IBS - Irritable Bowel SyndromeIBSNCT03178877
The Prevalence of Irritable Bowel Syndrome Using Rome IV Criteria in Medical Student and The Related Factors
An observational study of IBS - Irritable Bowel Syndrome, run by Universitas Indonesia at 1 site in Indonesia.
Trial 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. Read more about this study
- Who is it for?
- Ages 15 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- IBS - Irritable Bowel Syndrome
- Type of treatment
- Injection or infusion
- How many people
- 350 participants
- Where
- 1 siteIndonesia
- Study dates
- 1 Nov 2016to 31 Dec 2016
- How long will I take part?
- 1 Day
- 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 15 to 30 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: Medical student from first grade to fifth grade
Who may be able to join
- Age of participant >= 15 years
- Volunteer to participate in study
Who cannot join
- Red flag symptoms: febrile, vomiting, rectal bleeding, weight lost
- Diagnosed as having Inflammatory bowel disease
- Peptic ulcer drug consumption
- History of gastrointestinal surgery
Trial locations and contacts
1 site in 1 country.
Indonesia1 site
Cipto Mangunkusumo Hospital
Jakarta Pusat, DKI Jakarta, 10430
About this study
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.
Read the 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
- Conditions
- IBS - Irritable Bowel Syndrome
- Being tested
- No intervention
- Keywords
- IBS, Rome IV criteria, anxiety
- Medical subject headings
- Irritable Bowel Syndrome, Ichthyosis Bullosa of Siemens, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
| Study group | Role | What they receive |
|---|---|---|
| IBS | IBS group is medical student who filled Rome IV criteria for IBS Receives: Other: No intervention | |
| Non IBS | Non-IBS group is non IBS medical student based on Rome IV criteria Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anxiety and depression
Anxiety and Depression using Hospital Anxiety Depression Scale
Measured: 1 month
Secondary outcomes (3)
Sleep Quality
Sleep quality using Pittsburg Sleep Quality Index
Measured: 1 month
Spiritual status
Spiritual status using Functional Assessment of Chronic Illness Therapy-Spiritual Wellbeing
Measured: 1 month
Academic Stress
Academic stress using Student-Life Stress Inventory
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2017
- Study start1 Nov 2016
- Primary completion31 Dec 2016
- Study completion31 Dec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for IBS - Irritable Bowel SyndromeStudies of the same condition, open and under way.
- More trials run by Universitas IndonesiaThe sponsor's other registered studies.
- 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
- Ecologic or community
- Time perspective
- Cross-sectional
- Enrolment
- 350 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Universitas Indonesia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ari Fahrial Syam, Universitas Indonesia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03178877
- Sponsor's protocol ID
- 16-11-430
- Acronym
- IBS
- Status last verified
- Jun 2017
- First submitted
- 3 Jun 2017
- Last updated
- 7 Jun 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Not available to other researcher
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Prevalence of Irritable Bowel Syndrome Using Rome IV Criteria in Medical Student and The Related Factors
- ClinicalTrials.gov ID
- NCT03178877
- Acronym / sponsor ID
- IBS / 16-11-430
- Conditions
- IBS - Irritable Bowel Syndrome
- Keywords
- IBS, Rome IV criteria, anxiety
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 350 participants (actual)
- Lead sponsor
- Universitas IndonesiaUniversity, hospital or other
- Study start
- 1 Nov 2016 (actual)
- Primary completion
- 31 Dec 2016 (actual)
- Study completion
- 31 Dec 2016 (actual)
- First posted
- 7 Jun 2017 (actual)
- 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.
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.
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
Study design
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Day
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IBS | – | Other: No interventionIBS group is medical student who filled Rome IV criteria for IBS |
| Non IBS | – | Other: No interventionNon-IBS group is non IBS medical student based on Rome IV criteria |
Who may qualify
- Ages
- 15 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Medical student from first grade to fifth grade
Key inclusion criteria (2 listed)
- Age of participant >= 15 years
- Volunteer to participate in study
Key exclusion criteria (4 listed)
- Red flag symptoms: febrile, vomiting, rectal bleeding, weight lost
- Diagnosed as having Inflammatory bowel disease
- Peptic ulcer drug consumption
- History of gastrointestinal surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No intervention | Other | IBS, Non IBS |
Primary outcome
Anxiety and depression
Time frame: 1 month
Anxiety and Depression using Hospital Anxiety Depression Scale
3 secondary outcomes
Sleep Quality
Time frame: 1 month
Spiritual status
Time frame: 1 month
Academic Stress
Time frame: 6 months
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 7 Jun 2017.
- Individual participant dataSharing planned: No. Not available to other researcher
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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 IBS - Irritable Bowel Syndrome, run by Universitas Indonesia at 1 site in Indonesia.
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 2 inclusion and 4 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 7 Jun 2017. 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 Indonesia. 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?
Anxiety and depression (time frame: 1 month). 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 7 Jun 2017.