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Irritable Bowel SyndromeNCT05340400

The Prevalence and Risk Factors of Irritable Bowel Syndrome Among Adults

An observational study of Irritable Bowel Syndrome and Colonic Diseases, Functional, run by University of Aleppo at 2 sites in Syria.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
ROME IV Criteria
Type of treatment
Injection or infusion
How many people
5,500 participants
Where
2 sitesSyria
Study dates
25 Apr 2022to 10 Jun 2022
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Adult, Older adult

Study population: Community sample.

Who may be able to join

  • Volunteer to participate in the study

Who cannot join

  • Poorly-controlled hyperthyroidism
  • Poorly-controlled hypothyroidism
  • Poorly-controlled hyperparathyroidism
  • Liver disease
  • Paralysis
  • Parasitic diseases (worms ...)
Show all 10Show fewer
  • Celiac disease
  • Inflammatory bowel disease (Crohn's disease or Ulcerative colitis)
  • Lactose intolerance
  • Cancer or tumor in the digestive tract

Trial locations and contacts

2 sites in 1 country.

Syria2 sites

  • Ahmad Yamen Arnaout

    Aleppo

  • University of Aleppo

    Aleppo

Other trials in Syria

About this study

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

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.

Read the 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.

Being tested
ROME IV Criteria
Keywords
Rome IV criteria, Colonic Diseases, Digestive System Diseases, Irritable Bowel Syndrome
Medical subject headings
Irritable Bowel Syndrome, Colonic Diseases, Functional, Colonic Diseases, Digestive System Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ROME IV CriteriaOther

    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.

Study groups in NCT05340400
Study groupRoleWhat they receive
Patients diagnosed with IBSCollaborators will use Rome IV criteria for diagnosing IBS, and then divide participants into those with and without the disease.
Receives: Other: ROME IV Criteria
Patients not diagnosed with IBSCollaborators will use Rome IV criteria for diagnosing IBS, and then divide participants into those with and without the disease.
Receives: Other: ROME IV Criteria

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The Prevalence of Irritable Bowel Syndrome

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

    Measured: 30 days

Secondary outcomes (5)

  1. 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.

    Measured: 30 days

  2. 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).

    Measured: 30 days

  3. 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)

    Measured: 30 days

  4. 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

    Measured: 30 days

  5. Habits as risk factor for IBS

    Smoking, drinking alcohol, caffeine intake, and sleep pattern.

    Measured: 30 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Apr 2022
  2. Study start25 Apr 2022
  3. Primary completion25 May 2022
  4. Study completion10 Jun 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Other
Time perspective
Cross-sectional
Enrolment
5,500 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05340400
Sponsor's protocol ID
PRIBS Study
Status last verified
Jun 2022
First submitted
15 Apr 2022
Last updated
14 Jun 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Not available to other researchers.

Publications

  • 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.

    PubMed 27144627

  • 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.

    PubMed 16678561

  • 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.

    PubMed 15765393

  • 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.

    PubMed 22068664

  • 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.

    PubMed 31157418

  • 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.

    PubMed 10982758

  • 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.

    PubMed 37808932

Questions about this trial

What is this clinical trial studying?

An observational study of Irritable Bowel Syndrome and Colonic Diseases, Functional, run by University of Aleppo at 2 sites in Syria.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Syria. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The Prevalence of Irritable Bowel Syndrome (time frame: 30 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05340400, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jun 2022.

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