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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

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07539051
Enrollment
150
Registered
2026-04-20
Start date
2026-05-01
Completion date
2028-05-01
Last updated
2026-04-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

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

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.

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.

Interventions

DIAGNOSTIC_TESTQuestionnaire 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_TESTHelicobacter 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

Center of New Medical Technologies
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Quality of Life Assessed by SF-366 monthsQuality 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.

Secondary

MeasureTime frameDescription
Change in Depression Symptoms Assessed by PHQ-96 monthsDepression 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.
Change in Anxiety Symptoms Assessed by GAD-76 monthsAnxiety 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.
Change in Somatization Symptoms Assessed by PHQ-156 monthsSomatization 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.

Countries

Russia

Contacts

CONTACTEvgeniya V Shrainer, PhD
shrayner_ev@cnmt.ru983 300 22 05

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 21, 2026