None listed
Conditions
Interventions
Drug : Once the subject's suitability is confirmed, the subject is randomly assigned 1:1 to the test group and the control group, and if assigned to the test group, BiscanN Powder real drug and placeb
Sponsors
Binex Co., Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) Adults aged 19 years or older at the time of screening (2) Those who experienced diarrhea* symptoms within the past 48 hours at the time of screening *Diarrhea: Diarrhea is defined as unformed stool discharged 3 or more times/24 hours. Unformed stool refers to loose stool or watery stool and corresponds to Bristol Stool Scale Type 6 or 7. (3) If the subject has received sufficient explanation about the purpose and content of this trial, the characteristics of the clinical trial drug, expected adverse events, etc., and has decided to participate in the clinical trial and has given written consent
Exclusion criteria
Exclusion criteria: (1) If diarrhea symptoms persist for more than 48 hours prior to screening (2) If diarrhea is accompanied by a fever of 39? or higher (3) If diarrhea is accompanied by bloody stool (4) If you have taken or are currently taking antidiarrheal agents, anti-diarrheal agents, or antispasmodics to improve diarrhea symptoms within 48 hours prior to screening (5) If you have taken antibiotics or antibacterial agents within 1 week prior to screening (6) If you have diarrhea symptoms due to exacerbation of chronic gastrointestinal disease (e.g., irritable bowel syndrome-diarrhea (IBS-D), inflammatory bowel disease, or pancreatic exocrine insufficiency) at the time of screening (7) If galactose intolerance, Lapp lactase deficiency, or glucose-galactose In case of genetic problems such as malabsorption (glucose-galactose malabsorption) (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) Severe or uncontrolled endocrine and metabolic diseases (diabetes, thyroid) (10) If the subject is judged to be unsuitable for participation in this clinical trial due to a severe or uncontrolled psychiatric disorder (11) If the subject is judged to be unsuitable for participation in this clinical trial due to a serious internal or neurological disease (liver cirrhosis, congestive heart failure, unstable angina, asthma, chronic renal failure, nephrotic syndrome, Parkinson's disease, etc.) that may affect the clinical trial (12) If the subject is currently taking immunosuppressants (13) If the subject is a woman or man who does not agree to use a medically acceptable method of contraception from the time of consent until the end of participation in this study (? Medically acceptable method of contraception: use of an intrauterine device with a proven pregnancy failure rate in the spouse (or partner), simultaneous use of barrier contraception (for men or women) and spermicide, surgery (vasectomy, salpingectomy/ligation, hysterectomy) of the subject or partner (14) If the subject has participated in another clinical trial within 2 months prior to screening If you have ever participated (15) Those who are judged by the principal investigator (or the person in charge of the investigation) to be unsuitable for this clinical trial for reasons other than the above selection/exclusion criteria
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;Improvement of subjective symptoms after clinical trial drug administration | — |
Countries
Korea, Republic of
Contacts
Public ContactChoi Chang Hwan
Chung-Ang Univerisity Hospital
Outcome results
None listed