Psychoemotional Status and Functional Gastrointestinal Disorders

Assessment of the Influence of Psychoemotional Status on the Clinical Course of Functional Disorders of the Stomach and Intestine

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Functional Dyspepsia; Irritable Bowel Syndrome
• Intervention / Treatment: Diagnostic test: Questionnaire and Symptom Assessment; Diagnostic test: Helicobacter pylori Status Assessment

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 Participants may be withdrawn if they choose to discontinue participation at any stage.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.

• Study Type: Observational
• Enrollment (Estimated): 150

Contacts and Locations

• Study Contact: Name: Evgeniya V Shrainer, PhD; Phone Number: +7 983 300 22 05; Email: shrayner_ev@cnmt.ru

Study Locations

• Russia
  • Novosibirsk Oblast
    • Novosibirsk, Novosibirsk Oblast, Russia, 630090
      • Center of New Medical Technologies
      • Contact: Andrei V Ponomarenko, MD; Phone Number: +7 9628316017; Email: dayshadoff@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; Assessment includes SF-36, PHQ-9, GAD-7, PHQ-15, visual analogue scale for pain, and Bristol stool scale as applicable.
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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Depression Symptoms Assessed by PHQ-9	Depression symptoms will be assessed using the 9-item Patient Health Questionnaire (PHQ-9). The scale is used to screen for depression and assess its severity over time.	6 months
Change in Anxiety Symptoms Assessed by GAD-7	Anxiety symptoms will be assessed using the 7-item Generalized Anxiety Disorder scale (GAD-7). The scale is used to evaluate the severity of anxiety symptoms and monitor changes during follow-up.	6 months
Change in Somatization Symptoms Assessed by PHQ-15	Somatization symptoms will be assessed using the 15-item Patient Health Questionnaire (PHQ-15). The scale is used to evaluate the presence and severity of somatic symptoms over time.	6 months

Collaborators and Investigators

• Sponsor: Center of New Medical Technologies

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2026
• Primary Completion (Estimated): May 1, 2028
• Study Completion (Estimated): May 1, 2028

Study Registration Dates

• First Submitted: April 7, 2026
• First Submitted That Met QC Criteria: April 13, 2026
• First Posted (Actual): April 20, 2026

Study Record Updates

• Last Update Posted (Actual): April 20, 2026
• Last Update Submitted That Met QC Criteria: April 13, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Depression; Quality of Life; Anxiety; Helicobacter pylori; SF-36; GAD-7; PHQ-15; Somatization; PHQ-9; Rome IV; Psychoemotional Status; Gut-Brain Interaction
• Additional Relevant MeSH Terms: Mental Disorders; Intestinal Diseases; Behavioral Symptoms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Colonic Diseases, Functional; Behavior; Irritable Bowel Syndrome; Anxiety Disorders; Depression; Diagnostic Techniques and Procedures; Diagnosis; Symptom Assessment
• Other Study ID Numbers: CNMT005

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No