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The Association Between the Microbiological Environment in Colon and Colorectal Disease

NCT03302715 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1257

Last updated 2019-10-04

No results posted yet for this study

Summary

Colorectal illness contributes significantly to the global burden of disease. Cancer, inflammatory bowel disease and diverticulosis result in substantial patients suffering and health care expenditures. The causes of colorectal diseases remain unclear.

New data suggests that intestinal bacteria may play a major role in the causal chain for many diseases, and the research on the microbial environment in the colon in relation to bowel disease is increasingly intense although the possibility for analysis of the composition of bacteria in the gut has so far been limited. However, new analytic methods based on powerful DNA sequencing, opens new opportunities.

In the surgical clinic at Danderyds hospital, Stockholm, 2500 colonoscopies are performed per year. The investigators have created a biobank with mucosal samples from patient's large bowel and will consecutively include all patients scheduled for colonoscopy during one year (N=2500). Biopsies from the colonic mucosa will be analysed in collaboration with the Clinical Genomics, Science for Life laboratory (Karolinska Institutet).

In Phase 1, the association between specific bacteria and colorectal disease will be investigated (hypothesis generating phase). In Phase 2, the investigators aim to identify specific bacterial biomarkers that could be used as screening tools, and lay the ground for future new treatments for colorectal disease.

Early detection and new treatment regimes would result in both significant patient benefits as well as reductions in healthcare costs.

Conditions

  • Microbial Colonization and Colorectal Disease

Interventions

GENETIC

Mucosal tissue sampling

Mucosal tissue sampling for DNA analysis

Sponsors & Collaborators

Principal Investigators

  • Erik Näslund, Professor · Department of Surgery, Ersta Hospital, & Department of Clinical Sciences, Danderyd Hospital, Karolinska Institutet, Stockholm, Sweden

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-12-01
Primary Completion
2019-07-01
Completion
2019-07-01

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03302715 on ClinicalTrials.gov