irritable bowel syndrome
Conditions
Interventions
Provide an application that offers psychotherapy to the test device group or sham device group.
Sponsors
Hanadate Tadaatsu
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Individual diagnosed with IBS based on the Rome IV criteria. 2. Those who, despite initiating the first-stage treatment (diet therapy/behavioral modification, gastrointestinal motility modifiers, probiotics, bulking polymer, 5-HT3 antagonists, intestinal secretagog ues, etc.) or the second-stage treatment (administration of psychotropic drugs, etc.) as outlined in the "Evidence-based clinical practice guidelines for irritable bowel syndrome 2020" (The Jap anese Society of Gastroenterology), have not seensufficient improvement in symptoms (falling between 3-7 on the Global Improvement Scale) after 8 weeks or more. 3, Those who possess a smartphone capable of using the application. 4, Age: Those aged between 16 and 75 at the time of consent acquisition. 5. Gender: Not specified. 6. Those who, after receiving a thorough explanation about the study, have given their informed writ ten consent of their own free will. 7. Individuals able to attend outpatient visits according to the research schedule.
Exclusion criteria
Exclusion criteria: 1. Pregnant women or women who may be pregnant 2. Patients with other conditions that should be given priority over the treatment of irritable bowel syndrome, such as malignant tumors or severe mental illnesses 3. Patients who, at the time of consent acquisition, have participated in another clinical trial or clini cal research within the past 3 months. 4. Other patients whom the principal investigator or co-investigator deems unsuitable for participation in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in the IBSSI-J score from baseline at 12 weeks | — |
Contacts
Public ContactTadaatsu Hanadate
MICIN Inc.
Outcome results
None listed