irritable bowel syndrome
Conditions
Interventions
In addition to existing treatments for IBS, a 10-session therapeutic program will be implemented based on the content displayed in
the EAM185 application, with each session intended to be conducted o
Sponsors
Chihiro Saito
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Patients aged 18 years or older at the time of providing written informed consent. 2.Patients diagnosed with IBS at least 4 weeks prior to the provisional registration date and who met the Rome IV diagnostic criteria on the provisional registration date. 3.Patients with an IBSSI-J score of 175 or higher on both the provisional and official registration dates. 4.Patients who, on the date of provisional registration, had received one or more types of drugs/therapies for the treatment of IBS for a total of 4 weeks or more, and for whom none of the treatments had demonstrated sufficient efficacy. 5.Patients who are able to communicate, read, and write in Japanese. 6.Patients who are able to attend outpatient visits. 7.Patients who can operate a device (smartphone) without difficulty. 8.Patienst who understand the purpose and content of the study, voluntarily provide written informed consent to participate, and are able to comply with the requirements of the study.
Exclusion criteria
Exclusion criteria: 1.Patients with current or past history of organic bowel disease. 2.Patients currently diagnosed with infectious enteritis. 3.Patients with a history of gastrointestinal resection. 4.Patients with prior experience of cognitive behavioral therapy. 5.Patients with severe anxiety disorders. 6.Patients with severe depression. 7.Patients with malignant tumors or those who have not completed five years since the end of treatment for malignant tumors. 8.Patients who are pregnant or may be pregnant. 9.Patients who have participated in another clinical trial and used an investigational drug or device within 16 weeks prior to providing written informed consent, or who plan to participate in another clinical trial during the study period. 10.Patients deemed inappropriate for participation in the study by the principal investigator or sub-investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in IBSSI-J score from baseline at the end of the treatment period | — |
Contacts
Public ContactSaito Chihiro
EA Pharma Co., Ltd
Outcome results
None listed