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临床试验/NCT05480059
NCT05480059Unknown不适用

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

Assiut University0 个研究点目标入组 80 人开始时间: 2022年8月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
80
主要终点
Psychiatric Co-morbidities and Health-related Quality of life in Patients with Irritable Bowel Syndrome

研究概览

简要总结

To evaluate the relation between the clinical presentations and the psychiatric co-morbidities with the quality of life in patients with irritable bowel syndrome.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 50 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

结局指标

主要结局

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

时间窗: baseline

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

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ahmed Elhussiny Salah Mahmoud

Ahmed Elhussiny

Assiut University

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