None listed
Conditions
Interventions
Drug : If the suitability of the subjects is confirmed, the subjects are randomly assigned 1:1 to the test group and the control group, and BiscanN Powder drugs and placebo are administered if assigne
Sponsors
Binex Co., Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1)Children under 12 years of age as of screening time 2)Those who have experienced diarrhea* symptoms within the last 48 hours based on the time of screening. *Diarrhea: The case where an unformed stool has been discharged more than 3 times/24 hours is defined as diarrhea. Unformed stool refers to a dilute stool or watery stool and falls under Bristol Stool Scale Type 6 or 7. 3)Subjects including parents (or legal guardians) decide to participate in the clinical trial and agree in writing after hearing and understanding the purpose, content, characteristics of clinical trial drugs, and expected abnormal cases
Exclusion criteria
Exclusion criteria: 1)If diarrhea symptoms persist beyond the previous 48 hours based on the time of screening 2)If diarrhea is accompanied by a fever of 39? or higher 3)Diarrhea accompanied by stools mixed with blood 4)If you have taken or are currently taking intestinal medicine, antidiarrheal medicine, antidiarrheal medicine, antidiarrheal medicine, etc. to improve symptoms of diarrhea within 48 hours based on the time of screening 5)If antibiotics or antimicrobials were taken within one week prior to screening 6)If you have diarrhea at the time of screening due to the deterioration of chronic gastrointestinal disease (e.g., diarrhea-type irritable bowel syndrome (IBS-D), inflammatory bowl disease (inflammatory bowl disease), or pancreatic exocrine inadequacy) 7)In the case of genetic problems such as galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption in the interview 8)In case of drug hypersensitivity to probiotics* preparations *Lactobacillus (L. acidophilus, L. casei, L. gasseri, L. delbrueckii ssp. bulgaricus, L. helveticus, L. fermentum, L. paracasei, L. plantarum, L. reuteri, L. rhamnosus, L. salivarius), Lactococcus (Lc. lactis), Enterococcus (E. faecium, E. fecalis), Streptococcus (S. thermophilus), Bifidobacterium (B. bifidum, B. breve, B. longum, B. animalis ssp. Lactis) and other medicines, health functional foods and foods containing probiotics 9)If the tester deems it inappropriate to participate in this clinical trial due to endocrine and metabolic diseases (diabetes, thyroid diseases, etc.) that are not controlled by symptoms or drugs 10)If the tester deems it inappropriate to participate in the clinical trial due to a serious or uncontrolled psychiatric condition 11) Cases of serious internal and neurological diseases (cirrhosis, congestive heart failure, unstable angina, asthma, chronic renal failure, nephrotic syndrome, Parkinson's disease, etc.) that may affect clinical trials 12)If you are currently taking immunosuppressants 13)If you have participated in other clinical trials within 2 months prior to screening 14)For reasons other than the above selection and exclusion criteria, the person in charge of testing (or the person in charge of testing who has been delegated) determines that he/she is not suitable for this clinical trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Response rate on the 5th day after administration of clinical trial drug | — |
Secondary
| Measure | Time frame |
|---|---|
| The time required for formed feces to appear after administration of a clinical trial drug;Change in the number of bowel movements per day compared to baseline (screening time) after clinical trial drug administration;Change in the number of vomiting per day compared to baseline (screening time) after clinical trial drug administration | — |
Countries
Korea, Republic of
Contacts
Public ContactRyoo Eell
Gachon University Gil Medical Center
Outcome results
None listed