The efficacy of Live Combined Bifidobacterium and Lactobacillus Tablets (Golden Bifid) in the treatment of diarrhea-predominant irritable bowel syndrome:a randomized, double-blind, placebo-controlled, multicenter clinical trial
- Conditions
- irritable bowel syndrome
- Registration Number
- ChiCTR2400088770
- Lead Sponsor
- The First Medical Center, Chinese PLA General Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- All
- Target Recruitment
- Not specified
Only those who meet all the selection criteria can be selected:<br><br>1. The patient voluntarily participates and signs an informed consent form;<br><br>2. Male and female participants aged 18-70 (including 18 and 70 years old);<br><br>3. The Rome IV diagnostic criteria clearly diagnose diarrhea-predominant irritable bowel syndrome (IBS-D), which means that more than 1/4 of stool characteristics (calculated by days) are Bristol fecal type 6 or 7, and less than 1/4 of stool characteristics are Bristol fecal type 1 or 2;<br><br>4. Before enrollment, patients should complete a symptom diary card for at least 12 days; Complete symptom diary cards for at least 7 consecutive days within 10 days prior to enrollment;<br><br>5. Baseline (defined as the most recent 7-day diary record prior to enrollment): The average daily highest abdominal pain score of patients is = 3.0 (11-point NRS score), and fecal characteristics are classified as type 6 or type 7 at least 2 days per week;<br><br>6. Colonoscopy examination reports from domestic tertiary hospitals within two months or three years that are normal, or abnormal results that the researcher deems to have no clinical significance.<br><br>
<br>Exclusion criteria<br><br>If one criterion is met, it will be excluded:<br><br>1. Have a history of hereditary diseases;<br><br>2. Having organic intestinal diseases, such as inflammatory bowel disease, intestinal tuberculosis, or other organic diseases;<br><br>3. Diseases that are easily confused with IBS symptoms, such as endometriosis, malabsorption syndrome, celiac disease, lactose intolerance, and gallstones;<br><br>4. Previous history of abdominal and pelvic surgeries, such as cholecystectomy (excluding those who have undergone appendectomy for more than 6 months, cesarean section for 1 year and have completed lactation, and endoscopic treatment for intestinal polyps for more than 2 months);<br><br>5. Patients with chronic pancreatitis, tumors, peptic ulcers, tuberculous peritonitis, chronic liver disease, cirrhosis, and other non intestinal digestive system diseases (B-ultrasound diagnosis of chronic cholecystitis patients can be included if there is no typical biliary colic);<br><br>6. Have other serious systemic diseases, including serious diseases of heart, lung, kidney and other important organs, immune regulatory diseases, metabolic diseases (diabetes, hyperthyroidism or hypothyroidism) or malignant tumors;<br><br>7. Abnormal stool routine results: fecal occult blood (+) or red blood cells (+) or white blood cells (+);<br><br>8. Tumor markers CEA and CA199 are positive, and the researcher determines that they have diagnostic significance;<br><br>9. If there are significant abnormalities in laboratory tests that the researcher deems unsuitable to participate in and complete the study:<br><br>a) Hemoglobin < 1 × LLN;<br><br>b) Serum creatinine = 1 × ULN; Or creatinine clearance rate = 1 × LLN;<br><br>c) Abnormal liver function is defined as AST>1.5 x ULN and/or ALT>1.5 x ULN and/or total bilirubin>1.5 x ULN;<br><br>10. Patients with severe mental illness;<br><br>11. Before screening, abdominal pain mainly occurs at night, with unexplained weight loss, fever, jaundice, bloody or black stools, or BMI = 17kg/m2;<br><br>Obese patients with a BMI = 28kg/m2;<br><br>13. Drugs that have been used within 2 weeks prior to screening and/or that cannot be discontinued during the screening and treatment periods due to protocol restrictions;<br><br>14. Oral antibiotics have been used within one month prior to screening and/or cannot be discontinued during screening and treatment periods;<br><br>15. Have a history of drug or alcohol abuse (abnormal adaptation caused by alcohol or drug use can lead to clinical symptoms, with at least one of the following symptoms occurring within 12 months: A. Repeated use of drugs or alcohol resulting in negligence or failure in work, school, or family responsibilities; B. Repeated use of drugs or alcohol in a physically dangerous situation; C. Repeated occurrence of legal issues related to drug or alcohol use; D. Continuation of use of the substance despite social or interpersonal problems caused by drug or alcohol use) and allergies to the active ingredients and excipients of this drug in milk powder;<br><br>16. Significant lifestyle changes that may affect symptoms of diarrhea and abdominal pain during patient visits (such as starting a new diet or changing normal exercise patterns);<br><br>During the experiment, fermented foods containing live bacteria such as yogurt cannot be stopped;<br><br>18. Women who are pregnant, breastfeeding, or planning to conceive during the trial period;<br>19. Those who have been participating in or completing other clinical trials for less than 3 months and have been assessed by the researcher as unsuitab
Study & Design
- Study Type
- Interventional study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Effective rate of treatment for 4 weeks;Adverse event occurrence rate;Changes in gut microbiota;
- Secondary Outcome Measures
Name Time Method Percentage of subjects who experienced simultaneous improvement in abdominal pain and fecal characteristics during the fourth week of treatment;Response rate for improvement of abdominal pain and fecal characteristics after 4 weeks of treatment;Percentage of subjects with a decrease of = 30%, 40%, or 50% from baseline in the highest average weekly abdominal pain score;