Pathophysiology of Diverticular Disease

NCT01493349 | Unknown

• 1 other identifier: 11-2-058
• Study Type: observational
• Target: 210
• Locations: 1 country
• Sites: 1

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.

Conditions

Colonic Diverticula; Diverticulitis

Keywords

Colonic diverticula; Diverticulitis

Outcome Measures

Primary Outcomes (1)

• intestinal (luminal and mucosal) microbiota composition

  up to 2 years

Secondary Outcomes (2)

• Expression of tight junction proteins

  up to 2 years

• Intestinal permeability

  up to 2 years

Study Arms (4)

Controls

No diverticular disease or other gastrointestinal and liver diseases

Uncomplicated diverticular disease

History of complicated diverticular disease

Current complicated diverticular disease

Eligibility Criteria

• Age: 50 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients referred to the hospital by their general practitioner

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Maastricht University Medical Center: lead

Study Sites (1)

Maastricht University Medical Center

Maastricht, Limburg, 6202 AZ, Netherlands

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

* 1 bloodsample (14.5mL) * 9 Colonic mucosal biopsies * 1 Intestinal washing sample (at least 15mL) * 1 Fecal sample

MeSH Terms

Conditions

Diverticulum, Colon; Diverticulitis

Condition Hierarchy (Ancestors)

Diverticulum; Diverticular Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• A. M. Masclee, MD, PhD

  Maastricht University Medical Center

  PRINCIPAL INVESTIGATOR

• D. Jonkers, PhD

  Maastricht University Medical Center

  STUDY CHAIR

• R. C. Deutz, MD

  Maastricht University Medical Center

  STUDY CHAIR

Central Study Contacts

Renske Deutz, MD

CONTACT

1-31-43-3884190; r.deutz@maastrichtuniversity.nl

Study Design

• Study Type: observational
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 14, 2011
• First Posted: December 16, 2011
• Study Start: January 1, 2012
• Primary Completion: October 1, 2013
• Study Completion: October 1, 2014
• Last Updated: January 5, 2012

Record last verified: 2012-01

Locations

NL (1)