Irritable Bowel SyndromeIrBiSNCT06837064
Efficacy of Chatbot for Irritable Bowel Syndrome (IBS) Patients
A study testing Chatbot supporting system in people with Irritable Bowel Syndrome and Irritable Bowel Syndrome - Constipation, run by Research and Practical Clinical Center for Diagnostics and Telemedicine Technologies of the Moscow Health Care Department at 1 site in Russia.
Trial summary
The goal of this clinical trial is to evaluate the efficacy of an automated chatbot system in improving quality of life, reducing depression and anxiety, and decreasing visceral sensitivity in patients with Irritable Bowel Syndrome. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Irritable Bowel Syndrome, Irritable Bowel Syndrome - Constipation, Irritable Bowel Syndrome - Diarrhoea
- What is being tested?
- Chatbot supporting system
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteRussia
- Study dates
- Mar 2025to Aug 2025
- Phase
- Interventional
- 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
Who may be able to join
- Adults ≥18 years;
- Diagnosed with IBS;
- Signed informed consent.
Who cannot join
- Age under 18 years;
- Pregnant individuals;
- Patients with cognitive or sensory impairments that hinder understanding of questions in surveys, scales, or instruments used in the study;
- Patients unable to use a chatbot;
- Patients currently participating in any other clinical trial or experimental study;
- Patients with psychotic symptoms;
- Patients with other conditions that may influence the endpoints of the current study.
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
Research and Practical Clinical Center for Diagnostics and Telemedicine Technologies of the Moscow Health Care Department
Moscow, 127051
About this study
Official title: Evaluation of the Efficacy of Chatbot-based Automated Support System for Patients with Irritable Bowel Syndrome (IBS)
The goal of this clinical trial is to evaluate the efficacy of an automated chatbot system in improving quality of life, reducing depression and anxiety, and decreasing visceral sensitivity in patients with Irritable Bowel Syndrome. The main research question is:
Is an automated chatbot as effective for patients with IBS as standard care? Participants will be asked to complete online surveys to assess quality of life, symptoms of depression and anxiety, and visceral sensitivity before and after the intervention.
Read the detailed description
The study consists of three stages:
Stage 1: Patients with Irritable Bowel Syndrome (IBS) who meet the eligibility criteria will be invited to participate in the study. After providing written informed consent, all participants will be asked to complete a set of questionnaires to assess various parameters:
- Irritable Bowel Syndrome Quality of Life (IBS-QOL);
- Quality of Life - Short Form-36 (SF-36);
- Symptoms of Anxiety and/or Depression - Hospital Anxiety and Depression Scale (HADS);
- State and Trait Anxiety Levels - State-Trait Anxiety Inventory (STAI);
- Visceral Sensitivity - Visceral Sensitivity Index (VSI);
Stage 2: Participants will be randomized into one of two groups: a chatbot group (intervention) and a standard care group (control). Prior to enrollment, both groups will receive a consultation with a gastroenterologist providing information on lifestyle, diet, and treatment. The intervention group will receive the access to a chatbot.
At the fourth and eighth week of follow-up participants in both groups will be asked to re-complete the set of questionnaires (IBS-QOL, SF-36, HADS, STAI, VSI). No routine gastroenterologist consultations will be scheduled during the follow-up period.
Stage 3: Results from the questionnaires will be analyzed and used to formulate conclusions.
- Conditions
- Irritable Bowel Syndrome, Irritable Bowel Syndrome - Constipation, Irritable Bowel Syndrome - Diarrhoea, Irritable Bowel Syndrome - Mixed
- Being tested
- Chatbot supporting system
- Keywords
- IBS, Irritable Bowel Syndrome, chatbot, eHealth
- Medical subject headings
- Irritable Bowel Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chatbot supporting systemDevice
The intervention tool is the automated chatbot supporting system, which contains:
- educational information (therapeutic education and psychoeducation); B) symptom monitoring (stool quality and frequency, assessment of mood, sleep quality, physical activity, and dietary adherence on a scale of 0 to 10); C) behavioral distraction techniques, and body tension reduction techniques.
| Study group | Role | What they receive |
|---|---|---|
| Chatbot group | Experimental | The group will receive access to the automated chatbot supporting system. Each patient will receive a unique access code (token) to register for the chatbot. Only patients with tokens present in the authorized database will be able to register, thus ensuring that the chatbot is exclusively used by study participants. Receives: Device: Chatbot supporting system |
| Standart care group | No intervention | The group will receive standart care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change the Health-related quality of life in IBS
Change the quality of life in IBS according to Irritable Bowel Syndrome Quality of Life (IBS-QOL) questionnaire. The IBS-QOL is a self-report quality-of-life measure specific to Irritable Bowel Syndrome (IBS) that can be used to assess the impact of IBS and its treatment. Max score is 100, min score is 0.
