Functional DyspepsiaNCT07539051
Psychoemotional Status and Functional Gastrointestinal Disorders
An observational study of Functional Dyspepsia and Irritable Bowel Syndrome, run by Center of New Medical Technologies at 1 site in Russia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Functional Dyspepsia, Irritable Bowel Syndrome
- What is being tested?
- Questionnaire and Symptom Assessment and Helicobacter pylori Status Assessment
- Type of treatment
- Injection or infusion
- How many people
- 150 participants
- Where
- 1 siteRussia
- Study dates
- 1 May 2026to 1 May 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Russia1 site
Center of New Medical Technologies
Novosibirsk, Novosibirsk Oblast, 630090
Andrei V Ponomarenko, MD, 9628316017 ext. +7, dayshadoff@gmail.com
About this study
Official title: 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.
Read the 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.
- Conditions
- Functional Dyspepsia, Irritable Bowel Syndrome
- Being tested
- Questionnaire and Symptom Assessment, Helicobacter pylori Status Assessment
- Keywords
- Psychoemotional Status, Quality of Life, Anxiety, Depression, Somatization, PHQ-9, GAD-7, PHQ-15, SF-36, Helicobacter pylori, Rome IV, Gut-Brain Interaction
- Medical subject headings
- Irritable Bowel Syndrome, Anxiety Disorders, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Questionnaire and Symptom AssessmentDiagnostic 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 AssessmentDiagnostic 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Diagnostic Test: Helicobacter pylori Status Assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months
Secondary outcomes (3)
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.
Measured: 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.
Measured: 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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2026
- Study start1 May 2026 (estimated)
- Primary completion1 May 2028 (estimated)
- Study completion1 May 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Functional DyspepsiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Center of New Medical Technologies
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07539051
- Sponsor's protocol ID
- CNMT005
- Status last verified
- Apr 2026
- First submitted
- 7 Apr 2026
- Last updated
- 20 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of the Influence of Psychoemotional Status on the Clinical Course of Functional Disorders of the Stomach and Intestine
- ClinicalTrials.gov ID
- NCT07539051
- Acronym / sponsor ID
- CNMT005
- Conditions
- Functional Dyspepsia, Irritable Bowel Syndrome
- Keywords
- Psychoemotional Status, Quality of Life, Anxiety, Depression, Somatization, PHQ-9, GAD-7, PHQ-15
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Center of New Medical TechnologiesUniversity, hospital or other
- Study start
- 1 May 2026 (estimated)
- Primary completion
- 1 May 2028 (estimated)
- Study completion
- 1 May 2028 (estimated)
- First posted
- 20 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Functional Dyspepsia | – | Diagnostic Test: Questionnaire and Symptom AssessmentAdults 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. |
| Irritable Bowel Syndrome | – | Diagnostic Test: Helicobacter pylori Status AssessmentAdults 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (6 listed)
- Age younger than 18 years
- Clinical presentation not meeting Rome IV criteria
- Inflammatory bowel disease
- Pregnancy or lactation
- Malignant neoplasms of any localization
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Questionnaire and Symptom AssessmentAssessment includes SF-36, PHQ-9, GAD-7, PHQ-15, visual analogue scale for pain, and Bristol stool scale as applicable. | Diagnostic test | Functional Dyspepsia |
| Helicobacter pylori Status AssessmentHelicobacter 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. | Diagnostic test | Irritable Bowel Syndrome |
Primary outcome
Quality of Life Assessed by SF-36
Time frame: 6 months
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.
3 secondary outcomes
Change in Depression Symptoms Assessed by PHQ-9
Time frame: 6 months
Change in Anxiety Symptoms Assessed by GAD-7
Time frame: 6 months
Change in Somatization Symptoms Assessed by PHQ-15
Time frame: 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Functional Dyspepsia and Irritable Bowel Syndrome, run by Center of New Medical Technologies at 1 site in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 20 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Evgeniya V Shrainer, PhD (983 300 22 05 ext. +7, shrayner_ev@cnmt.ru), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of Life Assessed by SF-36 (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Apr 2026.