Irritable Bowel SyndromeNCT01854060
Predictive Factors for a Clinical Diagnosis of Irritable Bowel Syndrome in a Large Cohort of Young Adults.
An observational study of Irritable Bowel Syndrome, run by Medical Corps, Israel Defense Force at 1 site in Israel.
Trial summary
The prevalence of IBS in the community has been reported in numerous cross-sectional surveys. However, less is known about the incidence of IBS ,mainly due to its slow development and to patients under-reporting. Furthermore, only one study has analyzed data concerning potential risk factors for the diagnosis of IBS. Read more about this study
- Who is it for?
- Ages 18 to 39 yearsHealthy volunteers can take part
- Conditions the study is for
- Irritable Bowel Syndrome
- How many people
- 440,822 participants
- Where
- 1 siteIsrael
- Study dates
- Jan 2013to May 2013
- 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 39 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: The study population will consist of Israeli men and women aged 18-39 years who served in active military service (mandatory and career service) between the years 2005-2011
Who may be able to join
- All Israeli men and women
- aged 18-39 years
- served in active military service (mandatory and career service) between the years 2005-2011
Who cannot join
- Diagnosis of celiac disease
- Inflammatory bowel disease
- Cancer in the digestive system
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Predictive Factors for a Clinical Diagnosis of Irritable Bowel Syndrome in a Large Cohort of 440,822 Young Adults.
The prevalence of IBS in the community has been reported in numerous cross-sectional surveys. However, less is known about the incidence of IBS ,mainly due to its slow development and to patients under-reporting. Furthermore, only one study has analyzed data concerning potential risk factors for the diagnosis of IBS. The investigators will examine the incidence of IBS in a large cohort of young adults and will look at the association of socioeconomic, anthropometric and occupational factors with IBS incidence.
- Conditions
- Irritable Bowel Syndrome
- Keywords
- Irritable bowel syndrome, Epidimiology, Deterioration in the severity of irritable bowel syndrome
- 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 |
|---|---|---|
| irritable bowel syndrome | All new cases of clinical diagnosis of irritable bowel syndrome |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of clinical diagnosis of irritable bowel syndrome
New diagnosis of irritable bowel syndrome during this priod
Measured: 6 years
Secondary outcomes (1)
predictive factors for the clinical diagnosis of irritable bowel syndrome
Anthropometric and demographic factors predictive for the clinicaldiagnosis of irritable bowel syndrome including gender, body mass index, ethnicity , type of service
Measured: 6 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2013 (estimated)
- Study startJan 2013
- Primary completionMay 2013
- Study completionMay 2013
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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 440,822 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical Corps, Israel Defense Force
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, DAN CARTER, Medical Corps, Israel Defense Force
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01854060
- Sponsor's protocol ID
- IDF-1083-2011
- Status last verified
- May 2013
- First submitted
- 12 May 2013
- Last updated
- 15 May 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predictive Factors for a Clinical Diagnosis of Irritable Bowel Syndrome in a Large Cohort of 440,822 Young Adults.
- ClinicalTrials.gov ID
- NCT01854060
- Acronym / sponsor ID
- IDF-1083-2011
- Conditions
- Irritable Bowel Syndrome
- Keywords
- Irritable bowel syndrome, Epidimiology, Deterioration in the severity of irritable bowel syndrome
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 440,822 participants (actual)
- Lead sponsor
- Medical Corps, Israel Defense ForceUniversity, hospital or other
- Study start
- Jan 2013
- Primary completion
- May 2013 (actual)
- Study completion
- May 2013 (actual)
- First posted
- 15 May 2013 (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.
The prevalence of IBS in the community has been reported in numerous cross-sectional surveys. However, less is known about the incidence of IBS ,mainly due to its slow development and to patients under-reporting. Furthermore, only one study has analyzed data concerning potential risk factors for the diagnosis of IBS. The investigators will examine the incidence of IBS in a large cohort of young adults and will look at the association of socioeconomic, anthropometric and occupational factors with IBS incidence.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| irritable bowel syndrome | – | –All new cases of clinical diagnosis of irritable bowel syndrome |
Who may qualify
- Ages
- 18 to 39 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- The study population will consist of Israeli men and women aged 18-39 years who served in active military service (mandatory and career service) between the years 2005-2011
Key inclusion criteria (3 listed)
- All Israeli men and women
- aged 18-39 years
- served in active military service (mandatory and career service) between the years 2005-2011
Key exclusion criteria (3 listed)
- Diagnosis of celiac disease
- Inflammatory bowel disease
- Cancer in the digestive system
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
Incidence of clinical diagnosis of irritable bowel syndrome
Time frame: 6 years
New diagnosis of irritable bowel syndrome during this priod
1 secondary outcome
predictive factors for the clinical diagnosis of irritable bowel syndrome
Time frame: 6 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2013.
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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.
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 Irritable Bowel Syndrome, run by Medical Corps, Israel Defense Force at 1 site in Israel.
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 3 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: finished, as of the sponsor's last update on 15 May 2013. 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 Israel. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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.
What does the primary outcome measure?
Incidence of clinical diagnosis of irritable bowel syndrome (time frame: 6 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 15 May 2013; AzTrials last refreshed its copy on 8 Nov 2026.