NCT03178877

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
350

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2016

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2016

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2016

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

June 3, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 7, 2017

Completed
Last Updated

June 7, 2017

Status Verified

June 1, 2017

Enrollment Period

2 months

First QC Date

June 3, 2017

Last Update Submit

June 5, 2017

Conditions

IBS - Irritable Bowel Syndrome

Keywords

IBS, Rome IV criteria, anxiety

Outcome Measures

Primary Outcomes (1)

  • Anxiety and depression

    Anxiety and Depression using Hospital Anxiety Depression Scale

    1 month

Secondary Outcomes (3)

  • Sleep Quality

    1 month

  • Spiritual status

    1 month

  • Academic Stress

    6 months

Study Arms (2)

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

No interventionOTHER
IBSNon IBS

Eligibility Criteria

Age15 Years - 30 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodProbability Sample
Study Population

Medical student from first grade to fifth grade

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cipto Mangunkusumo Hospital

Jakarta Pusat, DKI Jakarta, 10430, Indonesia

Location

MeSH Terms

Conditions

Irritable Bowel SyndromeIchthyosis Bullosa of SiemensAnxiety Disorders

Condition Hierarchy (Ancestors)

Colonic Diseases, FunctionalColonic DiseasesIntestinal DiseasesGastrointestinal DiseasesDigestive System DiseasesIchthyosisSkin AbnormalitiesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesSkin Diseases, GeneticGenetic Diseases, InbornInfant, Newborn, DiseasesKeratosisSkin DiseasesSkin and Connective Tissue DiseasesMental Disorders

Study Design

Study Type
observational
Observational Model
ECOLOGIC OR COMMUNITY
Time Perspective
CROSS SECTIONAL
Target Duration
1 Day
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Medical Doctor, Gastroenterology Hepatology Consultant

Study Record Dates

First Submitted

June 3, 2017

First Posted

June 7, 2017

Study Start

November 1, 2016

Primary Completion

December 31, 2016

Study Completion

December 31, 2016

Last Updated

June 7, 2017

Record last verified: 2017-06

Data Sharing

IPD Sharing
Will not share

Not available to other researcher

Locations

ID(1)