Personalized Therapy of Long-term Low FODMAP in IBS Treatment: Role of Mobile Application and "Microbiota-gut-brain" Axis

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 Overview

• Status: Not yet recruiting
• Conditions: IBS - Irritable Bowel Syndrome
• Intervention / Treatment: Behavioral: AI-assisted Mobile Application for Low-FODMAP Diet; Behavioral: LFD booklet group

• Study Type: Interventional
• Enrollment (Estimated): 200
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • Taipei, Taiwan, 112
    • Taipei Veterans General Hospital
    • Contact: Research Assistant; Phone Number: +886-2-28712121; Email: pswu2@vgte.gov.tw

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: AI-assisted LFDapp group; Participants receive low-FODMAP diet education supported by a dedicated AI-assisted mobile application.	Behavioral: AI-assisted Mobile Application for Low-FODMAP Diet; 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.
Active Comparator: LFD booklet group; Participants receive low-FODMAP diet education using traditional printed educational booklets.	Behavioral: LFD booklet group; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	Baseline (Week 0) and post-intervention (Week 4-6), reintroduction Phase (12 weeks), Personalization & Follow-up (16 weeks):

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	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).	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).	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.	Baseline (Week 0) and post-intervention (Week 14-6), reintroduction Phase (12 weeks), Personalization & Followup (16 weeks)

Collaborators and Investigators

• Sponsor: Taipei Veterans General Hospital, Taiwan

Study record dates

Study Major Dates

• Study Start (Estimated): April 1, 2026
• Primary Completion (Estimated): June 1, 2028
• Study Completion (Estimated): June 1, 2029

Study Registration Dates

• First Submitted: April 14, 2026
• First Submitted That Met QC Criteria: April 14, 2026
• First Posted (Actual): April 21, 2026

Study Record Updates

• Last Update Posted (Actual): May 15, 2026
• Last Update Submitted That Met QC Criteria: May 12, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: IBS; microbiota-gut-brain axis; Low FODMAP
• Additional Relevant MeSH Terms: Intestinal Diseases; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Colonic Diseases, Functional; Irritable Bowel Syndrome; Diet, Food, and Nutrition; Physiological Phenomena; Nutritional Physiological Phenomena; Diet; Elimination Diets; FODMAP Diet
• Other Study ID Numbers: 2025-05-001CC

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No