NCT05340400

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
5,500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2022

Shorter than P25 for all trials

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 15, 2022

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 22, 2022

Completed
3 days until next milestone

Study Start

First participant enrolled

April 25, 2022

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 25, 2022

Completed
16 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 10, 2022

Completed
Last Updated

June 14, 2022

Status Verified

June 1, 2022

Enrollment Period

1 month

First QC Date

April 15, 2022

Last Update Submit

June 11, 2022

Conditions

Keywords

Rome IV criteriaColonic DiseasesDigestive System DiseasesIrritable Bowel Syndrome

Outcome Measures

Primary Outcomes (1)

  • The Prevalence of Irritable Bowel Syndrome

    Collaborators will make an interview questions using ROME IV to diagnose IBS among adults.

    30 days

Secondary Outcomes (5)

  • Physical activity as risk factor for IBS

    30 days

  • Perceived Stress Scale as risk factor for IBS

    30 days

  • Fatigue as risk factor for IBS

    30 days

  • Diet and weight questions as risk factor for IBS

    30 days

  • Habits as risk factor for IBS

    30 days

Study Arms (2)

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

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

Interventions

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 diagnosed with IBSPatients not diagnosed with IBS

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Community sample.

You may qualify if:

  • Volunteer to participate in the study

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Ahmad Yamen Arnaout

Aleppo, Syria

Location

University of Aleppo

Aleppo, Syria

Location

Related Publications (7)

  • 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.

    PMID: 27144627BACKGROUND
  • 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.

    PMID: 16678561BACKGROUND
  • 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.

    PMID: 15765393BACKGROUND
  • 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.

    PMID: 22068664BACKGROUND
  • 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.

    PMID: 31157418BACKGROUND
  • 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.

    PMID: 10982758BACKGROUND
  • Arnaout AY, Nerabani Y, Douba Z, Kassem LH, Arnaout K, Shabouk MB, Zayat H, Mayo W, Bezo Y, Arnaout I, Yousef A, Zeina MB, Aljarad Z; PRIBS Study Team. The prevalence and risk factors of irritable bowel syndrome (PRIBS study) among adults in low- and middle-income countries: A multicenter cross-sectional study. Health Sci Rep. 2023 Oct 4;6(10):e1592. doi: 10.1002/hsr2.1592. eCollection 2023 Oct.

MeSH Terms

Conditions

Irritable Bowel SyndromeColonic Diseases, FunctionalColonic DiseasesDigestive System Diseases

Condition Hierarchy (Ancestors)

Intestinal DiseasesGastrointestinal Diseases

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

April 15, 2022

First Posted

April 22, 2022

Study Start

April 25, 2022

Primary Completion

May 25, 2022

Study Completion

June 10, 2022

Last Updated

June 14, 2022

Record last verified: 2022-06

Data Sharing

IPD Sharing
Will not share

Not available to other researchers.

Locations