Faculty of MedicineIrritablebowelNCT06097598
Prevalence of Irritable Bowel Syndrome in Medical Students Africa
An observational study of Faculty of Medicine, run by Assiut University.
Trial summary
The aim of the present study was to assess the prevalence of IBS among medical students in the Middle East and North Africa and to investigate the sociodemographic, lifestyle, and clinical factors associated with IBS. Read more about this study
- Who is it for?
- Ages Up to 27 yearsHealthy volunteers can take part
- Conditions the study is for
- Faculty of Medicine
- How many people
- 1,131 participants
- Where
- No sites listed yet
- Study dates
- 20 Oct 2023to 10 Oct 2024
- 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 Up to 27 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: Medical students enrolled in from medical schools located in the Middle East and North Africa.
Who may be able to join
- Medical students enrolled in from medical schools located in the Middle East and North Africa.
Who cannot join
- 1- History of significant comorbidities 2- Participants with definite or suspected history of inflammatory bowel disease, celiac disease, Lactose intolerance or peptic ulcer disease. 3- Psychiatric patients or patients on antidepressant treatment or using psychotropic drugs affecting their cognitive ability.
About this study
Official title: Prevalence of Irritable Bowel Syndrome in Medical Students in the Middle East and North Africa
The aim of the present study was to assess the prevalence of IBS among medical students in the Middle East and North Africa and to investigate the sociodemographic, lifestyle, and clinical factors associated with IBS. A better understanding of IBS correlates is expected to improve our therapeutic approach to IBS in this population.
Read the detailed description
Irritable bowel syndrome (IBS) is a multifactorial chronic disease characterized with functional gastrointestinal disorder which affects the quality of life of the patient. Until now the pathophysiology of IBS was not completely understood but it has been related to multiple mechanisms like: visceral hypersensitivity, Brain-gut axis, post infectious inflammation and genetic abnormalities.(1) Many demographic and environmental factors are considered risk factors for the condition like: sex, age, BMI, social status and life style(2). IBS outspreaded all over the world varying between 14.7% to 16.5% in east Asian countries(3,4). As IBS is diagnosed mainly clinically, many scales have been developed to provide the best sensitivity for diagnosing the condition. The recent common criteria for diagnosing are ROME III and ROME VI. A meta-analysis conducted by Oka et al the pooled prevalence of IBS in 53 surveys that used the Rome III criteria from 38 countries was 9.2% (95% CI 7.6-10.8; I2 = 99.7%). Contrary, the pooled IBS prevalence among the 6 surveys that used the Rome IV criteria from 34 countries was 3.8% (95% CI 3.1-4.5; I2 = 96.6%)(5). The different prevalence rates are probably justified by the multifactorial nature of the disease and the various social status and environments from a country to another. However, there wasn't enough studies could define the prevalence of IBS among middle-eastern countries. The prevalence of IBS varies depending on socioeconomic factors, sex, and age. University students in the Middle East and North Africa are affected by many Lifestyle factors that participate in IBS by one way or another such as unhealthy eating habits (junk or fast food), cigarette smoking, physical inactivity and the fact that they're living low-income countries. IBS has also been associated with psychological factors such as stress, depression, and anxiety. Additionally, as their young age genetic factors and positive family history are implicated. Medical students, are more likely exposed to IBS risk factors as they have limited access to healthy meals, financial constraints, and a excessive exposure to stress secondary to their exceedingly demanding education and frequent examinations. Thus, they are more probably to develop IBS than other population subgroups.
- Conditions
- Faculty of Medicine
What is being measured
The primary outcome is the main question the study is designed to answer.
Describe the prevalence of IBS among medical students
assess the prevalence of IBS among medical students in the Middle East and North Africa and to investigate the sociodemographic,
Page 3 of
lifestyle, and clinical factors associated with IBS. A better understanding of IBS correlates is expected to improve our therapeutic approach to IBS in this population.
Measured: 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2023
- Study start20 Oct 2023 (estimated)
- Primary completion10 Mar 2024 (estimated)
- Study completion10 Oct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Faculty of MedicineStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 1,131 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Collaborators
- AsyutUniversity
- Responsible party
- Principal investigator, Zeinab Galal Eldeen Abdelhamid, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06097598
- Sponsor's protocol ID
- Irritable
- Acronym
- Irritablebowel
- Status last verified
- Oct 2023
- First submitted
- 19 Oct 2023
- Last updated
- 24 Oct 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Camilleri M. Peripheral mechanisms in irritable bowel syndrome. N Engl J Med. 2012 Oct 25;367(17):1626-35. doi: 10.1056/NEJMra1207068. No abstract available.
PubMed 23094724Black CJ, Ford AC. Global burden of irritable bowel syndrome: trends, predictions and risk factors. Nat Rev Gastroenterol Hepatol. 2020 Aug;17(8):473-486. doi: 10.1038/s41575-020-0286-8. Epub 2020 Apr 15.
PubMed 32296140Seger S, Nasharuddin NNB, Fernandez SL, Yunus SRBM, Shun NTM, Agarwal P, Burud I. Prevalence and factors associated with irritable bowel syndrome among medical students in a Malaysian private university: a cross sectional study. Pan Afr Med J. 2020 Oct 13;37:151. doi: 10.11604/pamj.2020.37.151.21716. eCollection 2020.
PubMed 33425184Basandra S, Bajaj D. Epidemiology of Dyspepsia and Irritable Bowel Syndrome (IBS) in Medical Students of Northern India. J Clin Diagn Res. 2014 Dec;8(12):JC13-6. doi: 10.7860/JCDR/2014/10710.5318. Epub 2014 Dec 5.
