Predictive Factors for a Clinical Diagnosis of Irritable... | NCT01854060

Studies
Predictive Factors for a Clinical Diagnosis of Irritable Bowel Syndrome in a Large Cohort of Young Adults.

NCT01854060

Sponsor

Medical Corps, Israel Defense Force

Status

Completed

Last Update Posted

May 15, 2013Estimated

Enrollment

440,822Actual

Phase

Not provided

Conditions

Irritable Bowel Syndrome

Interventions

Not provided

Countries

Israel

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

Annotation Module

Unposted Annotation

Unposted Responsible Party

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2013

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2013

Primary Completion Date

May 2013Actual

Completion Date

May 2013Actual

First Submitted Date

May 12, 2013

First Submission Date that Met QC Criteria

May 14, 2013

First Posted Date

May 15, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 14, 2013

Last Update Posted Date

May 15, 2013Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

DAN CARTER, Head of Gastro Service, Medical Corps, Israel Defense ForcePrincipal Investigator

Lead Sponsor

Medical Corps, Israel Defense ForceOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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. 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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

440,822Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
irritable bowel syndrome		All new cases of clinical diagnosis of irritable bowel syndrome

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Incidence of clinical diagnosis of irritable bowel syndrome	New diagnosis of irritable bowel syndrome during this priod	6 years

Secondary Outcomes

Measure	Description	Time Frame
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	6 years

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

All Israeli men and women
aged 18-39 years
served in active military service (mandatory and career service) between the years 2005-2011

Exclusion Criteria:

Diagnosis of celiac disease
Inflammatory bowel disease
Cancer in the digestive system

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

39 Years

Standard Ages

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Israel Defence Forces, Medical Corps		Ramat Gan		53261	Israel

Type	Date	Date Unknown
Release	Jan 11, 2016
Reset	Feb 8, 2016

Release Date	Unrelease Date	Unrelease Date Unknown	Reset Date	MCP Release Number
Jan 11, 2016			Feb 8, 2016

Condition Browse Module

MeSH Terms

ID	Term
D043183	Irritable Bowel Syndrome

Ancestor Terms

ID	Term
D003109	Colonic Diseases, Functional
D003108	Colonic Diseases
D007410	Intestinal Diseases
D005767	Gastrointestinal Diseases

Browse Leaves

Not provided

Browse Branches

Not provided