The Pathogenesis of Chronic Diarrhoea After Treatment for Cancer in Cecum and the Ascending Colon
NCT ID: NCT04003181
Last Updated: 2021-09-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
64 participants
INTERVENTIONAL
2017-09-28
2021-05-26
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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NON_RANDOMIZED
FACTORIAL
DIAGNOSTIC
NONE
Study Groups
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Positive breath test
Patients with a positive breath test are treated with antibiotics.
Antibiotics
Ciprofloxacin or Rifaximin for 10 days.
Positive SeHCAT scan
Patients with a positive SeHCAT scan are treated with a bile acid binder.
Bile Acid Binder
Cholestyramine or Colesevelam lifelong.
No intervention
Patients with a normal breath test and a normal SeHCAT scan receive no intervention.
No interventions assigned to this group
Interventions
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Antibiotics
Ciprofloxacin or Rifaximin for 10 days.
Bile Acid Binder
Cholestyramine or Colesevelam lifelong.
Eligibility Criteria
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Inclusion Criteria
* Right-sided hemicolectomy
* Understanding, speaking and reading Danish
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Danish Cancer Society
OTHER
GE Healthcare
INDUSTRY
University of Aarhus
OTHER
Responsible Party
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Principal Investigators
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Søren Laurberg, MD DMSc
Role: STUDY_CHAIR
Department of Surgery, Aarhus University Hospital
Locations
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Department of Hepatology and Gastroenterology, Aarhus University Hospital
Aarhus, , Denmark
Countries
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Other Identifiers
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1-16-02-137-17
Identifier Type: OTHER
Identifier Source: secondary_id
1-10-72-301-16
Identifier Type: -
Identifier Source: org_study_id
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