Personalized Therapy of Long-term Low FODMAP in IBS Treatment: Role of Mobile Application and "Mi… (NCT07543354) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Personalized Therapy of Long-term Low FODMAP in IBS Treatment: Role of Mobile Application and "Microbiota-gut-brain" Axis
Taiwan200 participantsStarted 2026-04
Plain-language summary
The purpose of this study is to evaluate the effectiveness of a mobile application (app) in helping clinicians and dietitians provide personalized low-FODMAP diet (LFD) therapy for patients with Irritable Bowel Syndrome (IBS). The study also aims to explore the potential biological mechanisms behind the clinical outcomes of this dietary intervention.
Participants diagnosed with IBS will be recruited and screened through clinical questionnaires. Eligible participants will receive dietary education from a dietitian and be randomly assigned to one of two groups: the AI-assisted LFDapp group or the LFD booklet group.
The study consists of three main phases:
Initial Intervention (4-6 weeks): Participants will follow their assigned diet intervention and complete assessments regarding gastrointestinal symptoms, psychological traits (such as anxiety and depression), and quality of life.
Reintroduction Phase (12 weeks): Participants who respond well to the diet will enter a phase where specific foods are gradually reintroduced.
Personalization \& Follow-up (4 weeks): A personalized diet will be established, followed by a final evaluation of bowel function and mental well-being.
Researchers will use various standardized questionnaire to track changes in symptoms and overall well-being throughout the study period.
Who can participate
Age range
20 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Participants aged between 20 and 65 years.
* Diagnosed with Irritable Bowel Syndrome (IBS)
* Overall IBS symptoms remain unresolved or active at the time of enrollment.
Exclusion Criteria:
* Inability to understand the study procedures or provide written informed consent.
* Currently pregnant.
* History of Inflammatory Bowel Disease (IBD).
* Active infection within the past 90 days.
* History of thyroid disease.
* Major psychiatric disorders, including patients with significant anxiety or depression currently requiring treatment with anti-anxiety or anti-depressant medications.
* History of epilepsy.
* History of stroke, cerebral hemorrhage, or other central nervous system diseases.
* Significant renal, hepatic, or major cardiovascular diseases.
* Malignant diseases (cancer).
* Type 2 diabetes.
* Other chronic pain conditions.
* History of abdominal surgery (excluding cholecystectomy or appendectomy) or any history of brain surgery.
* Appendectomy or cholecystectomy performed within the past year.
* Currently participating in other clinical trials.
* Use of antibiotics or analgesics within 90 days prior to enrollment.
* Newly initiated use of probiotics or prebiotics within 90 days prior to enrollment.
* Current use of antipsychotic medications, antidiarrheal agents, probiotics, or analgesics.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change from baseline in Irritable Bowel Syndrome Symptom Severity Scale (IBS-SSS) score.