NCT04003181

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
64

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 28, 2017

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

April 23, 2019

Completed
2 months until next milestone

First Posted

Study publicly available on registry

July 1, 2019

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 26, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 26, 2021

Completed
Last Updated

September 8, 2021

Status Verified

August 1, 2021

Enrollment Period

3.7 years

First QC Date

April 23, 2019

Last Update Submit

August 31, 2021

Conditions

Colon AdenocarcinomaDiarrhea

Keywords

Bile acid malabsorptionSmall intestinal bacterial overgrowth

Outcome Measures

Primary Outcomes (2)

  • 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.

Secondary Outcomes (3)

  • Presence of bacteria in the small bowel

    Through study completion, an average of 1 month.

  • Symptom relief after treatment with antibiotics or bile acid binder

    After 3 months.

  • Quality of life after treatment with antibiotics or bile acid binder

    After 3 months.

Study Arms (3)

Positive breath test

ACTIVE COMPARATOR

Patients with a positive breath test are treated with antibiotics.

Drug: Antibiotics

Positive SeHCAT scan

ACTIVE COMPARATOR

Patients with a positive SeHCAT scan are treated with a bile acid binder.

Drug: Bile Acid Binder

No intervention

NO INTERVENTION

Patients with a normal breath test and a normal SeHCAT scan receive no intervention.

Interventions

AntibioticsDRUG

Ciprofloxacin or Rifaximin for 10 days.

Positive breath test
Bile Acid BinderDRUG

Cholestyramine or Colesevelam lifelong.

Positive SeHCAT scan

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Hepatology and Gastroenterology, Aarhus University Hospital

Aarhus, 8200, Denmark

Location

MeSH Terms

Conditions

Colonic NeoplasmsDiarrhea

Interventions

Anti-Bacterial Agentsbile acid binding proteins

Condition Hierarchy (Ancestors)

Colorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesSigns and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anti-Infective AgentsTherapeutic UsesPharmacologic ActionsChemical Actions and Uses

Study Officials

  • Søren Laurberg, MD DMSc

    Department of Surgery, Aarhus University Hospital

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 23, 2019

First Posted

July 1, 2019

Study Start

September 28, 2017

Primary Completion

May 26, 2021

Study Completion

May 26, 2021

Last Updated

September 8, 2021

Record last verified: 2021-08

Locations

DK(1)