Irritable Bowel SyndromeNCT01060527
Altered Faecal Protease Activity in Irritable Bowel Syndrome Patients in China
An observational study of Irritable Bowel Syndrome, run by Xi'an Jiaotong University.
Trial summary
Irritable bowel syndrome (IBS) is a functional gastrointestinal disorder haracterised by abdominal pain or discomfort associated with altered bowel habits,while the mechanism is still not understood.Recent advances have conceptualized the faecal supernatants of diarrhoea-predominant IBS have a substantially higher… Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Irritable Bowel Syndrome
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- Jan 2010to not given
- 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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Outpatients in the second affiliated hospital of xi'an jiaotong university
Who may be able to join
- Patients fulfilling the Rome III criteria for IBS participated in the study -
Who cannot join
- Organic gastrointestinal disorders were excluded by detailed blood and stool analyses, serological assays and colonoscopy.
About this study
Irritable bowel syndrome (IBS) is a functional gastrointestinal disorder haracterised by abdominal pain or discomfort associated with altered bowel habits,while the mechanism is still not understood.Recent advances have conceptualized the faecal supernatants of diarrhoea-predominant IBS have a substantially higher serine protease activity, while in china,almost no studies have reported about protease activity in IBS.
- Conditions
- Irritable Bowel Syndrome
- Keywords
- irritable bowel syndrome,protease activity,China
- Medical subject headings
- Irritable Bowel Syndrome
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 |
|---|---|---|
| IBS-D | Not described | |
| IBS-C | Not described | |
| Controll | Not described |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2010 (estimated)
- Study startJan 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Irritable Bowel SyndromeStudies 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
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xi'an Jiaotong University
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01060527
- Sponsor's protocol ID
- xi'an JTU091202
- Status last verified
- Jan 2010
- First submitted
- 1 Feb 2010
- Last updated
- 2 Feb 2010
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Altered Faecal Protease Activity in Irritable Bowel Syndrome Patients in China
- ClinicalTrials.gov ID
- NCT01060527
- Acronym / sponsor ID
- xi'an JTU091202
- Conditions
- Irritable Bowel Syndrome
- Keywords
- irritable bowel syndrome,protease activity,China
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Xi'an Jiaotong UniversityUniversity, hospital or other
- Study start
- Jan 2010
- First posted
- 2 Feb 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.
Irritable bowel syndrome (IBS) is a functional gastrointestinal disorder haracterised by abdominal pain or discomfort associated with altered bowel habits,while the mechanism is still not understood.Recent advances have conceptualized the faecal supernatants of diarrhoea-predominant IBS have a substantially higher serine protease activity, while in china,almost no studies have reported about protease activity in IBS.
Study design
- Observational model
- Case-control
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| IBS-D | – | – |
| IBS-C | – | – |
| Controll | – | – |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Outpatients in the second affiliated hospital of xi'an jiaotong university
Key inclusion criteria (1 listed)
- Patients fulfilling the Rome III criteria for IBS participated in the study -
Key exclusion criteria (1 listed)
- Organic gastrointestinal disorders were excluded by detailed blood and stool analyses, serological assays and colonoscopy.
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
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Irritable Bowel Syndrome, run by Xi'an Jiaotong University.
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 1 inclusion and 1 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 2 Feb 2010. Status can change between updates, so confirm with the study contact before making plans.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
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 2 Feb 2010.