Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 3:02 PM
Ignite Modification Date:
2025-12-24 @ 3:02 PM
NCT ID:
NCT05480059
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:
NCT05480059
Study Brief:
Protocol Section:
NCT05480059