Psychoemotional Status and Functional Gastrointestinal Disorders
Key facts
- Who runs it
- Center of New Medical Technologies
- Where
- Russia1 site in 1 countryChoose a country to see its sites
- Trial code
- Status
- Not yet recruiting
- People taking part
- 150 people, planned
- Started
- 1 May 2026
- Expected to end
- 1 May 2028
- Type of study
- Observational, 2 groups
- Treatments tested
- Questionnaire and Symptom Assessment
- Helicobacter pylori Status Assessment
- Record updated
- 20 April 2026
Who can take part
- Age
- 18 years and older
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 9 criteriaShow less
Who can take part
- 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
Who cannot take part
- Inflammatory bowel disease
- Malignant neoplasms of any localization
- History of gastrointestinal surgery
- Age younger than 18 years
- Clinical presentation not meeting Rome IV criteria
- Pregnancy or lactation
This trial has no sites in United States.
It has sites in one country. Choose a country to see its sites.
About the trial
What the trial wants to find out
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.
The 2 groups in the trial
- 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.
Treatment: Questionnaire and Symptom Assessment
- 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.
Treatment: Helicobacter pylori Status Assessment
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Assessment of the Influence of Psychoemotional Status on the Clinical Course of Functional Disorders of the Stomach and Intestine
- Record updated
- 20 April 2026