Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 1:20 AM
Ignite Modification Date:
2025-12-25 @ 1:20 AM
NCT ID:
NCT05311293
Eligibility Criteria:
Inclusion Criteria:
1. Meet the Rome IV diagnostic criteria for diarrhea-predominant irritable bowel syndrome;
2. Aged between 18 and 65 years old (inclusive), male or female;
3. HAMA assessment ≥ 14 points or HAMD assessment ≥ 17 points
Exclusion Criteria:
1. Patients with severe cardiovascular and cerebrovascular diseases (such as myocardial infarction, cerebral infarction, coronary heart disease, etc.);
2. Abnormal liver and kidney function (ALT or AST \> 1.5 times the upper limit of normal, or T-Bil \> 1.5 times the upper limit of normal, or Cr more than the upper limit of normal), hematopoietic system diseases and tumors;
3. Patients with a history of abdominal surgery (except appendectomy and cholecystectomy);
4. Previous diagnosis of organic diseases of the digestive system, such as inflammatory bowel disease, intestinal tuberculosis, etc., or still associated with peptic ulcer, infectious diarrhea, etc.;
5. Previous diagnosis of diseases similar to irritable bowel syndrome symptoms, such as eosinophilic enteritis, microscopic colitis (including collagen colitis and lymphocytic colitis), lactose intolerance, malabsorption syndrome;
6. Previous diagnosis of non-intestinal digestive system diseases, such as tuberculous peritonitis, gallstones, cirrhosis, chronic pancreatitis;
7. Previous diagnosis of diseases affecting the digestive tract function, such as hyperthyroidism or hypothyroidism, endometriosis, autoimmune diseases, diabetes, etc.;
8. 4\. Patients who have taken drugs with bleeding risk or increased bleeding risk before treatment;
9. 4\. Patients who have taken antidepressant drugs and psychotropic drugs before treatment;
10. 4\. Use drugs that affect gastrointestinal motility and function, such as prokinetic drugs, anticholinergic drugs, calcium channel blockers, 5-HT receptor agonists/antagonists, antidiarrheal agents, antacids, intestinal bacteria modulators and antibiotics;
11. Allergic constitution;
12. Pregnant and lactating women; Others that may affect study compliance or adversely affect the results as judged by the investigator.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT05311293
Study Brief:
Protocol Section:
NCT05311293