Pathophysiology of Diverticular Disease

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified January 2012 by Maastricht University Medical Center
Sponsor:
Information provided by (Responsible Party):
Maastricht University Medical Center
ClinicalTrials.gov Identifier:
NCT01493349
First received: December 14, 2011
Last updated: January 4, 2012
Last verified: January 2012
  Purpose

Colonic diverticular disease is a highly prevalent condition in Western populations. The prevalence increases age-dependently from 5% at 40 years to 65% by the age of 85 years (1-3). The majority remain asymptomatic. However, a significant proportion of the patient population develops complications, such as diverticulitis with or without symptoms (10-20%) (1, 4-10). Perforated diverticulitis is rare with an estimated incidence of 4 per 100.000 per year, but the associated mortality rate is 22% to 39% (9, 11, 12). In the United States, the complications related to diverticular disease account for 130.000 hospitalizations each year, resulting in substantial health care costs (13). In Europe, it is estimated that approximately 23.600 deaths per year can be attributed to complicated diverticular disease, and the mortality will probably increase in the future due to the aging population (15-17). Several case studies report an overall increase in the incidence of diverticulitis, based on the increase in hospitalizations (18). Kang et al, reported a 16% increased male admission rate and 12% female admission rate for diverticulitis, between 1989/1990 and 1999/2000 (19). Aging and the Western diet, low in fiber and high in fat, in combination with increased intraluminal pressure and alterations in colonic motility are considered important etiological factors. A disturbance in large bowel motility is suggested to be a common pathophysiological feature in IBS and diverticular disease (20, 21). Based on observations that IBD, subgroups of IBS and (symptomatic) diverticular disease share clinical symptoms, the hypothesis is derived that they might also share pathophysiological factors like low grade inflammation, changed microbiota composition and activity, and increased intestinal permeability. The identification of clinical and pathophysiological factors associated with an increased risk for complicated diverticular disease may help to identify patients with diverticular disease, prevent complications, develop strategies to improve quality of life and reduce the related health care costs. Therefore we aim to investigate the composition of luminal and mucosal intestinal microbiota and the intestinal permeability in the development of diverticular disease and complicated diverticular disease. We hypothesize that both the intestinal microbiota and intestinal permeability are altered in patients with (current- or previous history of complicated) diverticular disease.


Condition
Colonic Diverticula
Diverticulitis

Study Type: Observational
Study Design: Time Perspective: Cross-Sectional
Official Title: The Role of Intestinal Microbiota Composition and Intestinal Permeability in the Development of (Complicated) Diverticular Disease.

Resource links provided by NLM:


Further study details as provided by Maastricht University Medical Center:

Primary Outcome Measures:
  • intestinal (luminal and mucosal) microbiota composition [ Time Frame: up to 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Expression of tight junction proteins [ Time Frame: up to 2 years ] [ Designated as safety issue: No ]
  • Intestinal permeability [ Time Frame: up to 2 years ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples Without DNA
  • 1 bloodsample (14.5mL)
  • 9 Colonic mucosal biopsies
  • 1 Intestinal washing sample (at least 15mL)
  • 1 Fecal sample

Estimated Enrollment: 210
Study Start Date: January 2012
Estimated Study Completion Date: October 2014
Estimated Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
Controls
No diverticular disease or other gastrointestinal and liver diseases
Uncomplicated diverticular disease
History of complicated diverticular disease
Current complicated diverticular disease

  Eligibility

Ages Eligible for Study:   50 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients referred to the hospital by their general practitioner

Criteria

Inclusion Criteria:

  • Age ≥ 50 years and ≤ 75 years
  • Scheduled for colonoscopy
  • Written informed consent
  • Patient group: The presence of diverticulosis, diagnosed during the scheduled colonoscopy
  • Control group: During the scheduled colonoscopy, diverticulosis or other
  • gastrointestinal and liver diseases are absent. In other words, the
  • colonoscopy is qualified as a 'normal' colonoscopy.

Exclusion Criteria:

  • Age < 18 years
  • Presence of gastrointestinal and liver diseases, such as inflammatory bowel disease.
  • Use of NSAID's and proton pump inhibitors, during the 5-day time period prior to endoscopy.
  • Alcohol intake above 14 consumptions per week for males and 7 consumption per week for females
  • (Sub)total colectomy or hemicolectomy.
  • Refusal to participate in this study
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01493349

Contacts
Contact: Renske Deutz, MD 1-31-43-3884190 r.deutz@maastrichtuniversity.nl

Locations
Netherlands
Maastricht University Medical Center Not yet recruiting
Maastricht, Limburg, Netherlands, 6202 AZ
Sub-Investigator: R. C. Deutz, MD         
Principal Investigator: A. M. Masclee, MD, PhD         
Sponsors and Collaborators
Maastricht University Medical Center
Investigators
Principal Investigator: A. M. Masclee, MD, PhD Maastricht University Medical Center
Study Chair: D. Jonkers, PhD Maastricht University Medical Center
Study Chair: R. C. Deutz, MD Maastricht University Medical Center
  More Information

No publications provided

Responsible Party: Maastricht University Medical Center
ClinicalTrials.gov Identifier: NCT01493349     History of Changes
Other Study ID Numbers: 11-2-058
Study First Received: December 14, 2011
Last Updated: January 4, 2012
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by Maastricht University Medical Center:
Colonic diverticula
Diverticulitis

Additional relevant MeSH terms:
Diverticulum, Colon
Diverticulitis
Diverticulum
Pathological Conditions, Anatomical
Intraabdominal Infections
Infection
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on August 21, 2014