Psychoemotional Status and Functional Gastrointestinal Disorders

NCT07539051 | Not Yet Recruiting

• 1 other identifier: CNMT005
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Psychoemotional Status; Quality of Life; Anxiety; Depression; Somatization; PHQ-9; GAD-7; PHQ-15; SF-36; Helicobacter pylori; Rome IV; Gut-Brain Interaction

Outcome Measures

Primary Outcomes (1)

• Quality of Life Assessed by SF-36

  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.

  6 months

Secondary Outcomes (3)

• 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

Study Arms (2)

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.

Diagnostic Test: 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.

Diagnostic Test: Helicobacter pylori Status Assessment

Interventions

Questionnaire and Symptom Assessment DIAGNOSTIC_TEST

Assessment includes SF-36, PHQ-9, GAD-7, PHQ-15, visual analogue scale for pain, and Bristol stool scale as applicable.

Functional Dyspepsia

Helicobacter pylori Status Assessment DIAGNOSTIC_TEST

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.

Irritable Bowel Syndrome

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population consists of adults aged 18 years and older with irritable bowel syndrome and/or functional dyspepsia diagnosed according to Rome IV criteria who present for gastroenterology care at participating CNMT Group study sites in Novosibirsk, Russia.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Center of New Medical Technologies: lead

Study Sites (1)

Center of New Medical Technologies

Novosibirsk, Novosibirsk Oblast, 630090, Russia

Location

MeSH Terms

Conditions

Irritable Bowel Syndrome; Anxiety Disorders; Depression

Interventions

Symptom Assessment

Condition Hierarchy (Ancestors)

Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Mental Disorders; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Diagnostic Techniques and Procedures; Diagnosis

Central Study Contacts

Evgeniya V Shrainer, PhD

CONTACT

983 300 22 05; shrayner_ev@cnmt.ru

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 7, 2026
• First Posted: April 20, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): May 1, 2028
• Study Completion (Estimated): May 1, 2028
• Last Updated: April 20, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

RU (1)