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:
2025-12-24 @ 10:31 PM
Ignite Modification Date:
2025-12-24 @ 10:31 PM
NCT ID:
NCT05687435
Eligibility Criteria:
Inclusion Criteria:
1. Meet IBS-D Rome IV diagnostic criteria;
2. Age between 18 and 65 years old (including boundary value), regardless of gender;
3. IBS symptom severity scale (IBS-SSS) scores \> 175 points;
4. The weekly average score of abdominal pain in screening period is ≥ 3 points (The most severe abdominal pain in the past 24 hours every day, the pain score was 11 grades (0-10), NRS-11; Also the number of days of the stool character classification (Bristol stool scale) is type 6 or 7 ≥ 2 in a week;
5. Patients who voluntarily accept the program's plan of the project and signs the informed consent form.
Exclusion Criteria:
1. Patients with serious or unstable heart, liver, kidney, immune, endocrine system and other diseases or malignant tumors;
2. Patients are affected by factors such as intellectual disorder, mental disorder and language;
3. Patients with gastrointestinal organic diseases or with malignant tumors, such as pancreatitis, intestinal adenoma (excluding polypectomy for more than half a month), intestinal diverticulum, colon or rectal cancer, inflammatory bowel disease, intestinal tuberculosis, etc;
4. Other diseases (such as hyperthyroidism, diabetes, chronic renal insufficiency, nervous system diseases, etc.) that affect digestive tract dynamics;
5. Complicated with tuberculosis peritonitis, gallstones, cirrhosis, chronic pancreatitis and other gastrointestinal diseases;
6. Allergic constitution or allergic to the components of the studied drug;
7. Pregnant or lactating women, and women with recent fertility plans;
8. Previous abdominal or pelvic surgery, such as cholecystectomy;
9. Patients with positive fecal occult blood;
10. During the screening period, drugs that affect gastrointestinal motility and function cannot be stopped, including parasympathetic inhibitors, such as scopolamine, atropine, belladonna, etc; Muscle relaxants, such as succinylcholine; Antidiarrheal agents such as loperamide, smecta, etc; Opioid preparations, etc;
11. Those who use probiotics (except those who eat yoghurt) or antibiotics within 8 weeks before enrollment in the study;
12. IBS drugs (except polyethylene glycol and loperamide) were used within 3 months before the study;
13. Those who regularly drink alcohol within 6 months before screening, i.e., drink more than 14 units of alcohol every week (1 unit=360 mL beer or 45 mL liquor or 150 mL wine with 40% alcohol);
14. Those who have participated in or are currently participating in other clinical trials within 1 month before screening;
15. The researcher believes that there are patients who are not suitable for inclusion.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT05687435
Study Brief:
Protocol Section:
NCT05687435