Psychoemotional Status and Functional Gastrointestinal Disorders
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Questionnaire and Symptom Assessment, Helicobacter pylori Status Assessment.
- Who it may be relevant to
- Registry conditions: Functional Dyspepsia, Irritable Bowel Syndrome. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Russia
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Assessment of the Influence of Psychoemotional Status on the Clinical Course of Functional Disorders of the Stomach and Intestine
Overview
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.
Detailed description
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.
Interventions
- Diagnostic test Questionnaire and Symptom Assessment
Assessment includes SF-36, PHQ-9, GAD-7, PHQ-15, visual analogue scale for pain, and Bristol stool scale as applicable. - Diagnostic test Helicobacter pylori Status Assessment
Helicobacter pylori status in participants with functional dyspepsia is assessed using available laboratory or diagnostic methods, including 13C urea breath test, stool PCR analysis, rapid urease test, or esophagogastroduodenoscopy with biopsy, as applicable.
Primary outcome measures
- Quality of Life Assessed by SF-36 [Time frame: 6 months]
Secondary outcome measures (3)
- Change in Depression Symptoms Assessed by PHQ-9 [Time frame: 6 months]
- Change in Anxiety Symptoms Assessed by GAD-7 [Time frame: 6 months]
- Change in Somatization Symptoms Assessed by PHQ-15 [Time frame: 6 months]
Eligibility criteria
Inclusion criteria
- 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
Exclusion criteria
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Russia · 1 center
- Center of New Medical Technologies — Novosibirsk
Identifiers
NCT: NCT07539051 · CNMT005