Assessment of the Influence of Psychoemotional Status on the Clinical Course of Functional Disorders of the Stomach and Intestine
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Quality of Life Assessed by SF-36
研究概览
简要总结
This prospective cohort study will evaluate the influence of psychoemotional status on the clinical course and quality of life of adult patients with functional dyspepsia and/or irritable bowel syndrome diagnosed according to Rome IV criteria. The study aims to assess the contribution of affective and somatoform disorders to quality of life and symptom burden in these patients. In participants with functional dyspepsia, the association of Helicobacter pylori status with psychoemotional status and quality of life will also be evaluated. Patients will complete validated questionnaires assessing quality of life, depression, anxiety, and somatization at baseline and again during follow-up after treatment. Clinical symptoms, pain severity, stool characteristics, and H. pylori status will also be assessed as applicable.
详细描述
Detailed Description Functional gastrointestinal disorders are highly prevalent and are currently understood within a biopsychosocial model that includes disturbances in gut-brain interaction. Functional dyspepsia and irritable bowel syndrome are frequently associated with anxiety, depression, and somatization, which may worsen symptom severity and reduce quality of life. This study is designed to evaluate the influence of psychoemotional disturbances on the clinical course of these disorders.
This is a prospective cohort study planned for 2 years and will enroll 150 adult patients with functional dyspepsia and/or irritable bowel syndrome. Eligible participants must be 18 years of age or older, meet Rome IV diagnostic criteria, and provide informed consent. Patients younger than 18 years, those who do not meet Rome IV criteria, and those with inflammatory bowel disease, pregnancy or lactation, malignant neoplasms, or a history of gastrointestinal surgery will not be included. Participants may be withdrawn if they choose to discontinue participation at any stage.
At the baseline visit, after informed consent is obtained, an individual case report form will be completed. Patients will undergo assessment of quality of life using SF-36, psychoemotional status using PHQ-9, GAD-7, and PHQ-15, and pain severity using a visual analogue scale. Patients with irritable bowel syndrome will also complete an assessment of stool form and stool frequency using the Bristol stool scale. In patients with functional dyspepsia, Helicobacter pylori status will be assessed using available laboratory or diagnostic methods, including 13C urea breath test, stool PCR analysis, rapid urease test, or esophagogastroduodenoscopy with biopsy. At the second visit, participants will repeat the questionnaires to assess changes after treatment, and the investigator will evaluate clinical status and adjust treatment if necessary.
The primary outcome measure is quality of life as assessed by SF-36. Secondary outcome measures include changes in PHQ-9, GAD-7, and PHQ-15 scores over time. The study will also explore the relationship between Helicobacter pylori status and psychoemotional status and quality of life in patients with functional dyspepsia.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 years and older
- •Diagnosis of irritable bowel syndrome and/or functional dyspepsia according to Rome IV criteria
- •Written informed consent for participation in the study
排除标准
- •Age younger than 18 years
- •Clinical presentation not meeting Rome IV criteria
- •Inflammatory bowel disease
- •Pregnancy or lactation
- •Malignant neoplasms of any localization
- •History of gastrointestinal surgery
研究组 & 干预措施
Functional Dyspepsia
Adults aged 18 years and older with functional dyspepsia diagnosed according to Rome IV criteria. Participants complete baseline and follow-up assessments of quality of life, psychoemotional status, and pain severity. Helicobacter pylori status is assessed in this cohort.
干预措施: Questionnaire and Symptom Assessment (Diagnostic Test)
Irritable Bowel Syndrome
Adults aged 18 years and older with irritable bowel syndrome diagnosed according to Rome IV criteria. Participants complete baseline and follow-up assessments of quality of life, psychoemotional status, pain severity, and stool characteristics, including Bristol stool scale assessment.
干预措施: Helicobacter pylori Status Assessment (Diagnostic Test)
结局指标
主要结局
Quality of Life Assessed by SF-36
时间窗: 6 months
Quality of life will be assessed using the 36-Item Short Form Health Survey (SF-36). The questionnaire evaluates health-related quality of life across 8 domains, with higher scores indicating better quality of life.
次要结局
- Change in Depression Symptoms Assessed by PHQ-9(6 months)
- Change in Anxiety Symptoms Assessed by GAD-7(6 months)
- Change in Somatization Symptoms Assessed by PHQ-15(6 months)