Liver CirrhosisNCT01081236
Intestinal Barrier Function and Liver Cirrhosis
An observational study of Liver Cirrhosis, run by Maastricht University Medical Center at 1 site in Netherlands.
Trial summary
Patients with liver cirrhosis have an increased risk to develop life-threatening complications such as spontaneous bacterial peritonitis (SBP). Impairment in the intestinal barrier, changes in numbers and composition of the intestinal microbiota and alterations in immune defenses have been suggested to be involved in… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Liver Cirrhosis
- How many people
- 62 participants
- Where
- 1 siteNetherlands
- Study dates
- May 2010to May 2012
- 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: The study population will be selected from a hospital providing both secondary and tertiary care
Who may be able to join
- Liver cirrhosis of any cause
- A score of greater-than or equal to 5 assessed according to the Child-Pugh classification
- Age between 18 and 65 years
Who cannot join
- Known gastrointestinal diseases (such as inflammatory bowel disease and celiac disease), chronic renal disease (i.e. a glomerular filtration rate of less-than or equal to 60 ml/min per 173 m2 estimated from the Modification of Diet in Renal Disease (MDRD) equation) or Diabetes Mellitus
- Major abdominal surgery interfering with gastrointestinal function (except for uncomplicated appendectomy, cholecystectomy and hysterectomy, other surgery upon judgement of the principle investigator)
Trial locations and contacts
1 site in 1 country.
Netherlands1 site, 1 recruiting
- Recruiting
Maastricht University Medical Center
Maastricht, Limburg
Kirsten Pijls, MD, 0031433882157, k.pijls@maastrichtuniversity.nl
Ad Masclee, MD PhD
About this study
Official title: The Role of the Intestinal Barrier Function in Liver Cirrhosis
Patients with liver cirrhosis have an increased risk to develop life-threatening complications such as spontaneous bacterial peritonitis (SBP). Impairment in the intestinal barrier, changes in numbers and composition of the intestinal microbiota and alterations in immune defenses have been suggested to be involved in liver cirrhosis and its complications. Dysfunction in the intestinal barrier for example results in the ongoing passage of toxic substances from the gastrointestinal tract that may damage the liver, leading to oxidative stress, inflammation and eventually liver cirrhosis. In addition, bacterial translocation is considered a key step in the development of spontaneous infections, mainly SBP, in patients with liver cirrhosis.
The investigators hypothesize that patients with decompensated liver cirrhosis have a more impaired intestinal epithelial barrier and altered intestinal microbiota than patients with compensated liver cirrhosis.
- Conditions
- Liver Cirrhosis
- Keywords
- liver cirrhosis, intestinal permeability, microbiota, complications
- Medical subject headings
- Liver Cirrhosis
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 |
|---|---|---|
| Compensated liver cirrhosis | Not described | |
| Decompensated liver cirrhosis | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary aim is to study differences in small and large intestinal permeability between patients with compensated and decompensated cirrhosis by means of a sugar permeability test
Measured: 2 years
Secondary outcomes (1)
To assess tight junction structure and proteins in biopsy specimens of small and large intestine
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2010 (estimated)
- Study startMay 2010
- Primary completionMay 2012 (estimated)
- Study completionMay 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver CirrhosisStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 62 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Maastricht University Medical Center
- Sponsor type
- University, hospital or other
- Investigators
- A Masclee, MD, PhD, Principal investigator, Maastricht University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01081236
- Sponsor's protocol ID
- MEC 09-2-125
- Status last verified
- Dec 2010
- First submitted
- 4 Mar 2010
- Last updated
- 16 Dec 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of the Intestinal Barrier Function in Liver Cirrhosis
- ClinicalTrials.gov ID
- NCT01081236
- Acronym / sponsor ID
- MEC 09-2-125
- Conditions
- Liver Cirrhosis
- Keywords
- liver cirrhosis, intestinal permeability, microbiota, complications
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 62 participants (estimated)
- Lead sponsor
- Maastricht University Medical CenterUniversity, hospital or other
- Study start
- May 2010
- Primary completion
- May 2012 (estimated)
- Study completion
- May 2012 (estimated)
- First posted
- 5 Mar 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.
Patients with liver cirrhosis have an increased risk to develop life-threatening complications such as spontaneous bacterial peritonitis (SBP). Impairment in the intestinal barrier, changes in numbers and composition of the intestinal microbiota and alterations in immune defenses have been suggested to be involved in liver cirrhosis and its complications. Dysfunction in the intestinal barrier for example results in the ongoing passage of toxic substances from the gastrointestinal tract that may damage the liver, leading to oxidative stress, inflammation and eventually liver cirrhosis. In addition, bacterial translocation is considered a key step in the development of spontaneous infections, mainly SBP, in patients with liver cirrhosis.
The investigators hypothesize that patients with decompensated liver cirrhosis have a more impaired intestinal epithelial barrier and altered intestinal microbiota than patients with compensated liver cirrhosis.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Compensated liver cirrhosis | – | – |
| Decompensated liver cirrhosis | – | – |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population will be selected from a hospital providing both secondary and tertiary care
Key inclusion criteria (3 listed)
- Liver cirrhosis of any cause
- A score of greater-than or equal to 5 assessed according to the Child-Pugh classification
- Age between 18 and 65 years
Key exclusion criteria (2 listed)
- Known gastrointestinal diseases (such as inflammatory bowel disease and celiac disease), chronic renal disease (i.e. a glomerular filtration rate of less-than or equal to 60 ml/min per 173 m2 estimated from the Modification of Diet in Renal Disease (MDRD) equation) or Diabetes Mellitus
- Major abdominal surgery interfering with gastrointestinal function (except for uncomplicated appendectomy, cholecystectomy and hysterectomy, other surgery upon judgement of the principle investigator)
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
The primary aim is to study differences in small and large intestinal permeability between patients with compensated and decompensated cirrhosis by means of a sugar permeability test
Time frame: 2 years
1 secondary outcome
To assess tight junction structure and proteins in biopsy specimens of small and large intestine
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2010.
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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, 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 Liver Cirrhosis, 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 3 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 16 Dec 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 Kirsten Pijls, MD (+31433882157, k.pijls@intmed.unimaas.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The primary aim is to study differences in small and large intestinal permeability between patients with compensated and decompensated cirrhosis by means of a sugar permeability test (time frame: 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 16 Dec 2010.