Impact of Dietary Fiber as Prebiotics on Chemotherapy-related Diarrhea in Patients With Gastrointestinal Tumors
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 试验地点
- 1
- 主要终点
- Therapeutic effect on the chemotherapy-related grade 2 to 4 diarrhea
研究概览
简要总结
This study evaluates longitudinal data associating changes in gut microbiota composition and diversity, defecation, performance status and adverse reactions in response to prebiotic fiber supplementation in patients with gastrointestinal cancer chemotherapy-related diarrhea. 120 adult participants , age 18 to 65 years, will be randomized into one of the two arms. Arm A (intervention group) will receive prebiotic fiber and loperamide hydrochloride capsule(a drug for standard treatment). Arm B will receive maltodextrin placebo and loperamide hydrochloride capsule.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
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 18-65, be able to comply with the protocol
- •Life expectancy greater than 3 months
- •Patients with cytologically or histologically confirmed diagnosis of gastrointestinal cancers
- •Undergoing chemotherapy, not synchronized with radiotherapy and other anti-tumor treatments
- •Chemotherapy-related diarrhea grade 2-4
- •Not experience diarrhea before chemotherapy
排除标准
- •age<18 or >65
- •Patients who cannot eat by mouth for example chewing disorders, difficulty swallowing, intractable vomiting, gastrointestinal obstruction or gastrointestinal tract bleeding
- •Other acute or chronic diarrhea or colostomy
- •Patients with other severe adverse effects of chemotherapy other than diarrhea
- •Patients with severe diseases of heart, kidney, liver and other major organs
- •Use of any other drug for promoting intestine movement
- •Use of any other drug or dietary supplement for chemotherapy-related diarrhea such as other fiber supplements, probiotics, octreotide
- •Allergic to the components of the intervention dietary supplements;
- •Pregnancy (positive serum pregnancy test) and lactation
- •Any other serious or uncontrolled illness which the investigator think is undesirable for the patient to enter the trial
研究组 & 干预措施
Maltodextrin
干预措施: Maltodextrin + loperamide hydrochloride capsule (Dietary Supplement)
Prebiotic Fiber
干预措施: Prebiotic Fiber Supplement + loperamide hydrochloride capsule (Dietary Supplement)
结局指标
主要结局
Therapeutic effect on the chemotherapy-related grade 2 to 4 diarrhea
时间窗: 2 weeks
Numbers of bowel movements per day
次要结局
- Changs in Karnofsky Performance Status(2 weeks)
- onset time(2 weeks)
- Gut microbiota changes in response to intervention(Change from baseline in gut microbiota at 1 and 2 weeks ])
- Adverse events(2 weeks)