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Colonic DiverticulaNCT01493349

Pathophysiology of Diverticular Disease

An observational study of Colonic Diverticula and Diverticulitis, run by Maastricht University Medical Center at 1 site in Netherlands.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 50 to 75 years
Conditions the study is for
Colonic Diverticula, Diverticulitis
How many people
210 participants
Where
1 siteNetherlands
Study dates
Jan 2012to Oct 2014
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 50 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Patients referred to the hospital by their general practitioner

Who may be able to join

  • 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.

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Netherlands1 site
  • Maastricht University Medical Center

    Maastricht, Limburg, 6202 AZ

    R. C. Deutz, MD

    A. M. Masclee, MD, PhD

Other trials in Netherlands

About this study

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

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.

Keywords
Colonic diverticula, Diverticulitis
Medical subject headings
Diverticulum, Colon, Diverticulitis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT01493349
Study groupRoleWhat they receive
ControlsNo diverticular disease or other gastrointestinal and liver diseases
Uncomplicated diverticular diseaseNot described
History of complicated diverticular diseaseNot described
Current complicated diverticular diseaseNot described

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. intestinal (luminal and mucosal) microbiota composition

    Measured: up to 2 years

Secondary outcomes (2)
  1. Expression of tight junction proteins

    Measured: up to 2 years

  2. Intestinal permeability

    Measured: up to 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Dec 2011 (estimated)
  2. Study startJan 2012
  3. Primary completionOct 2013 (estimated)
  4. Study completionOct 2014 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Time perspective
Cross-sectional
Enrolment
210 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01493349
Sponsor's protocol ID
11-2-058
Status last verified
Jan 2012
First submitted
14 Dec 2011
Last updated
5 Jan 2012
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

An observational study of Colonic Diverticula and Diverticulitis, run by Maastricht University Medical Center at 1 site in Netherlands.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 5 Jan 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Renske Deutz, MD (1-31-43-3884190, r.deutz@maastrichtuniversity.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

intestinal (luminal and mucosal) microbiota composition (time frame: up to 2 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jan 2012.

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