Health TrialsbyHealthPanel

Psychoemotional Status and Functional Gastrointestinal Disorders

ConditionsFunctional DyspepsiaIrritable Bowel Syndrome
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

This trial does not accept healthy volunteers

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 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.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • 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.

  • 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.

Treatment groups

150 Participants
are divided into 2 treatment groups
Group A: Functional Dyspepsia1 intervention
Group B: Irritable Bowel Syndrome1 intervention

Trial outcomes

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.

Time frame
6 months

Secondary outcomes

1

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.

Time frame
6 months
2

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.

Time frame
6 months
3

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.

Time frame
6 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Center of New Medical Technologies

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: