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Clinical Trials/NCT05480059
NCT05480059
Unknown
N/A

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

Assiut University0 sites80 target enrollmentAugust 1, 2022

Overview

Phase
N/A
Intervention
Not specified
Conditions
IBS - Irritable Bowel Syndrome
Sponsor
Assiut University
Enrollment
80
Primary Endpoint
Psychiatric Co-morbidities and Health-related Quality of life in Patients with Irritable Bowel Syndrome
Last Updated
3 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
August 1, 2022
End Date
November 1, 2023
Last Updated
3 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Ahmed Elhussiny Salah Mahmoud

Ahmed Elhussiny

Assiut University

Eligibility Criteria

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

Outcomes

Primary Outcomes

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

Time Frame: baseline

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

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