Irritable Bowel Syndrome
Conditions
Interventions
Experimental group1:Live SK08 powder 1-25×10^8CFU, BID
Experimental group2:Live SK08 powder 1-25×10^9CFU, BID
control group:placebo
Sponsors
The First Affiliated Hospital of Sun Yat-Sen University
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1.Signed the informed consent form voluntarily, be able to comply with the protocol and perform procedures; 2.Aged 18 to 70 years (according to the day of signing the ICF), no gender limit; 3.Diagnosed with IBS-D according to Rome IV definition; 4.In the run-in period (that is, with in 14±3 days before intervention), the days when the type 6 or 7 stools happened according to Bristol stool typing, are no less than 2 per week, and the average value of the NRS score of abdominal pain (the highest score within 24 hours) is no less than 3.0 in these days; 5.The patient agrees to not make any new significant changes in lifestyle (for example, starting a new diet, or changing the usual exercise pattern) that may affect IBS-D symptoms from the time the ICF is signed to the end of the last trial visit; 6.Patients with a normal colonoscopy report (observed to the ileocecal area and image recording) in Grade 3A hospital within 12 months, and then the disease recurred, including patients with colon polyps recurring within one year after endoscopic treatment (diameter <= 5mm, the number is <=3); or patients with a normal colonoscopy report in Grade 3A hospital before screening, but a history of bowel preparation, they can only be enrolled in the next attack.
Exclusion criteria
Exclusion criteria: 1.Diagnosed as IBS-C, IBS-M or IBS-U; 2.Patients with gastrointestinal organic diseases: except for patients with superficial gastritis and grade I erosive gastritis; for patients with chronic atrophic gastritis reported under endoscope, patients whose microscopic results are no clinical significance based on the investigators clinical judgment can also be enrolled (such as no mucosal erosion, bleeding, no upper gastrointestinal symptoms such as upper abdominal fullness, pain, sour regurgitation); 3.A history of abdominal and pelvic surgery, such as cholecystectomy, etc. (except for patients without intestinal complications such as intestinal obstruction after appendectomy, hernia repair or caesarean section, and patients with intestinal polyps =1.5 x ULN; (2) Chronic liver disease and/or hepatic insufficiency: defined as AST>=1.5 x ULN and/or ALT>=1.5 x ULN and/or total bilirubin >= 1.5 x ULN. 9.A history of mental illness, moderate to major depressive disorder or anxiety disorder (PHQ-9>=10, GAD-7>=10 in screening period); 10.Unexplained emaciation, anemia, fever, or jaundice before screening 11.A history of drug abuse or alcohol abuse; 12.Allergic to the investigational medicinal product, rescue drug and their ingredients; 13.Drugs that affect gastrointestinal motility and function cannot be discontinued in the trial, including: antibiotics, such as erythromycin; drugs that regulate intestinal microecology, such as bifidobacterium; parasympathetic inhibitors, such as scopolamine, atropine, belladonna, etc; muscle relaxants, such as succinylcholine; antidiarrheal agent, such as loperamide, Smecta, etc; opiates; drugs that inhibit gastric acid secretion, etc; 14.Woman who are pregnant or lactating; 15.Both subject and his partner cannot take reliable contraceptive measures for contraception during the trial; or female subject or the male subjects partner has a pregnancy plan in the near future; 16.Have participated in any clinical trial within 3 months before signing the informed consent; 17.Not suitable to participate in this clinical trial according to the judgement of the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Compound weekly response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Weekly response rate of fecal traits;Weekly response rate of abdominal pain;Changes in the Irritable Bowel Syndrome Symptom Severity Scale scores from baseline;Changes in the Irritable Bowel Syndrome Quality of Life scores from baseline;Percentage and amount of subjects who used rescue drugs to treat IBS during the trial; | — |
Countries
China
Contacts
Public ContactChen Minhu
The First Affiliated Hospital of Sun Yat-Sen University
Outcome results
None listed