None listed
Conditions
Interventions
Drug : Patients were instructed to take the medication 30 minutes before meals. Adherence was monitored by counting the returned unused capsules at the end of weeks 2 and 4
participants with $<80\%$ adherence were excluded from the per-protocol analysis.
Sponsors
Uijeongbu Eulji Medical Center, Eulji University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients aged 18 to 75 years who met the Rome IV criteria for diarrhea-predominant IBS (IBS-D) or mixed IBS (IBS-M) were eligible. Inclusion required an average weekly abdominal pain score of ?4 on a 10-point Numeric Rating Scale (NRS) during a 1-week run-in period.
Exclusion criteria
Exclusion criteria: Key exclusion criteria included: (1) organic gastrointestinal diseases (e.g., inflammatory bowel disease, malignancy) confirmed by colonoscopy within the past 5 years; (2) history of major abdominal surgery; (3) severe systemic diseases (renal, hepatic, or cardiac failure); (4) pregnancy or lactation; and (5) use of other medications affecting GI motility or visceral sensitivity (e.g., opioids, antidepressants, other antispasmodics) within 2 weeks of the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| mean change in the NRS score for abdominal pain from baseline to week 4 | — |
Secondary
| Measure | Time frame |
|---|---|
| changes in psychological distress using the Beck Depression Inventory (BDI) and Beck Anxiety Inventory (BAI);improvement in health-related quality of life via the IBS-QoL questionnaire;changes in stool frequency and consistency (Bristol Stool Form Scale) | — |
Countries
Korea, Republic of
Contacts
Public ContactKIM OneJoong
Bundang CHA General Hospital
Outcome results
None listed