PubMed 25653974Oka P, Parr H, Barberio B, Black CJ, Savarino EV, Ford AC. Global prevalence of irritable bowel syndrome according to Rome III or IV criteria: a systematic review and meta-analysis. Lancet Gastroenterol Hepatol. 2020 Oct;5(10):908-917. doi: 10.1016/S2468-1253(20)30217-X. Epub 2020 Jul 20.
PubMed 32702295
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence of Irritable Bowel Syndrome in Medical Students in the Middle East and North Africa
- ClinicalTrials.gov ID
- NCT06097598
- Acronym / sponsor ID
- Irritablebowel / Irritable
- Conditions
- Faculty of Medicine
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,131 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Collaborators
- AsyutUniversity
- Study start
- 20 Oct 2023 (estimated)
- Primary completion
- 10 Mar 2024 (estimated)
- Study completion
- 10 Oct 2024 (estimated)
- First posted
- 24 Oct 2023 (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.
The aim of the present study was to assess the prevalence of IBS among medical students in the Middle East and North Africa and to investigate the sociodemographic, lifestyle, and clinical factors associated with IBS. A better understanding of IBS correlates is expected to improve our therapeutic approach to IBS in this population.
Detailed description
Irritable bowel syndrome (IBS) is a multifactorial chronic disease characterized with functional gastrointestinal disorder which affects the quality of life of the patient. Until now the pathophysiology of IBS was not completely understood but it has been related to multiple mechanisms like: visceral hypersensitivity, Brain-gut axis, post infectious inflammation and genetic abnormalities.(1) Many demographic and environmental factors are considered risk factors for the condition like: sex, age, BMI, social status and life style(2). IBS outspreaded all over the world varying between 14.7% to 16.5% in east Asian countries(3,4). As IBS is diagnosed mainly clinically, many scales have been developed to provide the best sensitivity for diagnosing the condition. The recent common criteria for diagnosing are ROME III and ROME VI. A meta-analysis conducted by Oka et al the pooled prevalence of IBS in 53 surveys that used the Rome III criteria from 38 countries was 9.2% (95% CI 7.6-10.8; I2 = 99.7%). Contrary, the pooled IBS prevalence among the 6 surveys that used the Rome IV criteria from 34 countries was 3.8% (95% CI 3.1-4.5; I2 = 96.6%)(5). The different prevalence rates are probably justified by the multifactorial nature of the disease and the various social status and environments from a country to another. However, there wasn't enough studies could define the prevalence of IBS among middle-eastern countries. The prevalence of IBS varies depending on socioeconomic factors, sex, and age. University students in the Middle East and North Africa are affected by many Lifestyle factors that participate in IBS by one way or another such as unhealthy eating habits (junk or fast food), cigarette smoking, physical inactivity and the fact that they're living low-income countries. IBS has also been associated with psychological factors such as stress, depression, and anxiety. Additionally, as their young age genetic factors and positive family history are implicated. Medical students, are more likely exposed to IBS risk factors as they have limited access to healthy meals, financial constraints, and a excessive exposure to stress secondary to their exceedingly demanding education and frequent examinations. Thus, they are more probably to develop IBS than other population subgroups.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- Up to 27 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Medical students enrolled in from medical schools located in the Middle East and North Africa.
Key inclusion criteria (1 listed)
- Medical students enrolled in from medical schools located in the Middle East and North Africa.
Key exclusion criteria (1 listed)
- 1- History of significant comorbidities 2- Participants with definite or suspected history of inflammatory bowel disease, celiac disease, Lactose intolerance or peptic ulcer disease. 3- Psychiatric patients or patients on antidepressant treatment or using psychotropic drugs affecting their cognitive ability.
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
Describe the prevalence of IBS among medical students
Time frame: 6 month
assess the prevalence of IBS among medical students in the Middle East and North Africa and to investigate the sociodemographic, Page 3 of lifestyle, and clinical factors associated with IBS. A better understanding of IBS correlates is expected to improve our therapeutic approach to IBS in this population.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Oct 2023.
- Background: PubMed 23094724Camilleri M. Peripheral mechanisms in irritable bowel syndrome. N Engl J Med. 2012 Oct 25;367(17):1626-35. doi: 10.1056/NEJMra1207068. No abstract available.
- Background: PubMed 32296140Black CJ, Ford AC. Global burden of irritable bowel syndrome: trends, predictions and risk factors. Nat Rev Gastroenterol Hepatol. 2020 Aug;17(8):473-486. doi: 10.1038/s41575-020-0286-8. Epub 2020 Apr 15.
- Background: PubMed 33425184Seger S, Nasharuddin NNB, Fernandez SL, Yunus SRBM, Shun NTM, Agarwal P, Burud I. Prevalence and factors associated with irritable bowel syndrome among medical students in a Malaysian private university: a cross sectional study. Pan Afr Med J. 2020 Oct 13;37:151. doi: 10.11604/pamj.2020.37.151.21716. eCollection 2020.
- Background: PubMed 25653974Basandra S, Bajaj D. Epidemiology of Dyspepsia and Irritable Bowel Syndrome (IBS) in Medical Students of Northern India. J Clin Diagn Res. 2014 Dec;8(12):JC13-6. doi: 10.7860/JCDR/2014/10710.5318. Epub 2014 Dec 5.
- Background: PubMed 32702295Oka P, Parr H, Barberio B, Black CJ, Savarino EV, Ford AC. Global prevalence of irritable bowel syndrome according to Rome III or IV criteria: a systematic review and meta-analysis. Lancet Gastroenterol Hepatol. 2020 Oct;5(10):908-917. doi: 10.1016/S2468-1253(20)30217-X. Epub 2020 Jul 20.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Faculty of Medicine, run by Assiut University.
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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 24 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
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?
Describe the prevalence of IBS among medical students (time frame: 6 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06097598, which also lists 5 linked publications.
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 24 Oct 2023.