PouchitisNCT01202396
The Interaction Between Intestinal Microbiota, Innate Defense and Epithelial Integrity in the Development of Pouchitis
An observational study of Pouchitis, run by Maastricht University Medical Center at 1 site in Netherlands.
Trial summary
Pouchitis is a common complication following proctocolectomy with ileal pouch anal anastomosis (IPAA) in patients with ulcerative colitis (UC). It affects the quality of life and can become a chronic problem. The aetiology of pouchitis is not completely understood. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Pouchitis
- How many people
- 30 participants
- Where
- 1 siteNetherlands
- Study dates
- Nov 2010to Nov 2015
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Consecutive patients undergoing proctocolectomy with the construction of an ileal pouch anal anastomosis will be asked to participate in the study
Who may be able to join
- patients with ulcerative colitis undergoing a total colectomy with IPAA for steroid dependent disease, therapy-refractory disease, colorectal cancer or severe dysplasia
- 18-65 years of age
Who cannot join
- unable to give informed consent
- pregnant or breastfeeding
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Maastricht University Medical Center, div. Gastroenterology-Hepatology
Maastricht, Limburg, 6226AZ
D. Jonkers, PhD, *31-43-3875021, d.jonkers@intmed.unimaas.nl
M. Pierik, PhD MD, *31-43-3875021, m.pierik@mumc.nl
About this study
Official title: The Interaction Between the Intestinal Microbiota, Innate Defense and Epithelial Integrity in the Development of Pouchitis: a Multifactorial Approach
Pouchitis is a common complication following proctocolectomy with ileal pouch anal anastomosis (IPAA) in patients with ulcerative colitis (UC). It affects the quality of life and can become a chronic problem. The aetiology of pouchitis is not completely understood. A crucial role of the intestinal microbiota has been suggested, but no causative agent has been identified so far. Furthermore, the defensin expression and the epithelial integrity are altered in inflammatory bowel diseases and may play an important role in the development of intestinal inflammation. Therefore, it has been hypothesized that the interaction between an altered microbiota composition, a defective epithelial integrity and changes in innate defense parameters such as defensins has a pivotal role in the development of pouchitis in UC patients.
- Conditions
- Pouchitis
- Keywords
- pouch, pouchitis, ulcerative colitis, microbiota, defensins, epithelial integrity
- Medical subject headings
- Pouchitis, Colitis, Ulcerative
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 |
|---|---|---|
| ulcerative colitis patients with a pouch | * ulcerative colitis patients undergoing proctocolectomy with an ileal pouch anal anastomosis * comparing patients with versus those without pouchitis * no intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Differences in the intestinal microbiota composition between pouch patients with and without pouchitis
A phylogenetic microarray will be used to characterize the luminal and mucosal microbiota composition (based on the SSU rRNA gene)of pouch patients with and without pouchitis. Anticipated results are the identification of specific bacterial profiles, genera and/or species dat are discriminating between subgroups.
Measured: 24 months.
Secondary outcomes (4)
The expression of defensins in the intestinal mucosa
The mRNA expression levels of human alfa and beta-defensins in intestinal mucosal biopsies will be assessed by real time PCR
Measured: 24 months
The intestinal permeability
The epithelial integrity will be studied by the multiple sugar test to assess small intestinal and whole gut permeability.
Measured: 24 months.
Inflammatory mediators
Cytokine levels will be studied in serum and in intestinal biopsies. Furthermore, a histological evaluation and the MPO activity will be studied in these biopsies and calprotectin levels will be determined in 'fecal' sampels.
Measured: 24 months
The expression of tight-junction associated proteins
The intestinal tight junctions-associated proteins will be studied by immune staining of intestinal biopsies and mRNA levels in intestinal biopsies using real time PCR. Biopsies will be collected from standardised locations.
Measured: 24 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2010 (estimated)
- Study startNov 2010
- Primary completionNov 2014 (estimated)
- Study completionNov 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PouchitisStudies 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
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Maastricht University Medical Center
- Sponsor type
- University, hospital or other
- Investigators
- A. Masclee, Prof MD PhD, Principal investigator, Maastricht University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01202396
- Sponsor's protocol ID
- MEC-10-2-033
- Status last verified
- Sep 2010
- First submitted
- 2 Sep 2010
- Last updated
- 15 Sep 2010
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Interaction Between the Intestinal Microbiota, Innate Defense and Epithelial Integrity in the Development of Pouchitis: a Multifactorial Approach
- ClinicalTrials.gov ID
- NCT01202396
- Acronym / sponsor ID
- MEC-10-2-033
- Conditions
- Pouchitis
- Keywords
- pouch, pouchitis, ulcerative colitis, microbiota, defensins, epithelial integrity
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Maastricht University Medical CenterUniversity, hospital or other
- Study start
- Nov 2010
- Primary completion
- Nov 2014 (estimated)
- Study completion
- Nov 2015 (estimated)
- First posted
- 15 Sep 2010 (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.
Pouchitis is a common complication following proctocolectomy with ileal pouch anal anastomosis (IPAA) in patients with ulcerative colitis (UC). It affects the quality of life and can become a chronic problem. The aetiology of pouchitis is not completely understood. A crucial role of the intestinal microbiota has been suggested, but no causative agent has been identified so far. Furthermore, the defensin expression and the epithelial integrity are altered in inflammatory bowel diseases and may play an important role in the development of intestinal inflammation. Therefore, it has been hypothesized that the interaction between an altered microbiota composition, a defective epithelial integrity and changes in innate defense parameters such as defensins has a pivotal role in the development of pouchitis in UC patients.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ulcerative colitis patients with a pouch | – | –* ulcerative colitis patients undergoing proctocolectomy with an ileal pouch anal anastomosis * comparing patients with versus those without pouchitis * no intervention |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Consecutive patients undergoing proctocolectomy with the construction of an ileal pouch anal anastomosis will be asked to participate in the study
Key inclusion criteria (2 listed)
- patients with ulcerative colitis undergoing a total colectomy with IPAA for steroid dependent disease, therapy-refractory disease, colorectal cancer or severe dysplasia
- 18-65 years of age
Key exclusion criteria (2 listed)
- unable to give informed consent
- pregnant or breastfeeding
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
Differences in the intestinal microbiota composition between pouch patients with and without pouchitis
Time frame: 24 months.
A phylogenetic microarray will be used to characterize the luminal and mucosal microbiota composition (based on the SSU rRNA gene)of pouch patients with and without pouchitis. Anticipated results are the identification of specific bacterial profiles, genera and/or species dat are discriminating between subgroups.
4 secondary outcomes
The expression of defensins in the intestinal mucosa
Time frame: 24 months
The intestinal permeability
Time frame: 24 months.
Inflammatory mediators
Time frame: 24 months
The expression of tight-junction associated proteins
Time frame: 24 months.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2010.
Related trials for Pouchitis
Active, not recruitingPhase 4
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Rifaximin for the Secondary Prevention of Recurrent Pouchitis
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Oral Aeromonas sp. MTB Phage Therapy for Pouchitis in Patients With Ulcerative Colitis (UC)
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Etrasimod as Prevention of Pouchitis
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Emerging Indications for Hyperbaric Oxygen Treatment
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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. Masclee, Prof MD PhD principal investigator
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 Pouchitis, 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 2 inclusion and 2 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 15 Sep 2010. 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 D. Jonkers, PhD (*31-43-3875021, d.jonkers@intmed.unimaas.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Differences in the intestinal microbiota composition between pouch patients with and without pouchitis (time frame: 24 months.). 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 15 Sep 2010.