Irritable bowel syndrome with diarrhea
Conditions
Interventions
Test group:SK08 Live Bacteria Powder
Placebo group:SK08 Viable Bacteria Powder Mimic
Sponsors
The First Affiliated Hospital,Sun Yat-sen University
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Voluntarily sign informed consent, be able to comply with the protocol and be able to carry out related procedures, including the completion of diary cards during the induction period and throughout the study period. 2. Age between 18 and 70 years old (including both values, based on the date of signing the Master Informed consent), regardless of gender. 3. IBS-D patients with clinical symptoms meeting the Rome IV definition, that is, the course of disease for at least 6 months, repeated abdominal pain in the past 3 months, an average of at least 1 day per week, combined with two or more of the following conditions: (1) Abdominal pain is related to defecation; (2) Abdominal pain accompanied by changes in the frequency of defecation; (3) Abdominal pain accompanied by changes in fecal characteristics. When abnormal stool occurred in the last 3 months, the proportion of abnormal stool was >25% for Bristol fecal trait type 6 or 7, and 5mm or the number of intestinal polyps was >3. After endoscopic treatment, the diameter of residual intestinal polyps was =5mm and the number of intestinal polyps was =3, and the researchers determined that they could be included in the group. 5. Colonoscopy or endoscopy should be performed at least 4 weeks from the introduction period, and IBS symptoms still occur before the introduction period. 6. During the introduction period, the average number of days with type 6 or type 7 faecal traits per week was >=4 days, and the average NRS score (the highest score within 24 hours) of daily abdominal pain intensity on days with type 6 or type 7 faecal traits was >=3.0. 7. Patients completed diary cards at least 5 days in the 1 week before randomization (D-7 to D-1) and at least 10 days in the 2 weeks before randomization (D-14 to D-1). 8. The patient had not used any relief drugs or analgesics in the 14 days prior to randomization. 9.. During the period from the signing of the master informed consent to the end of the final study visit, patients agreed to maintain their usual diet and lifestyle, such as no changes in dietary structure or exercise patterns.
Exclusion criteria
Exclusion criteria: 1. Patients with constipated, mixed and amorphous IBS. 2. Patients with organic gastrointestinal diseases were excluded from the following conditions: superficial gastritis, grade I erosive gastritis, chronic atrophic gastritis found by endoscopy but judged by the researchers to be eligible for admission (for example, no mucosal erosion or bleeding under endoscopy, and no abdominal distension, epigastral pain, acid reflux and other symptoms). 3. Parenteral diseases of the digestive system such as tuberculous peritonitis, pancreatitis, cirrhosis, and biliary tract diseases are present, except for fatty liver disease that has not progressed to hepatitis, and gallstones that lack related symptoms. 4. Known to have lactose intolerance and celiac disease. 5. There are other systemic diseases, including serious diseases of the heart, lungs and kidneys, malignant tumors, autoimmune diseases, metabolic diseases (such as diabetes, diseases affecting thyroid function), reproductive system diseases (such as non-physiological ovarian cysts, endometriosis, severe dysmenorrhea requiring medical treatment), etc. 6. Previous history of abdominal and pelvic surgery, except appendectomy, caesarean section and tubal ligation, but no intestinal complications, hernia repair. 7. Patients with a previously diagnosed psychiatric disorder or moderate to severe depression or generalized anxiety disorder requiring medication (PHQ-9=10 or GAD-7=10 during screening). 8. Fecal examination results showed occult blood (+) and above (except for cases caused by hemorrhoids or female menstrual periods) or white blood cells (+) and above, and were judged by the investigator to be clinically significant. 9. People who are positive for antibodies against hepatitis C virus (HCV), or human immunodeficiency virus (HIV), or syphilis, or hepatitis B surface antigen (HBsAg) and need antiviral therapy at the screening stage. 10. Laboratory tests showed significant abnormalities that the investigator determined could compromise the patient's safety by participating in the study, including but not limited to: (i) creatinine >=1.5 times the upper limit of normal (ULN); (ii) AST >=2 times upper limit of normal (ULN) and/or ALT >=2 times upper limit of normal (ULN) and/or total bilirubin >=1.5 times upper limit of normal (ULN). 11. Unexplained weight loss, anemia, fever, or jaundice before screening. 12. A history of drug or alcohol abuse. 13. Even with the help of liquids, patients are unable to take oral solid dosage forms. 14. Allergic to experimental drugs, rescue drugs and their ingredients. 15. During the trial, drugs that affect gastrointestinal movement and function cannot be discontinued, It includes antibiotics (such as erythromycin), drugs that regulate intestinal microecology (such as bifidobacterium), parasympathetic inhibitors (such as scopolamine, atropine, belladona, etc.), muscle relaxants (such as succincholine), antidiarrheal agents (such as loperamide, montmorillite powder, etc.), opioids, drugs that inhibit gastric acid secretion, etc. 16. A woman who is pregnant or breastfeeding. 17. At the time of the trial, both the patient and his partner were unable or unwilling to use reliable contraception to prevent pregnancy, or the female or male patient's partner had a recent pregnancy plan. 18. Have participated in any clinical trial and used the experimental drug or device within 3 months prior to signing the informed consent. 19. The patient had previously participate
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Compound weekly response rate (1-12 weeks); | — |
Secondary
| Measure | Time frame |
|---|---|
| Compound weekly response rate (1-8 weeks, 1-4 weeks, 5-8 weeks, 9-12 weeks);Clinical laboratory examination: blood routine, blood biochemistry, urine routine and stool examination.;12-lead electrocardiogram.;Adverse Event and Serious Adverse Event Monitoring;IBS response rate;Change from baseline in the frequency of type 6/7 stools per week;Abdominal distension week response rate;Weekly response rate of fecal traits;Abdominal pain weekly response rate;Change from baseline in type 6/7 stool days per week;Physical examination: including general condition, mucocutaneous, lymph node, head and neck, chest, abdomen, spine/extremities, and other examinations.;Changes of IBS-QOL scores;Changes of irritable bowel syndrome severity scale;Pregnancy test for women of childbearing age.;Vital signs: body temperature, pulse, respiratory rate, sitting blood pressure (systolic and diastolic).;Change from baseline in the weekly mean of the highest abdominal distension score after treatment;Change from baseline in the weekly mean of the highest abdominal pain intensity score after treatment; | — |
Countries
China
Contacts
Public ContactXiao Yinglian
The First Affiliated Hospital,Sun Yat-sen University
Outcome results
None listed