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Pathophysiology of Diverticular Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01493349
Recruitment Status : Unknown
Verified January 2012 by Maastricht University Medical Center.
Recruitment status was:  Not yet recruiting
First Posted : December 16, 2011
Last Update Posted : January 5, 2012
Information provided by (Responsible Party):
Maastricht University Medical Center

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
Colonic Diverticula Diverticulitis

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Study Type : Observational
Estimated 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 : January 2012
Estimated Primary Completion Date : October 2013
Estimated Study Completion Date : October 2014

Resource links provided by the National Library of Medicine

No diverticular disease or other gastrointestinal and liver diseases
Uncomplicated diverticular disease
History of complicated diverticular disease
Current complicated diverticular disease

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

Secondary Outcome Measures :
  1. Expression of tight junction proteins [ Time Frame: up to 2 years ]
  2. Intestinal permeability [ Time Frame: up to 2 years ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients referred to the hospital by their general practitioner

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01493349

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Contact: Renske Deutz, MD 1-31-43-3884190

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Maastricht University Medical Center
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
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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
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Responsible Party: Maastricht University Medical Center Identifier: NCT01493349    
Other Study ID Numbers: 11-2-058
First Posted: December 16, 2011    Key Record Dates
Last Update Posted: January 5, 2012
Last Verified: January 2012
Keywords provided by Maastricht University Medical Center:
Colonic diverticula
Additional relevant MeSH terms:
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Diverticular Diseases
Diverticulum, Colon
Diverticulosis, Colonic
Intraabdominal Infections
Gastrointestinal Diseases
Digestive System Diseases
Pathological Conditions, Anatomical
Colonic Diseases
Intestinal Diseases