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Multicenter, real-world clinical study of Calcium polycarbophil tablets in the treatment of IBS-C and IBS-M

Multicenter, real-world clinical study of Calcium polycarbophil tablets in the treatment of IBS-C and IBS-M

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2400087674
Enrollment
Unknown
Registered
2024-08-01
Start date
2024-08-15
Completion date
Unknown
Last updated
2024-08-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

IBS-C and IBS-M

Interventions

Control group: Probiotics treatment:None
Experimental group: Calcium polycarbofylcalcium tablets combined with probiotics:None

Sponsors

Zhejiang Provincial Hospital of Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: (1) Newly diagnosed patients who meet the diagnostic criteria of IBS-C/IBS-M in Rome IV; (2) Age = 18 years old, regardless of sex; (3) No organic diseases were found in at least one examination of colonoscopy or colon barium radiography within 5 years; (4) The previous week's abdominal pain score NRS-11 = 3 (0: no pain; 1-3 points: mild pain; 4-6 points: moderate pain; 7-10 points: severe pain); (5) The average number of complete spontaneous defecation in the previous week (CSBM) is less than 3, and the number of spontaneous defecation (SBM) is less than 5 (IBS-M is not required); (6) Voluntarily participate in this study and sign the informed consent form.

Exclusion criteria

Exclusion criteria: (1) Patients with acute abdominal diseases (appendicitis, intestinal bleeding, ulcerative colitis); (2) Patients who may have intestinal obstruction after operation; (3) Patients with hypercalcemia; (4) kidney calculi patients; (5) Patients with renal insufficiency (except patients with mild renal insufficiency and dialysis); (6) allergic to any ingredient in this product; (7) There are warning signs; (8) Pregnant or lactating women; (9) Patients who use proton pump blockers (omeprazole, lansoprazole, etc.), H2 receptor antagonists (famotidine, ranitidine, etc.), antacids (aluminum hydroxide, magnesium hydroxide, etc.) and other drugs that can lead to an increase in gastric pH; (10) Patients considered unsuitable by other researchers.

Design outcomes

Primary

MeasureTime frame
Numerical rating scale, NRS-11;Numerical rating scale, NRS-11;Complete spontaneous bowel movements, CSBMs;—

Secondary

MeasureTime frame
Irritable Bowel Syndrome Symptom Severity Score;Irritable Bowel Syndrome-Quality of Life;Bristol Stool Scale;—

Countries

China

Contacts

Public ContactLv Bin

Zhejiang Provincial Hospital of Chinese Medicine

lvbin@medmail.com.cn+86 139 0651 5409

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026