Assessment of Psychological Symptoms and Health Related Quality of Life in Patients With Irritable Bowel Syndrome

NCT05480059 | Unknown

• 1 other identifier: Irritable bowel syndrome
• Study Type: observational
• Target: 80
• Locations: 0 countries
• Sites: N/A

Brief Summary

To evaluate the relation between the clinical presentations and the psychiatric co-morbidities with the quality of life in patients with irritable bowel syndrome.

Conditions

IBS - Irritable Bowel Syndrome

Outcome Measures

Primary Outcomes (1)

• Psychiatric Co-morbidities and Health-related Quality of life in Patients with Irritable Bowel Syndrome

  A Questionnaire-based Assessment of the Psychiatric Co-morbidities and Health-related Quality of life in Patients with Irritable Bowel Syndrome

  baseline

Interventions

A questionnaire OTHER

A Questionnaire-based Assessment of the Psychiatric Co-morbidities and Health-related Quality of life in Patients with Irritable Bowel Syndrome

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Patient age between 18 - 50 years old, fulfilling Rome IV criteria with normal investigations

You may qualify if:

• Patient age between 18 - 50 years old 2- Patients fulfilling Rome IV criteria with normal investigations such as CBC, ESR , liver and kidney function and \\ or colonoscopy 3- Healthy control: who do not fulfil Rome IV criteria with normal investigations

You may not qualify if:

• Those older than 50 years of age with recent onset of symptoms (less than 6 months).
• Organic causes of colonic symptom. 3- Patients with IBS who have alarm signs. 4- Those with coexisting diseases (e.g. intestinal parasites, malignancy, diabetes mellitus cardiovascular pulmonary, hepatic, or renal disorder).
• Those with a family history of colorectal cancer. 6- IBS in children (\< 18 years) and IBD-IBS patients

Sponsors & Collaborators

• Assiut University: lead

Related Publications (3)

• Lacy BE, Patel NK. Rome Criteria and a Diagnostic Approach to Irritable Bowel Syndrome. J Clin Med. 2017 Oct 26;6(11):99. doi: 10.3390/jcm6110099.

  PMID: 29072609 BACKGROUND

• Kibune Nagasako C, Garcia Montes C, Silva Lorena SL, Mesquita MA. Irritable bowel syndrome subtypes: Clinical and psychological features, body mass index and comorbidities. Rev Esp Enferm Dig. 2016 Feb;108(2):59-64. doi: 10.17235/reed.2015.3979/2015.

  PMID: 26838486 BACKGROUND

• Lee OY. Prevalence and risk factors of irritable bowel syndrome in Asia. J Neurogastroenterol Motil. 2010 Jan;16(1):5-7. doi: 10.5056/jnm.2010.16.1.5. Epub 2010 Jan 31. No abstract available.

  PMID: 20535320 BACKGROUND

MeSH Terms

Conditions

Irritable Bowel Syndrome

Condition Hierarchy (Ancestors)

Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Study Officials

• Heidi Ramadan

  Assiut University

  STUDY DIRECTOR

Central Study Contacts

Ahmed Elhussiny

CONTACT

01157104164; ahmedelhosieny298@gmail.com

Ahlam Farghaly

CONTACT

01221729540; Ahlamgastro2000@yahoo.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Ahmed Elhussiny

Study Record Dates

• First Submitted: July 28, 2022
• First Posted: July 29, 2022
• Study Start: August 1, 2022
• Primary Completion: August 1, 2023
• Study Completion: November 1, 2023
• Last Updated: July 29, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share