Psychoemotional Status and Functional Gastrointestinal Disorders

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorCenter of New Medical Technologies

About this trial

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.

Eligibility criteria

Qualifiers

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

Disqualifiers

Age younger than 18 years

Clinical presentation not meeting Rome IV criteria

Inflammatory bowel disease

Pregnancy or lactation

Trial design

Treatments tested in this trial

  • Questionnaire and Symptom Assessment
  • Helicobacter pylori Status Assessment

Treatment groups

150 Participants
are divided into 2 treatment groups

Locations

1
Center of New Medical Technologies630090, NovosibirskNovosibirsk Oblast, Russia

Sponsors and collaborators

Center of New Medical Technologies

Lead sponsor