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Psychoemotional Status and Functional Gastrointestinal Disorders

NCT07539051 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 150

Last updated 2026-04-20

No results posted yet for this study

Summary

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.

Conditions

  • Functional Dyspepsia
  • Irritable Bowel Syndrome

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.

Sponsors & Collaborators

  • Center of New Medical Technologies

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-05-01
Primary Completion
2028-05-01
Completion
2028-05-01

Countries

  • Russia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07539051 on ClinicalTrials.gov