Higher score means better outcome
Measured: 8 weeks
Change the Health-related quality of life in IBS
Change the quality of life in IBS according to Short Form-36 (SF-36) questionnaire. The questionnaire consists of 8 sections:
- Vitality;
- Physical functioning;
- Bodily pain;
- General health perceptions;
- Physical role functioning;
- Emotional role functioning;
- Social role functioning;
- Mental health; For each section scores range from 0 to 100. Lower scores mean more disability, higher scores mean less disability.
Measured: 8 weeks
Secondary outcomes (3)
Change psychological well-being of patients with IBS measured by HADS
Change psychological well-being of patients with IBS according to Hospital Anxiety and Depression Scale (HADS). Each item is scored on a response-scale with four alternatives ranging between 0 and 3. Score 8-10 for doubtful cases and ≥11 for definite cases of depression and anxiety.
Measured: 8 weeks
Change psychological well-being of patients with IBD measured by VSI
Change psychological well-being of patients with IBD according to Visceral Sensitivity Index (VSI). Min value is 0, max value is 75. 0-10 - no GI-specific anxiety; 11-30 - moderate GI-specific anxiety; 31 - 75 - severe GI-specific anxiety; Lower score means better outcome.
Measured: 8 weeks
Change psychological well-being of patients with IBS measured by STAI
Change psychological well-being of patients with IBS measured by State-Trait Anxiety Inventory (STAI) questionnaire. The STAI has 20 items to assess trait anxiety and 20 to assess state anxiety. The score range for each subscale is 20-80, the higher score indicating anxiety.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2025
- Study startMar 2025 (estimated)
- Primary completionMay 2025 (estimated)
- Study completionAug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Irritable Bowel SyndromeStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 54 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Research and Practical Clinical Center for Diagnostics and Telemedicine Technologies of the Moscow Health Care Department
- Sponsor type
- University, hospital or other
- Collaborators
- I.M. Sechenov First Moscow State Medical University
- Responsible party
- Principal investigator, Anton V. Vladzymyrskyy, Research and Practical Clinical Center for Diagnostics and Telemedicine Technologies of the Moscow Health Care Department
- Investigators
- Anton V. Vladzymyrskyy, PhD, Study director, Research and Practical Clinical Center for Diagnostics and Telemedicine Technologies of the Moscow Health Care Department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06837064
- Sponsor's protocol ID
- 2025-1
- Acronym
- IrBiS
- Status last verified
- Feb 2025
- First submitted
- 10 Feb 2025
- Last updated
- 20 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Efficacy of Chatbot-based Automated Support System for Patients with Irritable Bowel Syndrome (IBS)
- ClinicalTrials.gov ID
- NCT06837064
- Acronym / sponsor ID
- IrBiS / 2025-1
- Conditions
- Irritable Bowel Syndrome, Irritable Bowel Syndrome - Constipation, Irritable Bowel Syndrome - Diarrhoea, Irritable Bowel Syndrome - Mixed
- Keywords
- IBS, Irritable Bowel Syndrome, chatbot, eHealth
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 54 participants (estimated)
- Lead sponsor
- Research and Practical Clinical Center for Diagnostics and Telemedicine Technologies of the Moscow Health Care DepartmentUniversity, hospital or other
- Collaborators
- I.M. Sechenov First Moscow State Medical University
- Study start
- Mar 2025 (estimated)
- Primary completion
- May 2025 (estimated)
- Study completion
- Aug 2025 (estimated)
- First posted
- 20 Feb 2025 (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.
The goal of this clinical trial is to evaluate the efficacy of an automated chatbot system in improving quality of life, reducing depression and anxiety, and decreasing visceral sensitivity in patients with Irritable Bowel Syndrome. The main research question is:
Is an automated chatbot as effective for patients with IBS as standard care? Participants will be asked to complete online surveys to assess quality of life, symptoms of depression and anxiety, and visceral sensitivity before and after the intervention.
