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.
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
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.
- Conditions
- Colonic Diverticula, Diverticulitis
- 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 group | Role | What they receive |
|---|---|---|
| Controls | No diverticular disease or other gastrointestinal and liver diseases | |
| Uncomplicated diverticular disease | Not described | |
| History of complicated diverticular disease | Not described | |
| Current complicated diverticular disease | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
intestinal (luminal and mucosal) microbiota composition
Measured: up to 2 years
Secondary outcomes (2)
Expression of tight junction proteins
Measured: up to 2 years
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.
- First posted16 Dec 2011 (estimated)
- Study startJan 2012
- Primary completionOct 2013 (estimated)
- Study completionOct 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colonic DiverticulaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Maastricht University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- A. M. Masclee, MD, PhD, Principal investigator, Maastricht University Medical CenterD. Jonkers, PhD, Study chair, Maastricht University Medical CenterR. C. Deutz, MD, Study chair, Maastricht University Medical Center
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
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Intestinal Microbiota Composition and Intestinal Permeability in the Development of (Complicated) Diverticular Disease.
- ClinicalTrials.gov ID
- NCT01493349
- Acronym / sponsor ID
- 11-2-058
- Conditions
- Colonic Diverticula, Diverticulitis
- Keywords
- Colonic diverticula, Diverticulitis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 210 participants (estimated)
- Lead sponsor
- Maastricht University Medical CenterUniversity, hospital or other
- Study start
- Jan 2012
- Primary completion
- Oct 2013 (estimated)
- Study completion
- Oct 2014 (estimated)
- First posted
- 16 Dec 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Time perspective
- Cross-sectional
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Controls | – | –No diverticular disease or other gastrointestinal and liver diseases |
| Uncomplicated diverticular disease | – | – |
| History of complicated diverticular disease | – | – |
| Current complicated diverticular disease | – | – |
Who may qualify
- Ages
- 50 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients referred to the hospital by their general practitioner
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
intestinal (luminal and mucosal) microbiota composition
Time frame: up to 2 years
2 secondary outcomes
Expression of tight junction proteins
Time frame: up to 2 years
Intestinal permeability
Time frame: up to 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
A. M. Masclee, MD, PhD principal investigator
Maastricht University Medical Center
D. Jonkers, PhD study chair
Maastricht University Medical Center
R. C. Deutz, MD study chair
Maastricht University Medical Center
1 site in 1 country: see every site and its status.
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.