Colon AdenocarcinomaNCT04003181
The Pathogenesis of Chronic Diarrhoea After Treatment for Cancer in Cecum and the Ascending Colon
A study testing Antibiotics and Bile Acid Binder in people with Colon Adenocarcinoma and Diarrhea, run by University of Aarhus at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colon Adenocarcinoma, Diarrhea
- What is being tested?
- Antibiotics and Bile Acid Binder
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteDenmark
- Study dates
- 28 Sep 2017to 26 May 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Primary adenocarcinoma in cecum or the ascending colon
- Right-sided hemicolectomy
- Understanding, speaking and reading Danish
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Department of Hepatology and Gastroenterology, Aarhus University Hospital
Aarhus, 8200
About this study
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.
Read more
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.
Read the 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.
- Conditions
- Colon Adenocarcinoma, Diarrhea
- Being tested
- Antibiotics, Bile Acid Binder
- Keywords
- Bile acid malabsorption, Small intestinal bacterial overgrowth
- Medical subject headings
- Colonic Neoplasms, Diarrhea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AntibioticsDrug
Ciprofloxacin or Rifaximin for 10 days.
Bile Acid BinderDrug
Cholestyramine or Colesevelam lifelong.
| Study group | Role | What they receive |
|---|---|---|
| Positive breath test | Active comparator | Patients with a positive breath test are treated with antibiotics. Receives: Drug: Antibiotics |
| Positive SeHCAT scan | Active comparator | Patients with a positive SeHCAT scan are treated with a bile acid binder. Receives: Drug: Bile Acid Binder |
| No intervention | No intervention | Patients with a normal breath test and a normal SeHCAT scan receive no intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in SeHCAT retention after 7 days.
The diagnosis of bile acid malabsorption in cases vs. controls is determined by a positive SeHCAT scan.
Measured: 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.
Measured: Through study completion, an average of 1 month.
Secondary outcomes (3)
Presence of bacteria in the small bowel
The diagnosis of bacterial overgrowth in the small bowel is determined by a breath test.
Measured: Through study completion, an average of 1 month.
Symptom relief after treatment with antibiotics or bile acid binder
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.
Measured: 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.
Measured: After 3 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2019
- Study start28 Sep 2017
- Primary completion26 May 2021
- Study completion26 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colon AdenocarcinomaStudies of the same condition, open and under way.
- More trials run by University of AarhusThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Collaborators
- Danish Cancer Society, GE Healthcare
- Responsible party
- Sponsor
- Investigators
- Søren Laurberg, MD DMSc, Study chair, Department of Surgery, Aarhus University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04003181
- Sponsor's protocol ID
- 1-10-72-301-16
- Other IDs
- 1-16-02-137-17
- Status last verified
- Aug 2021
- First submitted
- 23 Apr 2019
- Last updated
- 8 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Pathogenesis of Chronic Diarrhoea After Treatment for Cancer in Cecum and the Ascending Colon
- ClinicalTrials.gov ID
- NCT04003181
- Acronym / sponsor ID
- 1-10-72-301-16
- Conditions
- Colon Adenocarcinoma, Diarrhea
- Keywords
- Bile acid malabsorption, Small intestinal bacterial overgrowth
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Collaborators
- Danish Cancer Society, GE Healthcare
- Study start
- 28 Sep 2017 (actual)
- Primary completion
- 26 May 2021 (actual)
- Study completion
- 26 May 2021 (actual)
- First posted
- 1 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Positive breath test | Active comparator | Drug: AntibioticsPatients with a positive breath test are treated with antibiotics. |
| Positive SeHCAT scan | Active comparator | Drug: Bile Acid BinderPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Primary adenocarcinoma in cecum or the ascending colon
- Right-sided hemicolectomy
- Understanding, speaking and reading Danish
Key exclusion criteria (7 listed)
- Previous major gastrointestinal, urological or gynaecological surgery or oncological treatment
- Radiation therapy
- Recurrence of colon cancer
- Metastasis
- Permanent stoma
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AntibioticsCiprofloxacin or Rifaximin for 10 days. | Drug | Positive breath test |
| Bile Acid BinderCholestyramine or Colesevelam lifelong. | Drug | Positive SeHCAT scan |
Primary outcome
Change in SeHCAT retention after 7 days.
Time frame: 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.
Serum concentration of FGF19
Time frame: Through study completion, an average of 1 month.
The serum value of FGF19 is measured by a blood sample.
3 secondary outcomes
Presence of bacteria in the small bowel
Time frame: Through study completion, an average of 1 month.
Symptom relief after treatment with antibiotics or bile acid binder
Time frame: After 3 months.
Quality of life after treatment with antibiotics or bile acid binder
Time frame: After 3 months.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Søren Laurberg, MD DMSc study chair
Department of Surgery, Aarhus University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Antibiotics and Bile Acid Binder in people with Colon Adenocarcinoma and Diarrhea, run by University of Aarhus at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in SeHCAT retention after 7 days. (time frame: The SeHCAT scan consists of a baseline measurement and a measurement after 7 days.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2021.