The Prevalence and Risk Factors of Irritable Bowel Syndrome Among Adults

Sponsor

University of Aleppo (Other)

Overall Status

Completed

CT.gov ID

NCT05340400

Collaborator

(none)

5,500

Enrollment

Locations

1.5

Actual Duration (Months)

2750

Patients Per Site

1819.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Irritable Bowel Syndrome Colonic Diseases, Functional	Other: ROME IV Criteria

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.

Study Design

Study Type:

Observational

Actual Enrollment :

5500 participants

Observational Model:

Other

Time Perspective:

Cross-Sectional

Official Title:

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

Actual Study Start Date :

Apr 25, 2022

Actual Primary Completion Date :

May 25, 2022

Actual Study Completion Date :

Jun 10, 2022

Arms and Interventions

Arm	Intervention/Treatment
Patients diagnosed with IBS Collaborators will use Rome IV criteria for diagnosing IBS, and then divide participants into those with and without the disease.	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.
Patients not diagnosed with IBS Collaborators will use Rome IV criteria for diagnosing IBS, and then divide participants into those with and without the disease.	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.

Arm

Intervention/Treatment

Patients diagnosed with IBS

Collaborators will use Rome IV criteria for diagnosing IBS, and then divide participants into those with and without the disease.

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.

Patients not diagnosed with IBS

Collaborators will use Rome IV criteria for diagnosing IBS, and then divide participants into those with and without the disease.

Other: ROME IV Criteria

Outcome Measures

Primary Outcome Measures

The Prevalence of Irritable Bowel Syndrome [30 days]
Collaborators will make an interview questions using ROME IV to diagnose IBS among adults.

Secondary Outcome Measures

Physical activity as risk factor for IBS [30 days]
Collaborators will use the World Health Organization questionnaire to classify the physical activity of the participants into good and poor physical activity.
Perceived Stress Scale as risk factor for IBS [30 days]
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).
Fatigue as risk factor for IBS [30 days]
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)
Diet and weight questions as risk factor for IBS [30 days]
Collaborators will use a questionnaire to determine the participant's predominant dietary pattern, feeding patterns and allergies
Habits as risk factor for IBS [30 days]
Smoking, drinking alcohol, caffeine intake, and sleep pattern.