The Prevalence and Risk Factors of Irritable Bowel Syndrome Among Adults

Irritable Bowel Syndrome Clinical Trial

Official title:

The Prevalence and Risk Factors of Irritable Bowel Syndrome Among Adults: A Multi-Centre Cross-sectional Study.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05340400
• Other study ID #: PRIBS Study
• Status: Completed
• Start date: April 25, 2022
• Est. completion date: June 10, 2022

Study information

• Verified date: June 2022
• Source: University of Aleppo
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 5500
• Est. completion date: June 10, 2022
• Est. primary completion date: May 25, 2022
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Colonic Diseases
• Colonic Diseases, Functional
• Irritable Bowel Syndrome
• Syndrome

Intervention

Other:
• ROME IV Criteria
Collaborators will use Rome IV criteria for diagnosing IBS by the presence of the abdominal pain at least once a week in the last 3 months, in addition to at least two of the following: abdominal pain related to defecation, change in stool frequency, or shape.

Locations

Country	Name	City	State
Syrian Arab Republic	Ahmad Yamen Arnaout	Aleppo
Syrian Arab Republic	University of Aleppo	Aleppo

Sponsors (1)

Lead Sponsor	Collaborator
University of Aleppo

Country where clinical trial is conducted

Syrian Arab Republic, 

References & Publications (6)

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. — View 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. — View Citation

Longstreth GF, Thompson WG, Chey WD, Houghton LA, Mearin F, Spiller RC. Functional bowel disorders. Gastroenterology. 2006 Apr;130(5):1480-91. Review. Erratum in: Gastroenterology. 2006 Aug;131(2):688. — View Citation

Mearin F, Lacy BE, Chang L, Chey WD, Lembo AJ, Simren M, Spiller R. Bowel Disorders. Gastroenterology. 2016 Feb 18. pii: S0016-5085(16)00222-5. doi: 10.1053/j.gastro.2016.02.031. [Epub ahead of print] — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The Prevalence of Irritable Bowel Syndrome	Collaborators will make an interview questions using ROME IV to diagnose IBS among adults.	30 days
Secondary	Physical activity as risk factor for IBS	Collaborators will use the World Health Organization questionnaire to classify the physical activity of the participants into good and poor physical activity.	30 days
Secondary	Perceived Stress Scale as risk factor for IBS	It is the most widely used measure of global perceived stress, and a robust predictor of health and disease. The total score is calculated on the basis of the answers to a series of questions based on monthly stress, and the participant's health status. PSS is a summary measure of ten items (range 0-4 points for every item). It is classified into low (PSS 0-13), moderate (PSS 14-26), and high perceived stress (PSS 27-40).	30 days
Secondary	Fatigue as risk factor for IBS	Fatigue will be measured using the Chalder Fatigue Scale (CFQ), a self-administered questionnaire for measuring the extent and severity of fatigue within both clinical and non-clinical, epidemiological populations. CFQ is a summary measure of eleven items (range 0-33)	30 days
Secondary	Diet and weight questions as risk factor for IBS	Collaborators will use a questionnaire to determine the participant's predominant dietary pattern, feeding patterns and allergies	30 days
Secondary	Habits as risk factor for IBS	Smoking, drinking alcohol, caffeine intake, and sleep pattern.	30 days