The Prevalence of Irritable Bowel Syndrome Using Rome IV... | NCT03178877

Studies
The Prevalence of Irritable Bowel Syndrome Using Rome IV Criteria in Medical Student and The Related Factors

NCT03178877

Sponsor

Indonesia University

Status

Completed

Last Update Posted

Jun 7, 2017Actual

Enrollment

350Actual

Phase

Not provided

Conditions

IBS - Irritable Bowel Syndrome

Interventions

No intervention

Countries

Indonesia

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

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2017

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

Nov 1, 2016Actual

Primary Completion Date

Dec 31, 2016Actual

Completion Date

Dec 31, 2016Actual

First Submitted Date

Jun 3, 2017

First Submission Date that Met QC Criteria

Jun 5, 2017

First Posted Date

Jun 7, 2017Actual

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

Jun 5, 2017

Last Update Posted Date

Jun 7, 2017Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Ari Fahrial Syam, Medical Doctor, Gastroenterology Hepatology Consultant, Indonesia UniversityPrincipal Investigator

Lead Sponsor

Indonesia UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

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

Detailed Description

A cross-sectional study of 350 medical student Universitas Indonesia from first grade until fifth grade was done during November-December 2016. This study used stratified randomized sampling. The Rome IV criteria was used for diagnosing IBS. Questionnaire-guided interview was applied to all subjects. A bivariate analysis was done to know the relationship between IBS and its related factors using chi-square, unpaired t-test, and their alternatives. Multivariate analysis was done using logistic regression test

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

1 Day

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

350Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
IBS		IBS group is medical student who filled Rome IV criteria for IBS	Other: No intervention
Non IBS		Non-IBS group is non IBS medical student based on Rome IV criteria	Other: No intervention

Interventions

Name	Type	Description	Arm Group Labels	Other Names
No intervention	Other		IBS Non IBS

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Anxiety and depression	Anxiety and Depression using Hospital Anxiety Depression Scale	1 month

Secondary Outcomes

Measure	Description	Time Frame
Sleep Quality	Sleep quality using Pittsburg Sleep Quality Index	1 month
Spiritual status	Spiritual status using Functional Assessment of Chronic Illness Therapy-Spiritual Wellbeing

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age of participant >= 15 years
Volunteer to participate in study

Exclusion Criteria:

Red flag symptoms: febrile, vomiting, rectal bleeding, weight lost
Diagnosed as having Inflammatory bowel disease
Peptic ulcer drug consumption
History of gastrointestinal surgery

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

15 Years

Maximum Age

30 Years

Standard Ages

ChildAdult

Study Population

Medical student from first grade to fifth grade

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Cipto Mangunkusumo Hospital		Jakarta Pusat	DKI Jakarta	10430	Indonesia

IPD Sharing Statement Module

Plan to Share IPD

Description

Not available to other researcher

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D043183	Irritable Bowel Syndrome
D053560	Ichthyosis Bullosa of Siemens
D001008	Anxiety Disorders

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