Clinical trial NCT05340400: The Prevalence and Risk Factors of Irritable Bowel Syndrome Among Adults
Official title: The Prevalence and Risk Factors of Irritable Bowel Syndrome Among Adults: A Multi-Centre Cross-sectional Study.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Irritable Bowel Syndrome
Colonic Diseases, Functional
Keywords: Rome IV criteria
Colonic Diseases
Digestive System Diseases
Irritable Bowel Syndrome
Lead sponsor: University of Aleppo
Sponsor class: OTHER
First posted: 2022-04-22
Enrollment: 5500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Community sample.

Brief summary: This is a multicenter cross-sectional study on the prevalence of Irritable Bowel Syndrome and the risk factors associated with it. The Rome IV criteria is used for diagnosing IBS. A questionnaire-guided interview will be applied to all subjects.

Detailed description: : Irritable Bowel Syndrome (IBS) is a common functional bowel disorder characterized by abdominal pain or discomfort associated with defecation or an altered bowel habit. IBS can be divided into four subtypes according to the predominant bowel pattern: diarrhea-predominant (IBS-D), constipation-predominant (IBS-C), and both diarrhea and constipation (IBS-M), and when a stool pattern cannot be categorized under any of the above three patterns (IBS-U).

For clinicians, diagnosis of IBS can be challenging because symptoms can be variable over time, and what makes it a real challenge is the absence of a gold diagnostic standard for this syndrome. That is why experts developed the Rome criteria in 2006, which is constantly revised. The latest update of these criteria was published in 2016 as Rome IV.

Unfortunately, studies have indicated higher rates of psychological comorbidity including suicidal ideation and depression among IBS patients, and a significant reduction in health-related quality of life, this negatively affects the productivity of the individual in society. Epidemiological studies of this syndrome have indicated a greater prevalence among women than men, and adolescents among other age groups.

However, despite these attempts by researchers to determine the prevalence patterns and risk factors for this syndrome, many of them are still not sufficiently defined. Hence, our study came to determine the prevalence and risk factors of Irritable Bowel Syndrome among adults.

Eligibility criteria: Inclusion Criteria:

* Volunteer to participate in the study

Exclusion Criteria:

* Poorly-controlled hyperthyroidism
* Poorly-controlled hypothyroidism
* Poorly-controlled hyperparathyroidism
* Liver disease
* Paralysis
* Parasitic diseases (worms ...)
* Celiac disease
* Inflammatory bowel disease (Crohn's disease or Ulcerative colitis)
* Lactose intolerance
* Cancer or tumor in the digestive tract

Primary outcomes:
measure: The Prevalence of Irritable Bowel Syndrome
timeFrame: 30 days
Secondary outcomes:
measure: Physical activity as risk factor for IBS
timeFrame: 30 days
measure: Perceived Stress Scale as risk factor for IBS
timeFrame: 30 days
measure: Fatigue as risk factor for IBS
timeFrame: 30 days
measure: Diet and weight questions as risk factor for IBS
timeFrame: 30 days
measure: Habits as risk factor for IBS
timeFrame: 30 days
Other outcomes:
Locations:
city: Aleppo
country: Syrian Arab Republic
facility: Ahmad Yamen Arnaout
city: Aleppo
country: Syrian Arab Republic
facility: University of Aleppo
Study officials:
References:
citation: Mearin F, Lacy BE, Chang L, Chey WD, Lembo AJ, Simren M, Spiller R. Bowel Disorders. Gastroenterology. 2016 Feb 18:S0016-5085(16)00222-5. doi: 10.1053/j.gastro.2016.02.031. Online ahead of print.
citation: Longstreth GF, Thompson WG, Chey WD, Houghton LA, Mearin F, Spiller RC. Functional bowel disorders. Gastroenterology. 2006 Apr;130(5):1480-91. doi: 10.1053/j.gastro.2005.11.061.
citation: Drossman DA, Morris CB, Hu Y, Toner BB, Diamant N, Leserman J, Shetzline M, Dalton C, Bangdiwala SI. A prospective assessment of bowel habit in irritable bowel syndrome in women: defining an alternator. Gastroenterology. 2005 Mar;128(3):580-9. doi: 10.1053/j.gastro.2004.12.006.
citation: Palsson OS, Baggish JS, Turner MJ, Whitehead WE. IBS patients show frequent fluctuations between loose/watery and hard/lumpy stools: implications for treatment. Am J Gastroenterol. 2012 Feb;107(2):286-95. doi: 10.1038/ajg.2011.358. Epub 2011 Nov 8.
citation: Zamani M, Alizadeh-Tabari S, Zamani V. Systematic review with meta-analysis: the prevalence of anxiety and depression in patients with irritable bowel syndrome. Aliment Pharmacol Ther. 2019 Jul;50(2):132-143. doi: 10.1111/apt.15325. Epub 2019 Jun 3.
citation: Gralnek IM, Hays RD, Kilbourne A, Naliboff B, Mayer EA. The impact of irritable bowel syndrome on health-related quality of life. Gastroenterology. 2000 Sep;119(3):654-60. doi: 10.1053/gast.2000.16484.