Ignite Creation Date:
2025-12-24 @ 3:02 PM
Ignite Modification Date:
2025-12-29 @ 6:00 PM
Study NCT ID:
NCT05480059
Status:
UNKNOWN
Last Update Posted:
2022-07-29
First Post:
2022-07-28
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Assessment of Psychological Symptoms and Health Related Quality of Life in Patients With Irritable Bowel Syndrome
Sponsor:
Assiut University
Organization:
Study Overview
Official Title:
Assessment of Psychological Symptoms and Health Related Quality of Life in Patients With Irritable Bowel Syndrome
Status:
UNKNOWN
Status Verified Date:
2022-07
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: