Irritable Bowel Syndrome (IBS)
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1.Patients who meet the diagnostic criteria for IBS-C according to Rome III; 2.Age >= 18 years, both males and females; 3.Within the past 5 years, at least one examination—either colonoscopy or barium enema—has been performed, showing no evidence of organic diseases; 4.Abdominal pain or discomfort, with an NRS-11 pain score >= 3 in the preceding week (0: no pain; 1–3: mild pain; 4–6: moderate pain; 7–10: severe pain); 5.In the preceding week, the average number of complete spontaneous bowel movements (CSBM, defined as bowel movements accompanied by a sense of complete evacuation without the use of laxatives or manual assistance) was < 3, and the number of spontaneous bowel movements (SBM, defined as bowel movements without the use of laxatives or manual assistance) was <= 5; 6.Voluntary participation in this study and provision of signed informed consent.
Exclusion criteria
Exclusion criteria: 1.Patients with acute abdominal conditions (e.g., appendicitis, intestinal hemorrhage, ulcerative colitis); 2.Patients who may develop intestinal obstruction after surgery; 3.Patients with hypercalcemia; 4.Patients with renal calculi (kidney stones); 5.Patients with renal dysfunction (excluding those with mild renal dysfunction and patients undergoing dialysis); 6.Patients with known hypersensitivity to any component of this product; 7.Patients presenting with alarm features; 8.Women who are pregnant or breastfeeding; 9.Patients using medications that increase gastric pH, such as proton pump inhibitors (e.g., omeprazole, lansoprazole), H2-receptor antagonists (e.g., famotidine, ranitidine), and antacids (e.g., aluminum hydroxide, magnesium hydroxide); 10.Other patients deemed ineligible for participation by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Abdominal discomfort or intensity of abdominal pain;Bowel movement frequency; | — |
Secondary
| Measure | Time frame |
|---|---|
| Incidence of diarrhea;NRS-11 scale score for abdominal pain and bloating;Weekly number of complete spontaneous bowel movements (CSBMs);Irritable Bowel Syndrome Severity Scoring System;Stool consistency; | — |
Countries
China
Contacts
Ningbo No.2 Hospital