Last updated: January 13, 2023
Sponsor: Mei Han
Overall Status: Active - Not Recruiting
Phase
2/3
Condition
Colic
Gastrointestinal Diseases And Disorders
Lactose Intolerance
Treatment
N/AClinical Study ID
NCT05687435
CYNT-2022-12
Ages 18-65 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Meet IBS-D Rome IV diagnostic criteria;
- Age between 18 and 65 years old (including boundary value), regardless of gender;
- IBS symptom severity scale (IBS-SSS) scores > 175 points;
- The weekly average score of abdominal pain in screening period is ≥ 3 points (The mostsevere 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 (Bristolstool scale) is type 6 or 7 ≥ 2 in a week;
- Patients who voluntarily accept the program's plan of the project and signs theinformed consent form.
Exclusion
Exclusion Criteria:
- Patients with serious or unstable heart, liver, kidney, immune, endocrine system andother diseases or malignant tumors;
- Patients are affected by factors such as intellectual disorder, mental disorder andlanguage;
- Patients with gastrointestinal organic diseases or with malignant tumors, such aspancreatitis, intestinal adenoma (excluding polypectomy for more than half a month),intestinal diverticulum, colon or rectal cancer, inflammatory bowel disease,intestinal tuberculosis, etc;
- Other diseases (such as hyperthyroidism, diabetes, chronic renal insufficiency,nervous system diseases, etc.) that affect digestive tract dynamics;
- Complicated with tuberculosis peritonitis, gallstones, cirrhosis, chronic pancreatitisand other gastrointestinal diseases;
- Allergic constitution or allergic to the components of the studied drug;
- Pregnant or lactating women, and women with recent fertility plans;
- Previous abdominal or pelvic surgery, such as cholecystectomy;
- Patients with positive fecal occult blood;
- During the screening period, drugs that affect gastrointestinal motility and functioncannot be stopped, including parasympathetic inhibitors, such as scopolamine,atropine, belladonna, etc; Muscle relaxants, such as succinylcholine; Antidiarrhealagents such as loperamide, smecta, etc; Opioid preparations, etc;
- Those who use probiotics (except those who eat yoghurt) or antibiotics within 8 weeksbefore enrollment in the study;
- IBS drugs (except polyethylene glycol and loperamide) were used within 3 months beforethe study;
- Those who regularly drink alcohol within 6 months before screening, i.e., drink morethan 14 units of alcohol every week (1 unit=360 mL beer or 45 mL liquor or 150 mL winewith 40% alcohol);
- Those who have participated in or are currently participating in other clinical trialswithin 1 month before screening;
- The researcher believes that there are patients who are not suitable for inclusion.
Study Design
Total Participants: 240
Study Start date:
January 30, 2023
Estimated Completion Date:
April 30, 2024