Irritable Bowel Syndrome
Conditions
Interventions
Comprehensive eHealth System Group (Enhanced Intervention Group) Duration and Frequency: Total intervention period: 3 months (12 weeks) eLearning (diet, exercise, rest): 1. 5-chapter structure
Sponsors
Saitama Prefectural University
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. Gender: Female 2. Age: 20-65 years old 3. Having symptoms of Irritable Bowel Syndrome (IBS) based on Rome IV diagnostic criteria 4. Japanese ethnicity 5. Ability to understand the purpose and procedures of the research and willingness to participate voluntarily 6. Ability to provide written informed consent 7. Having access to the internet and an environment capable of utilizing the e-learning system (or ability to use loaned devices during the research period) 8. Ability to participate in required assessments (baseline, 6 weeks, and 3 months) during the research period (3 months) 9. Ability to provide fecal samples
Exclusion criteria
Exclusion criteria: 1. Diagnosed with psychiatric disorders (depression, anxiety disorders, schizophrenia, eating disorders, etc.) 2. Diagnosed with gastrointestinal diseases other than IBS (inflammatory bowel disease, celiac disease, gastrointestinal malignancies, etc.) 3. Use of antibiotics within the past 3 months 4. Using electronic medical devices such as cardiac pacemakers (due to potential interference with EEG measurement devices) 5. Individuals deemed unsuitable for research participation by the researchers 6. Pregnant or breastfeeding women 7. Individuals with severe constipation or diarrhea requiring medical intervention 8. Currently receiving specific drug treatment for IBS with planned medication changes during the research period 9. Previous experience with structured psychological interventions for IBS (such as cognitive behavioral therapy) 10. Participation in other clinical trials
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in Irritable Bowel Syndrome Severity Index (IBS-SI) score Measurement method: Self-reported IBS-SI questionnaire Measurement timing: Baseline (pre-intervention), 6 weeks post-intervention, and 3 months post-intervention Assessment content: Comprehensive IBS symptom severity including abdominal pain intensity, frequency, abdominal bloating, satisfaction with bowel habits, and interference with daily life Primary evaluation point: Change in IBS-SI score from baseline to 3 months post-intervention | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Changes in gut microbiota diversity and composition Measurement method: Metagenomic analysis of fecal samples Measurement timing: Baseline, 6 weeks post-intervention, and 3 months post-intervention 2. Changes in brain wave patterns Measurement method: Electroencephalogram (EEG) measurements Measurement timing: Baseline, 6 weeks post-intervention, and 3 months post-intervention Assessment content: Resting-state brain activity and brain activity related to interoceptive processing 3. Improvement in IBS-specific quality of life (IBS-QOL) score Measurement method: IBS-QOL questionnaire Measurement timing: Baseline, 6 weeks post-intervention, and 3 months post-intervention 4. Interoceptive awareness Measurement method: Multidimensional Assessment of Interoceptive Awareness (MAIA) questionnaire Measurement timing: Baseline, 6 weeks post-intervention, and 3 months post-intervention 5. Changes in eating behavior patterns Measurement method: Eating Behavior Scale (EBS) and FODMAP intake assessment Measurement timing: Baseline, 6 weeks post-intervention, and 3 months post-intervention 6. Changes in psychological measures Measurement method: Visceral Sensitivity Index (VSI) and K6 questionnaire Measurement timing: Baseline, 6 weeks post-intervention, and 3 months post-intervention 7. Autonomic nervous system function Measurement method: Autonomic assessment via finger photoplethysmography Measurement timing: Baseline, 6 weeks post-intervention, and 3 months post-intervention | — |
Countries
Japan
Contacts
Public ContactKaneko Mutsumi
Saitama Prefectural University Secretariat, Research and Community Relations
Outcome results
None listed