The Pathogenesis of Chronic Diarrhoea After Treatment for Cancer in Cecum and the Ascending Colon
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 64
- 试验地点
- 1
- 主要终点
- Serum concentration of FGF19
研究概览
简要总结
Many patients suffer from chronic diarrhoea after surgical treatment for cancer in the right side of the colon.
The investigators' main hypothesis is that colon cancer patients with chronic diarrhoea have a higher risk of bile acid malabsorption compared with colon cancer patients without diarrhoea.
The investigators also expect that a part of the cases of bile acid malabsorption is caused by underlying bacterial overgrowth in the small bowel.
The investigators assume that patients with severe bile acid malabsorption have a lower value of FGF19 in the blood compared to patients with moderate or none bile acid malabsorption.
Furthermore, it is assumed that patients with chronic diarrhoea and documented bile acid malabsorption after surgical treatment for right-sided colon cancer will get improved bowel function when treated with a bile acid binder, or antibiotics in case of bacterial overgrowth.
详细描述
Patients with chronic diarrhoea after surgical treatment of right-sided colon cancer will be compared to patients without diarrhoea after right-sided colon cancer treatment.
All patients will be asked to answer a short questionnaire regarding bowel function, and they will all have standard blood tests taken to exclude non-cancer related causes of diarrhoea. Besides these standard tests, the value of FGF19 will be measured in a blood sample from the fasting participants. All participants will undergo SeHCAT scan to determine the presence of bile acid malabsorption among right-sided colon cancer patients with and without diarrhoea. In addition, a glucose breath test will be performed to examine, if the patients have small intestinal bacterial overgrowth.
Patients with a positive glucose breath test, and thus bacterial overgrowth, will be treated with antibiotics, followed by another SeHCAT scan, glucose breath test, and measurement of gastrointestinal transit time. In addition, they will be asked to complete the questionnaire regarding bowel function again. All cases with an abnormal SeHCAT scan will be treated with a bile acid binder, and the patients will be asked to complete the questionnaire one more time, and the GITT measurement will be repeated.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Factorial
- 主要目的
- Diagnostic
- 盲法
- None
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
- •Primary adenocarcinoma in cecum or the ascending colon
- •Right-sided hemicolectomy
- •Understanding, speaking and reading Danish
排除标准
- •Previous major gastrointestinal, urological or gynaecological surgery or oncological treatment
- •Radiation therapy
- •Recurrence of colon cancer
- •Metastasis
- •Permanent stoma
- •Pregnancy
- •Reduced cognitive level that makes it plausible that the patient do not understand the study or is not capable of participation
研究组 & 干预措施
Positive breath test
Patients with a positive breath test are treated with antibiotics.
干预措施: Antibiotics (Drug)
Positive SeHCAT scan
Patients with a positive SeHCAT scan are treated with a bile acid binder.
干预措施: Bile Acid Binder (Drug)
结局指标
主要结局
Serum concentration of FGF19
时间窗: Through study completion, an average of 1 month.
The serum value of FGF19 is measured by a blood sample.
Change in SeHCAT retention after 7 days.
时间窗: The SeHCAT scan consists of a baseline measurement and a measurement after 7 days.
The diagnosis of bile acid malabsorption in cases vs. controls is determined by a positive SeHCAT scan.
次要结局
- Quality of life after treatment with antibiotics or bile acid binder(After 3 months.)
- Symptom relief after treatment with antibiotics or bile acid binder(After 3 months.)
- Presence of bacteria in the small bowel(Through study completion, an average of 1 month.)