol
- •History of allergy to any substance of investigational products
- •With known human immunodeficiency virus (HIV) infection
- •Judged to be not applicable to this study by investigator such as difficulty of follow-up observation
- •With any other serious diseases/medical history considered by the investigator not in the condition to enter the trial
- •Having participated other investigational study within 4 weeks of entering this study
结局指标
主要结局
Changes in quality of life assessed by (WHOQOL)-BREF Taiwan version
时间窗: 1 year
THE WORLD HEALTH ORGANIZATION QUALITY OF LIFE (WHOQOL)-BREF Taiwan version
Changes in quality of life assessed by EORTC QLQ-CR30
时间窗: 1 year
EORTC QLQ-CR30
Chinese version of EORTC quality of life questionnaire(QLQ)-C30
时间窗: 1 year
The Functional Assessment of Cancer Therapy (FACT)-G version 4
时间窗: 1 year
Changes in FACT-F version 4 at each post-treatment visit compared to baseline
时间窗: 1 year
Changes of irritable bowel symptoms
时间窗: 1 year
The irritable bowel symptoms will be evaluated with the Rome IV criteria of irritable bowel disease
次要结局
- Change of fecal microbiota features(1 year)
- Change of fecal metabolites(1 year)
- Incidence of adverse events(1 year)
- The change of body weight(1 year)
- The presence of bacteremia(1 year)
- Change of serum cytokines(1 year)