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

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

Study Overview

• Status: Not yet recruiting
• Conditions: IBS - Irritable Bowel Syndrome
• Intervention / Treatment: Other: A questionnaire

Detailed Description

IBS is a chronic functional disorder characterized by abdominal pain and altered bowel habit in the absence of a specific and unique organic pathology.

Rome IV criteria is used to diagnose IBS patients which depends on the presence of recurrent abdominal pain on average at least 1 day per week in the last 3 months associated with 2 or more of the following; related to defecation, associated with change in frequency of stool , associated with change in stool form. These criteria should be fulfilled for the last 3 months with symptom onset at least 6 months before diagnosis.]1.[ brian et al 2017)[ IBS sub-types include 4 sub-types described according to the dominant stool pattern diarrhea (IBS -D) , constipation (IBS- C) , mixed ( IBS-M) , unspecified( IBS-U) subtypes . ] [2 Cristiane Kibune Nagasako et al 2016 [ The Identified Risk factors for IBS include female sex , younger age , psychological stress during or before infectious gastroenteritis , and the severity of enteritis. [3 ] Oh Young Lee et al 2010

IBS is a painful condition associated with significant psychological distress and psychiatric comorbidities such as higher levels of anxiety or depression and suicidal ideation, with a negative impact on quality of life [4 ] .Canavan et al., 2014; Stasiet al., 2014).

Major psychiatric disorders seen in patients were GAD and MDE. GAD was seen in 30.0% of patients having IBS while MDE was present in 28.0% [5]

Therefore, IBS consequences are measured in direct costs; medical treatment and procedures or indirect costs such as reduced productivit and low quality of life.[6] Doshi et al., 2014a However, few studies were conducted to evaluate the impact of clinical presentations or psychiatric co-morbidities with the quality of life in IBS.

• Study Type: Observational
• Enrollment (Anticipated): 80

Contacts and Locations

• Study Contact: Name: Ahmed Elhussiny; Phone Number: 01157104164; Email: ahmedelhosieny298@gmail.com
• Study Contact Backup: Name: Ahlam Farghaly; Phone Number: 01221729540; Email: Ahlamgastro2000@yahoo.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 46 years (Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

• 1- 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

Exclusion Criteria:

• 1- Those older than 50 years of age with recent onset of symptoms (less than 6 months).

  2- 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).

  5- Those with a family history of colorectal cancer. 6- IBS in children (< 18 years) and IBD-IBS patients

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Assiut University
• Investigators: Study Director: Heidi Ramadan, Assiut University

Publications and helpful links

General Publications

• Lacy BE, Patel NK. Rome Criteria and a Diagnostic Approach to Irritable Bowel Syndrome. J Clin Med. 2017 Oct 26;6(11). pii: E99. doi: 10.3390/jcm6110099. Review.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Anticipated): August 1, 2022
• Primary Completion (Anticipated): August 1, 2023
• Study Completion (Anticipated): November 1, 2023

Study Registration Dates

• First Submitted: July 28, 2022
• First Submitted That Met QC Criteria: July 28, 2022
• First Posted (Actual): July 29, 2022

Study Record Updates

• Last Update Posted (Actual): July 29, 2022
• Last Update Submitted That Met QC Criteria: July 28, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Disease; Gastrointestinal Diseases; Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Syndrome; Irritable Bowel Syndrome
• Other Study ID Numbers: Irritable bowel syndrome

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No