Clinical trial NCT05480059: Assessment of Psychological Symptoms and Health Related Quality of Life in Patients With Irritable Bowel Syndrome
Official title: Assessment of Psychological Symptoms and Health Related Quality of Life in Patients With Irritable Bowel Syndrome
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: IBS - Irritable Bowel Syndrome
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2022-07-29
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patient age between 18 - 50 years old, fulfilling Rome IV criteria with normal investigations

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.

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

Primary outcomes:
measure: Psychiatric Co-morbidities and Health-related Quality of life in Patients with Irritable Bowel Syndrome
timeFrame: baseline
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Assiut University
name: Heidi Ramadan
role: STUDY_DIRECTOR
References:
citation: Lacy BE, Patel NK. Rome Criteria and a Diagnostic Approach to Irritable Bowel Syndrome. J Clin Med. 2017 Oct 26;6(11):99. doi: 10.3390/jcm6110099.
citation: 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.
citation: 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.