Irritable Bowel Syndrome with Constipation (IBS-C)
Conditions
Interventions
Linaclotide Group:Administration of linaclotide
Linaclotide Plus Calcium Polycarbophil Group:Administration of linaclotide combined with calcium polycarbophil
Sponsors
Tongji Hospital, Tongji Medical College ,Huazhong University of Science and Technology
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Meet the Rome III diagnostic criteria for IBS-C; 2. Aged 18 to 65 years (inclusive), both genders; 3. Have undergone at least one of colonoscopy or colon air-contrast barium enema within the past 5 years with no findings of organic disease; 4. Have been informed of the trial and have signed the informed consent form.
Exclusion criteria
Exclusion criteria: 1. Those who meet the contraindications specified in the package insert of linaclotide or calcium polycarbophil; 2. Those with alarm signs (hematochezia, positive fecal occult blood test, anemia, weight loss, significant abdominal pain, abdominal mass, family history of colorectal polyps or colorectal tumors); 3. Those who have taken probiotics or antibiotics within the past 2 weeks; 4. Pregnant or lactating women; 5. Trial participants who cannot discontinue medications that may increase intragastric pH, including proton pump inhibitors (omeprazole, lansoprazole, etc.), H2 receptor antagonists (famotidine, ranitidine, etc.), and antacids (aluminum hydroxide, magnesium hydroxide, etc.); 6. Those using other Western or Chinese herbal medicines for constipation relief; 7. Those with insufficient study compliance who are unable to cooperate with follow-up or data recording; 8. Those with severe systemic or major organ diseases, or a history of specific drug allergies.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The proportion of participants in both groups who, at Week 4 of treatment, have an increase of 1 or more complete spontaneous bowel movements (CSBMs) over the 7?day period compared to baseline, and wh;Differences in intestinal barrier function markers (D-lactate, diamine oxidase, bacterial endotoxin) between the two groups at Week 4; | — |
Secondary
| Measure | Time frame |
|---|---|
| Differences in gut microbiota composition between the two groups at Week 4;Change from baseline in blood glucose and lipid profile (TC, TG, LDL-C, HDL-C) at Week 4;Change from baseline in IBS-SSS score and IBS-QOL score at Week 2 and Week 4;Change from baseline in Hospital Anxiety and Depression Scale (HADS) score at Week 2 and Week 4;Change from baseline in abdominal pain score and bloating score at Week 2 and Week 4;Proportion of patients with =30% reduction from baseline in weekly average of the worst abdominal pain score (NRS-11) over the past 24 hours at Week 2 and Week 4;Safety outcomes: incidence of adverse events (AEs), serious adverse events (SAEs), and specifically diarrhea;Change from baseline in Bristol Stool Form Scale score at Week 2 and Week 4; | — |
Countries
China
Contacts
Public ContactYu Qin
Tongji Hospital, Tongji Medical College ,Huazhong University of Science and Technology
Outcome results
None listed