IBSNCT07809646
Cl-Pharm-IBS-ML-2026
An observational study of IBS, run by Tanta University.
Trial summary
The purpose of this study is to identify distinct subgroups (phenotypes) of Irritable Bowel Syndrome (IBS) patients. While traditional IBS classification relies mainly on bowel habits, this research uses a multidimensional questionnaire to capture clinical symptoms, psychological factors, diet triggers, sleep quality… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- IBS
- What is being tested?
- Questionnaire and Physical Exam
- How many people
- 500 participants
- Where
- No sites listed yet
- Study dates
- 20 Sep 2026to 1 Jan 2027
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: A convenience sample of adult patients with a physician-confirmed diagnosis of Irritable Bowel Syndrome (IBS) recruited from online health communities, clinical networks, and social media platforms. The population includes individuals across various demographic backgrounds, IBS subtypes, and symptom severity levels, who are capable of completing a digital questionnaire regarding their clinical and lifestyle characteristics.
Who may be able to join
- Participants aged 18 years or older.
- Formal physician-confirmed diagnosis of Irritable Bowel Syndrome (IBS).
- Ability to access and complete the digital multidimensional questionnaire.
- Willingness to provide digital informed consent.
Who cannot join
- Presence of organic gastrointestinal diseases (e.g., Inflammatory Bowel Disease, celiac disease, or colorectal cancer).
- Presence of alarm/red flag symptoms (e.g., nocturnal symptoms waking the patient).
- Incomplete or inconsistent questionnaire responses.
About this study
Official title: Machine Learning-Based Phenotyping of IBS Patients Using Multidimensional Patient-Reported Outcomes
The purpose of this study is to identify distinct subgroups (phenotypes) of Irritable Bowel Syndrome (IBS) patients. While traditional IBS classification relies mainly on bowel habits, this research uses a multidimensional questionnaire to capture clinical symptoms, psychological factors, diet triggers, sleep quality, and digital behaviors. By applying advanced machine learning algorithms to these patient-reported outcomes, the study aims to uncover hidden patterns that can help customize future treatments and improve patient care.
- Conditions
- IBS
- Being tested
- Questionnaire and Physical Exam
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Questionnaire and Physical ExamOther
ONLINE QUESTIONNAIRE
What is being measured
The primary outcome is the main question the study is designed to answer.
Distinct patient subgroups (phenotypes) identified through unsupervised machine learning clustering algorithms.
Measured: At the time of questionnaire completion (Baseline)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2026
- Study start20 Sep 2026 (estimated)
- Primary completion1 Jan 2027 (estimated)
- Study completion1 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for IBSStudies 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Khadija Ahmed Mhrose Glal, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07809646
- Sponsor's protocol ID
- REC-TU-2026-85
- Status last verified
- Sep 2026
- First submitted
- 3 Sep 2026
- Last updated
- 11 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Machine Learning-Based Phenotyping of IBS Patients Using Multidimensional Patient-Reported Outcomes
- ClinicalTrials.gov ID
- NCT07809646
- Acronym / sponsor ID
- REC-TU-2026-85
- Conditions
- IBS
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 20 Sep 2026 (estimated)
- Primary completion
- 1 Jan 2027 (estimated)
- Study completion
- 1 Jan 2027 (estimated)
- First posted
- 9 Sep 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.
The purpose of this study is to identify distinct subgroups (phenotypes) of Irritable Bowel Syndrome (IBS) patients. While traditional IBS classification relies mainly on bowel habits, this research uses a multidimensional questionnaire to capture clinical symptoms, psychological factors, diet triggers, sleep quality, and digital behaviors. By applying advanced machine learning algorithms to these patient-reported outcomes, the study aims to uncover hidden patterns that can help customize future treatments and improve patient care.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- A convenience sample of adult patients with a physician-confirmed diagnosis of Irritable Bowel Syndrome (IBS) recruited from online health communities, clinical networks, and social media platforms. The population includes individuals across various demographic backgrounds, IBS subtypes, and symptom severity levels, who are capable of completing a digital questionnaire regarding their clinical and lifestyle characteristics.
Key inclusion criteria (4 listed)
- Participants aged 18 years or older.
- Formal physician-confirmed diagnosis of Irritable Bowel Syndrome (IBS).
- Ability to access and complete the digital multidimensional questionnaire.
- Willingness to provide digital informed consent.
Key exclusion criteria (3 listed)
- Presence of organic gastrointestinal diseases (e.g., Inflammatory Bowel Disease, celiac disease, or colorectal cancer).
- Presence of alarm/red flag symptoms (e.g., nocturnal symptoms waking the patient).
- Incomplete or inconsistent questionnaire responses.
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 Physical ExamONLINE QUESTIONNAIRE | Other | – |
Primary outcome
Distinct patient subgroups (phenotypes) identified through unsupervised machine learning clustering algorithms.
Time frame: At the time of questionnaire completion (Baseline)
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 11 Sep 2026.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of IBS, run by Tanta University.
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 4 inclusion and 3 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 11 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
Distinct patient subgroups (phenotypes) identified through unsupervised machine learning clustering algorithms. (time frame: At the time of questionnaire completion (Baseline)). 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 11 Sep 2026.