Irritable Bowel Syndrome Clinical Trial
Official title:
The Prevalence and Risk Factors of Irritable Bowel Syndrome Among Adults: A Multi-Centre Cross-sectional Study.
NCT number | NCT05340400 |
Other study ID # | PRIBS Study |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | April 25, 2022 |
Est. completion date | June 10, 2022 |
Verified date | June 2022 |
Source | University of Aleppo |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 5500 |
Est. completion date | June 10, 2022 |
Est. primary completion date | May 25, 2022 |
Accepts healthy volunteers | |
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 |
Country | Name | City | State |
---|---|---|---|
Syrian Arab Republic | Ahmad Yamen Arnaout | Aleppo | |
Syrian Arab Republic | University of Aleppo | Aleppo |
Lead Sponsor | Collaborator |
---|---|
University of Aleppo |
Syrian Arab Republic,
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
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 |
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