IBS - Irritable Bowel SyndromeNCT07543354
Personalized Therapy of Long-term Low FODMAP in IBS Treatment: Role of Mobile Application and "Microbiota-gut-brain" Axis
A study testing AI-assisted Mobile Application for Low-FODMAP Diet and LFD booklet group in people with IBS - Irritable Bowel Syndrome, run by Taipei Veterans General Hospital, Taiwan at 1 site in Taiwan.
Trial 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). Read more about this study
- Who is it for?
- Ages 20 to 65 years
- Conditions the study is for
- IBS - Irritable Bowel Syndrome
- What is being tested?
- AI-assisted Mobile Application for Low-FODMAP Diet and LFD booklet group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteTaiwan
- Study dates
- Apr 2026to Jun 2029
- 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 20 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan1 site
Taipei Veterans General Hospital
Taipei, 112
Research Assistant, +886-2-28712121, pswu2@vgte.gov.tw
About this study
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.
Read more
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.
- Conditions
- IBS - Irritable Bowel Syndrome
- Being tested
- AI-assisted Mobile Application for Low-FODMAP Diet, LFD booklet group
- Keywords
- Low FODMAP, microbiota-gut-brain axis, IBS
- 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.
AI-assisted Mobile Application for Low-FODMAP DietBehavioural
Participants in this group will receive a specialized AI-assisted mobile application (LFDapp) to manage their diet. The app provides real-time guidance, meal suggestions, and tracking tools to help clinicians and dietitians establish a personalized low-FODMAP dietary treatment plan. Participants will follow the diet for an initial 4-6 weeks, followed by a reintroduction and personalization phase.
LFD booklet groupBehavioural
Participants in this group will receive dietary education using printed LFD booklets. The booklet includes dietary guidelines, food lists (high vs. low FODMAP), and sample meal plans provided by a dietitian. Participants will follow the same intervention timeline (initial 4-6 weeks, reintroduction, and personalization) as the app group but without mobile app support.
| Study group | Role | What they receive |
|---|---|---|
| AI-assisted LFDapp group | Experimental | Participants receive low-FODMAP diet education supported by a dedicated AI-assisted mobile application. Receives: Behavioral: AI-assisted Mobile Application for Low-FODMAP Diet |
| LFD booklet group | Active comparator | Participants receive low-FODMAP diet education using traditional printed educational booklets. Receives: Behavioral: LFD booklet group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in Irritable Bowel Syndrome Symptom Severity Scale (IBS-SSS) score.
The IBS-SSS is a validated scale used to assess the severity of IBS symptoms. It consists of five items: abdominal pain severity, abdominal pain frequency, abdominal distension/bloating, dissatisfaction with bowel habits, and interference with life. Each item is scored from 0 to 100, for a total possible score of 500. Higher scores indicate more severe symptoms. (A decrease in score represents clinical improvement).
Measured: Baseline (Week 0) and post-intervention (Week 4-6), reintroduction Phase (12 weeks), Personalization & Follow-up (16 weeks):
Secondary outcomes (4)
Patient-Reported Outcomes Measurement Information System (PROMIS) Gastrointestinal Symptom Scales
A standardized 5-item, patient-reported tool used to measure the frequency and severity of abdominal pain or discomfort over a 7-day period. The total score ranges from 5 to 25, where higher scores indicate greater symptom severity (a worse outcome).
Measured: Baseline (Week 0) and post-intervention (Week 14-6), reintroduction Phase (12 weeks), Personalization & Followup (16 weeks)
Gastrointestinal symptom evaluation
To evaluate the current gastrointestinal symptom status, the gastrointestinal symptom rating scale (GSRS) will be used. GSRS is an interview-based 7-likert rating scale consisting of 15 items for assessment of gastrointestinal symptoms for irritable bowel syndrome and peptic ulcer disease.The total score ranges from 15 to 105, with higher scores representing more severe symptoms (a worse outcome).
Measured: Baseline (Week 0) and post-intervention (Week 14-6), reintroduction Phase (12 weeks), Personalization & Followup (16 weeks)
IBS- quality of life (IBS-QOL)
IBS-QOL is a validated condition-specific QOL measure for IBS.29 It contains of 34 items focusing on different conditions including dysphoria, interference with activity, body image, health worry, food avoidance, social reaction, sexual and relationship. IBS-QOL has been used to evaluate the overall health related QOL influenced by IBS.Each item is scored on a 5-point scale, and the total raw score is transformed to a 0-100 scale. Higher scores indicate better health-related quality of life (a better outcome).
Measured: Baseline (Week 0) and post-intervention (Week 14-6), reintroduction Phase (12 weeks), Personalization & Followup (16 weeks)
Hospital Anxiety and Depression Scale (HADS)
HADS is a simple developed scale used by doctors to evaluate anxiety and depression condition of a patient. It is often used to evaluate patients with different diseases, such as psychiatric, cancer, chronic pain or handicapped to evaluate about their emotional condition. Each subscale score ranges from 0 to 21, where higher scores indicate greater levels of anxiety or depression (a worse outcome).It had been translated in Chinese version and used in many previous studies.