Detailed description
The study consists of three stages:
Stage 1: Patients with Irritable Bowel Syndrome (IBS) who meet the eligibility criteria will be invited to participate in the study. After providing written informed consent, all participants will be asked to complete a set of questionnaires to assess various parameters:
- Irritable Bowel Syndrome Quality of Life (IBS-QOL);
- Quality of Life - Short Form-36 (SF-36);
- Symptoms of Anxiety and/or Depression - Hospital Anxiety and Depression Scale (HADS);
- State and Trait Anxiety Levels - State-Trait Anxiety Inventory (STAI);
- Visceral Sensitivity - Visceral Sensitivity Index (VSI);
Stage 2: Participants will be randomized into one of two groups: a chatbot group (intervention) and a standard care group (control). Prior to enrollment, both groups will receive a consultation with a gastroenterologist providing information on lifestyle, diet, and treatment. The intervention group will receive the access to a chatbot.
At the fourth and eighth week of follow-up participants in both groups will be asked to re-complete the set of questionnaires (IBS-QOL, SF-36, HADS, STAI, VSI). No routine gastroenterologist consultations will be scheduled during the follow-up period.
Stage 3: Results from the questionnaires will be analyzed and used to formulate conclusions.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Chatbot group | Experimental | Device: Chatbot supporting systemThe group will receive access to the automated chatbot supporting system. Each patient will receive a unique access code (token) to register for the chatbot. Only patients with tokens present in the authorized database will be able to register, thus ensuring that the chatbot is exclusively used by study participants. |
| Standart care group | No intervention | –The group will receive standart care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adults ≥18 years;
- Diagnosed with IBS;
- Signed informed consent.
Key exclusion criteria (7 listed)
- Age under 18 years;
- Pregnant individuals;
- Patients with cognitive or sensory impairments that hinder understanding of questions in surveys, scales, or instruments used in the study;
- Patients unable to use a chatbot;
- Patients currently participating in any other clinical trial or experimental study;
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 |
|---|---|---|
| Chatbot supporting systemThe intervention tool is the automated chatbot supporting system, which contains: A) educational information (therapeutic education and psychoeducation); B) symptom monitoring (stool quality and frequency, assessment of mood, sleep quality, physical activity, and dietary adherence on a scale of 0 to 10); C) behavioral distraction techniques, and body tension reduction techniques. | Device | Chatbot group |
Primary outcome
Change the Health-related quality of life in IBS
Time frame: 8 weeks
Change the quality of life in IBS according to Irritable Bowel Syndrome Quality of Life (IBS-QOL) questionnaire. The IBS-QOL is a self-report quality-of-life measure specific to Irritable Bowel Syndrome (IBS) that can be used to assess the impact of IBS and its treatment. Max score is 100, min score is 0. Higher score means better outcome
Change the Health-related quality of life in IBS
Time frame: 8 weeks
Change the quality of life in IBS according to Short Form-36 (SF-36) questionnaire. The questionnaire consists of 8 sections: * Vitality; * Physical functioning; * Bodily pain; * General health perceptions; * Physical role functioning; * Emotional role functioning; * Social role functioning; * Mental health; For each section scores range from 0 to 100. Lower scores mean more disability, higher scores mean less disability.
3 secondary outcomes
Change psychological well-being of patients with IBS measured by HADS
Time frame: 8 weeks
Change psychological well-being of patients with IBD measured by VSI
Time frame: 8 weeks
Change psychological well-being of patients with IBS measured by STAI
Time frame: 8 weeks
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 Feb 2025.
- Individual participant dataSharing planned: Undecided
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A Study of Brenipatide (LY3537031) in Participants With Irritable Bowel Syndrome-Constipation (IBS-C)
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A Study of Brenipatide (LY3537031) in Participants With Irritable Bowel Syndrome-Diarrhea (IBS-D)
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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.
Anton V. Vladzymyrskyy, PhD study director
Research and Practical Clinical Center for Diagnostics and Telemedicine Technologies of the Moscow Health Care Department
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Chatbot supporting system in people with Irritable Bowel Syndrome and Irritable Bowel Syndrome - Constipation, run by Research and Practical Clinical Center for Diagnostics and Telemedicine Technologies of the Moscow Health Care Department 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 7 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: enrolling by invitation, as of the sponsor's last update on 20 Feb 2025. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change the Health-related quality of life in IBS (time frame: 8 weeks). The study lists 2 primary outcomes in all. 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 Feb 2025.