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NCT Number: NCT07543354

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.

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Key information

Conditions

IBS - Irritable Bowel Syndrome Colonic Diseases Colonic Diseases, Functional Digestive System Diseases Gastrointestinal Diseases Intestinal Diseases Irritable Bowel Syndrome

Age range

20 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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.

Primary outcomes

  1. 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).

Secondary outcomes

  1. 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)

    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).

  2. Gastrointestinal symptom evaluation

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

    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).

  3. 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)

    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).

  4. 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)

    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.

Sponsors and collaborators

Lead sponsor

Taipei Veterans General Hospital, Taiwan

Other Gov

Registry information

Important dates

Study start
2026
Primary completion
2028
Study completion
2029
First posted
Apr 21, 2026
Registry last updated
May 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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