Diarrhoeal irritable bowel syndrome
Conditions
Interventions
Group 1:KEIB047 Probiotics + Otium bromide tablets placebo
Group 2:KEIB047 Probiotics + Otium bromide tablets
Group 3:KEIB047 Probiotics placebo + Otium bromide tablets
Sponsors
The First Affiliated Hospital of Nanchang University
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1.According to the Rome IV and 2020 consensus of Chinese experts on irritable bowel syndrome, the diagnostic criteria for IBS are as follows: recurrent abdominal pain, bloating, and discomfort, with symptoms occurring for at least 6 months before diagnosis, and an average of at least 1 day per week in the past 3 months meeting at least 2 of the following criteria. a) Related to defecation; b) Accompanied by changes in bowel frequency; c) Accompanied by changes in fecal characteristics or appearance. 2. According to the Rome IV fecal classification criteria for IBS, IBS classification needs to be determined based on at least 2 weeks of stool diary. The diagnostic criteria for IBS (IBS-D) mainly characterized by diarrhea are: more than a quarter (25%) of the fecal type is Bristol 6 or 7, and less than a quarter (25%) of the fecal type is Bristol 1 or 2; 3. According to the inclusion criteria of patients in the clinical research guidelines for IBS-D new drugs by the US FDA, during the screening period, there should be at least 2 days per week and at least one stool trait classification of type 6 or 7 per day, and the NRS score of daily abdominal pain intensity recorded based on the past 24 hours (evaluated using 0 to 10 points), with an average weekly abdominal pain intensity of>=3.0 points or an average weekly abdominal distension degree of>=3.0 points, The average level of discomfort in the abdomen is>=3.0 points; 4. The patient agrees not to make any new or significant lifestyle changes that may affect IBS-D symptoms from signing the ICF until the end of the last trial visit (such as starting a new diet or changing normal exercise patterns); 5. There must be a colonoscopy examination report from a tertiary A hospital within 12 months and it must be normal (observed to the ileocecal area, and Boston score>=6 points); If there is a colon polyp (diameter<=5mm), it is considered normal; 6. Considering the impact of intestinal preparation, patients who have undergone colonoscopy in the past month have been postponed to one month after the end of colonoscopy for enrollment; 7. Age range from 18 to 70 years old (including 18 and 70 years old), regardless of gender; 8. Sign an informed consent form.
Exclusion criteria
Exclusion criteria: 1. Patients with constipated, mixed, and amorphous IBS; 2. Those who defecate more than or equal to 5 times a day; 3. Intestinal polyposis; 4. Colon polyps have been removed in the past month; 5. If there are any of the following situations during the screening period: a) Renal function: blood creatinine (Scr)>=1.5 times the upper limit of normal value (ULN); b) Liver function: glutamic oxaloacetic transaminase (AST)>=1.5 times the upper limit of normal value (ULN) or glutamic pyruvic transaminase (ALT)>=1.5 times the upper limit of normal value (ULN) or total bilirubin>=1.5 times the upper limit of normal value (ULN); c) Abnormal stool routine results: fecal occult blood (++) or white blood cells (+); d) Individuals with obvious abnormalities in electrocardiogram; 6. Have a history of active peptic ulcer and esophagitis; 7. Individuals with a history of inflammatory bowel disease, intestinal tuberculosis, tuberculous peritonitis, liver cirrhosis, etc; 8. Have undergone major surgeries on the stomach, liver, pancreas, or intestines or have a history of perforation (excluding appendicitis, gallbladder, or inguinal hernia); 9. Antibiotics, digestive enzyme preparations, anti muscarinic drugs, gastrointestinal motility enhancing drugs, analgesics, neurotransmitter regulating drugs (such as tricyclic antidepressants), probiotics (including yogurt, etc.), other microecological agents, dietary supplements or other drugs or products that affect gastrointestinal function were used within one month before the first administration; 10. If there is a significant change in dietary habits within one month before the first administration, such as starting to consume a fiber rich diet; 11. Have been diagnosed with other serious systemic diseases, including serious diseases of heart, lung, kidney, liver and other important organs, immune regulatory diseases, metabolic diseases (diabetes, thyroid diseases) or malignant tumors, reproductive system diseases such as ovarian cysts, endometriosis, etc; 12. Individuals with a history of drug or alcohol abuse; 13. Recent pregnant women (including both males and females), pregnant or lactating women; 14. Individuals who are allergic to samples or sample components; 15. Subjects with symptoms of convulsions or major mental disorders, difficulty in controlling their own actions, and inability to cooperate; 16. Participated in other clinical trials within 3 months before the first administration; 17. Subjects who are illiterate, unable to understand informed consent, and unable to sign informed consent forms on their own; 18. Patients deemed unsuitable by researchers.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Composite weekly response rate;Irritable Bowel Syndrome Severity Scale (IBS-SSS); | — |
Secondary
| Measure | Time frame |
|---|---|
| Quality of life score;Analysis of the intestinal flora;Weekly response rate of fecal traits;Weekly abdominal pain response rate;Weekly response rate for abdominal distension;Abdominal discomfort weekly response rate;Visceral Sensitivity Index;Hospital Anxiety Depression Score;Serum IL-6, IL-8, IL-10, TNFa levels;D-lactate, bacterial endotoxin, diamine oxidase content;Targeted metabolomics analysis; | — |
Countries
China
Contacts
Public ContactNonghua Lu
The First Affiliated Hospital of Nanchang University
Outcome results
None listed