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| ID | Type | Description | Link |
|---|---|---|---|
| 1-16-02-137-17 | Other Identifier | Danish Data Protection Agency |
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| Name | Class |
|---|---|
| Danish Cancer Society | OTHER |
| GE Healthcare | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Positive breath test | Active Comparator | Patients with a positive breath test are treated with antibiotics. |
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| Positive SeHCAT scan | Active Comparator | Patients with a positive SeHCAT scan are treated with a bile acid binder. |
|
| No intervention | No Intervention | Patients with a normal breath test and a normal SeHCAT scan receive no intervention. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Antibiotics | Drug | Ciprofloxacin or Rifaximin for 10 days. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Change in SeHCAT retention after 7 days. | The diagnosis of bile acid malabsorption in cases vs. controls is determined by a positive SeHCAT scan. | The SeHCAT scan consists of a baseline measurement and a measurement after 7 days. |
| Serum concentration of FGF19 | The serum value of FGF19 is measured by a blood sample. | Through study completion, an average of 1 month. |
| Measure | Description | Time Frame |
|---|---|---|
| Presence of bacteria in the small bowel | The diagnosis of bacterial overgrowth in the small bowel is determined by a breath test. | Through study completion, an average of 1 month. |
| Symptom relief after treatment with antibiotics or bile acid binder |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Søren Laurberg, MD DMSc | Department of Surgery, Aarhus University Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Hepatology and Gastroenterology, Aarhus University Hospital | Aarhus | 8200 | Denmark |
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| ID | Term |
|---|---|
| D003110 | Colonic Neoplasms |
| D003967 | Diarrhea |
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
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| ID | Term |
|---|---|
| D000900 | Anti-Bacterial Agents |
| C037643 | bile acid binding proteins |
| ID | Term |
|---|---|
| D000890 | Anti-Infective Agents |
| D045506 | Therapeutic Uses |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
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| Bile Acid Binder |
| Drug |
Cholestyramine or Colesevelam lifelong. |
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This will be estimated based on self-reported symptoms: A bowel function questionnaire with 30 questions regarding different aspects of bowel function. The patients should state if they have the symptoms daily, 1-6 times per week, less than once a week, or never.
| After 3 months. |
| Quality of life after treatment with antibiotics or bile acid binder | This will be estimated based on self-reported symptoms: the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 version 3.0. A questionnaire with 30 individual questions summing up to form one global health status, five functional subscales, three symptom scales and six single items addressing different aspects of quality of life. The scales range from 0-100 with a higher score representing a higher level of functioning or a higher degree of symptoms, respectively. | After 3 months. |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |