Pathophysiology of Diverticular Disease

Sponsor

Maastricht University Medical Center (Other)

Overall Status

Unknown status

CT.gov ID

NCT01493349

Collaborator

(none)

210

Enrollment

Location

Duration (Months)

6.4

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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 or Disease	Intervention/Treatment	Phase
Colonic Diverticula Diverticulitis

Study Design

Study Type:

Observational

Anticipated Enrollment :

210 participants

Time Perspective:

Cross-Sectional

Official Title:

The Role of Intestinal Microbiota Composition and Intestinal Permeability in the Development of (Complicated) Diverticular Disease.

Study Start Date :

Jan 1, 2012

Anticipated Primary Completion Date :

Oct 1, 2013

Anticipated Study Completion Date :

Oct 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Controls No diverticular disease or other gastrointestinal and liver diseases
Uncomplicated diverticular disease
History of complicated diverticular disease
Current complicated diverticular disease

Outcome Measures

Primary Outcome Measures

intestinal (luminal and mucosal) microbiota composition [up to 2 years]

Secondary Outcome Measures

Expression of tight junction proteins [up to 2 years]
Intestinal permeability [up to 2 years]

Eligibility Criteria

Criteria

Ages Eligible for Study:

50 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	Maastricht University Medical Center	Maastricht	Limburg	Netherlands	6202 AZ

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