Clinical Trial: Pathophysiology of Diverticular Disease

Study Status: Recruiting
Recruit Status: Unknown status
Study Type: Observational

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

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 disea

Detailed Summary:
Sponsor: Maastricht University Medical Center

Current Primary Outcome: intestinal (luminal and mucosal) microbiota composition [ Time Frame: up to 2 years ]

Original Primary Outcome: intestinal (luminal and mucosal) microbiota composition [ Time Frame: After inclusion ]

Current Secondary Outcome:

  • Expression of tight junction proteins [ Time Frame: up to 2 years ]
  • Intestinal permeability [ Time Frame: up to 2 years ]


Original Secondary Outcome:

  • Expression of tight junction proteins [ Time Frame: After inclusion ]
  • Intestinal permeability [ Time Frame: After inclusion ]


Information By: Maastricht University Medical Center

Dates:
Date Received: December 14, 2011
Date Started: January 2012
Date Completion: October 2014
Last Updated: January 4, 2012
Last Verified: January 2012