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

NCT07543354 | Not Yet Recruiting

• 1 other identifier: 2025-05-001CC
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

IBS - Irritable Bowel Syndrome

Keywords

Low FODMAP; microbiota-gut-brain axis; IBS

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Patient-Reported Outcomes Measurement Information System (PROMIS) Gastrointestinal Symptom Scales

  Baseline (Week 0) and post-intervention (Week 14-6), reintroduction Phase (12 weeks), Personalization & Followup (16 weeks)

• Gastrointestinal symptom evaluation

  Baseline (Week 0) and post-intervention (Week 14-6), reintroduction Phase (12 weeks), Personalization & Followup (16 weeks)

• IBS- quality of life (IBS-QOL)

  Baseline (Week 0) and post-intervention (Week 14-6), reintroduction Phase (12 weeks), Personalization & Followup (16 weeks)

• Hospital Anxiety and Depression Scale (HADS)

  Baseline (Week 0) and post-intervention (Week 14-6), reintroduction Phase (12 weeks), Personalization & Followup (16 weeks)

Study Arms (2)

AI-assisted LFDapp group

EXPERIMENTAL

Participants receive low-FODMAP diet education supported by a dedicated AI-assisted mobile application.

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.

Behavioral: LFD booklet group

Interventions

AI-assisted Mobile Application for Low-FODMAP Diet BEHAVIORAL

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.

AI-assisted LFDapp group

LFD booklet group BEHAVIORAL

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.

LFD booklet group

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Taipei Veterans General Hospital, Taiwan: lead

Study Sites (1)

Taipei Veterans General Hospital

Taipei, 112, Taiwan

Location

MeSH Terms

Conditions

Irritable Bowel Syndrome

Interventions

FODMAP Diet

Condition Hierarchy (Ancestors)

Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Elimination Diets; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Randomly assigned in a 1:1 ratio to either the LFD app or LFD booklet group using a computer-generated random number table. The randomization sequence was sealed in opaque sealed envelopes, opened just before meeting the patients
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 14, 2026
• First Posted: April 21, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): June 1, 2028
• Study Completion (Estimated): June 1, 2029
• Last Updated: April 21, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)