Clinical trial NCT04003181: The Pathogenesis of Chronic Diarrhoea After Treatment for Cancer in Cecum and the Ascending Colon
Official title: The Pathogenesis of Chronic Diarrhoea After Treatment for Cancer in Cecum and the Ascending Colon
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Colon Adenocarcinoma
Diarrhea
Keywords: Bile acid malabsorption
Small intestinal bacterial overgrowth
Lead sponsor: University of Aarhus
Sponsor class: OTHER
Collaborators: name: Danish Cancer Society
name: GE Healthcare
First posted: 2019-07-01
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: DIAGNOSTIC

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Primary adenocarcinoma in cecum or the ascending colon
* Right-sided hemicolectomy
* Understanding, speaking and reading Danish

Exclusion Criteria:

* 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

Primary outcomes:
measure: Change in SeHCAT retention after 7 days.
timeFrame: The SeHCAT scan consists of a baseline measurement and a measurement after 7 days.
measure: Serum concentration of FGF19
timeFrame: Through study completion, an average of 1 month.
Secondary outcomes:
measure: Presence of bacteria in the small bowel
timeFrame: Through study completion, an average of 1 month.
measure: Symptom relief after treatment with antibiotics or bile acid binder
timeFrame: After 3 months.
measure: Quality of life after treatment with antibiotics or bile acid binder
timeFrame: After 3 months.
Other outcomes:
Locations:
city: Aarhus
country: Denmark
facility: Department of Hepatology and Gastroenterology, Aarhus University Hospital
Study officials:
affiliation: Department of Surgery, Aarhus University Hospital
name: Søren Laurberg, MD DMSc
role: STUDY_CHAIR
References: