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

• Conditions: IBS - Irritable Bowel Syndrome

• Registration Number: NCT05480059
• Lead Sponsor: Assiut University

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.

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 Timeline

• Status Verified: 2022-07
• Study First Submitted: 2022-07-28
• Study First Submitted QC: 2022-07-28
• Last Update Submitted: 2022-07-28
• Study First Posted: 2022-07-29
• Last Update Posted: 2022-07-29
• Study Start: 2022-08-01
• Primary Completion: 2023-08-01
• Study Completion: 2023-11-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 80

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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