Measured: Baseline (Week 0) and post-intervention (Week 14-6), reintroduction Phase (12 weeks), Personalization & Followup (16 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2026
- Study startApr 2026 (estimated)
- Primary completionJun 2028 (estimated)
- Study completionJun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for IBS - Irritable Bowel SyndromeStudies of the same condition, open and under way.
- More trials run by Taipei Veterans General Hospital, TaiwanThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Taipei Veterans General Hospital, Taiwan
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07543354
- Sponsor's protocol ID
- 2025-05-001CC
- Status last verified
- May 2026
- First submitted
- 14 Apr 2026
- Last updated
- 15 May 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 15 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Personalized Therapy of Long-term Low FODMAP in IBS Treatment: Role of Mobile Application and "Microbiota-gut-brain" Axis
- ClinicalTrials.gov ID
- NCT07543354
- Acronym / sponsor ID
- 2025-05-001CC
- Conditions
- IBS - Irritable Bowel Syndrome
- Keywords
- Low FODMAP, microbiota-gut-brain axis, IBS
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Taipei Veterans General Hospital, TaiwanOther government
- Study start
- Apr 2026 (estimated)
- Primary completion
- Jun 2028 (estimated)
- Study completion
- Jun 2029 (estimated)
- First posted
- 21 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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AI-assisted LFDapp group | Experimental | Behavioral: AI-assisted Mobile Application for Low-FODMAP DietParticipants receive low-FODMAP diet education supported by a dedicated AI-assisted mobile application. |
| LFD booklet group | Active comparator | Behavioral: LFD booklet groupParticipants receive low-FODMAP diet education using traditional printed educational booklets. |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (18 listed)
- 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.
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 |
|---|---|---|
| AI-assisted Mobile Application for Low-FODMAP DietParticipants in this group will receive a specialized AI-assisted mobile application (LFDapp) to manage their diet. The app provides real-time guidance, meal suggestions, and tracking tools to help clinicians and dietitians establish a personalized low-FODMAP dietary treatment plan. Participants will follow the diet for an initial 4-6 weeks, followed by a reintroduction and personalization phase. | Behavioural | AI-assisted LFDapp group |
| LFD booklet groupParticipants in this group will receive dietary education using printed LFD booklets. The booklet includes dietary guidelines, food lists (high vs. low FODMAP), and sample meal plans provided by a dietitian. Participants will follow the same intervention timeline (initial 4-6 weeks, reintroduction, and personalization) as the app group but without mobile app support. | Behavioural | LFD booklet group |
Primary outcome
Change from baseline in Irritable Bowel Syndrome Symptom Severity Scale (IBS-SSS) score.
Time frame: Baseline (Week 0) and post-intervention (Week 4-6), reintroduction Phase (12 weeks), Personalization & Follow-up (16 weeks):
The IBS-SSS is a validated scale used to assess the severity of IBS symptoms. It consists of five items: abdominal pain severity, abdominal pain frequency, abdominal distension/bloating, dissatisfaction with bowel habits, and interference with life. Each item is scored from 0 to 100, for a total possible score of 500. Higher scores indicate more severe symptoms. (A decrease in score represents clinical improvement).
4 secondary outcomes
Patient-Reported Outcomes Measurement Information System (PROMIS) Gastrointestinal Symptom Scales
Time frame: Baseline (Week 0) and post-intervention (Week 14-6), reintroduction Phase (12 weeks), Personalization & Followup (16 weeks)
Gastrointestinal symptom evaluation
Time frame: Baseline (Week 0) and post-intervention (Week 14-6), reintroduction Phase (12 weeks), Personalization & Followup (16 weeks)
IBS- quality of life (IBS-QOL)
Time frame: Baseline (Week 0) and post-intervention (Week 14-6), reintroduction Phase (12 weeks), Personalization & Followup (16 weeks)
Hospital Anxiety and Depression Scale (HADS)
Time frame: Baseline (Week 0) and post-intervention (Week 14-6), reintroduction Phase (12 weeks), Personalization & Followup (16 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 15 May 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?
A study testing AI-assisted Mobile Application for Low-FODMAP Diet and LFD booklet group in people with IBS - Irritable Bowel Syndrome, run by Taipei Veterans General Hospital, Taiwan at 1 site in Taiwan.
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 18 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 15 May 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 Taiwan. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in Irritable Bowel Syndrome Symptom Severity Scale (IBS-SSS) score. (time frame: Baseline (Week 0) and post-intervention (Week 4-6), reintroduction Phase (12 weeks), Personalization & Follow-up (16 weeks):). 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 15 May 2026.