Acute diarrhea in children
Conditions
Interventions
High-dose test drug group:Three live tablets of bifidobacterium were taken orally, three times a day
Medium-dose group of the test drug:Two tablets of bifidobacterium tetrad and one tablet of tetrad and placebo were taken orally, three times a day
Low-dose group of the test drug:One bifidobacterium tetrad tablet and two tablet placebo were administered three times a day
control group:Three tablets of bifidobacterium tetrad placebo three times a day
Sponsors
Beijing Children's Hospital affiliated to Capital Medical University
Eligibility
Sex/Gender
All
Age
1 Years to 5 Years
Inclusion criteria
Inclusion criteria: 1. Age: 1 year to 5 years (12 months age: <72 months), gender is not limited; 2. Meets the diagnostic criteria for pediatric diarrhea: the frequency of bowel movements has increased compared to before, with at least 3 times in 24 hours, accompanied by changes in the characteristics of the stool (loose or watery stool, specifically type 6 or 7 according to the Bristol stool chart). 3. Mild and medium-sized diarrhea with a duration of no more than 72h; 4. The informed consent process shall comply with the regulations, and the legal guardian of the tested children shall voluntarily sign the informed consent
Exclusion criteria
Exclusion criteria: 1. Severe diarrhea (severe gastrointestinal symptoms, severe dehydration, and / or significant symptoms of systemic poisoning), 2. Frequent and severe vomiting, dysphagia, and failure to take drugs on time; 3. Invasive bacterial infectious diarrhea/dysentery-like diarrhea, such as visible mucus, purulent blood stools, or fecal microscopy showing pus/white blood cells >= 5 per field and/or red blood cells >= 3 per field; 4. Diarrhea caused by special pathogens such as cholera, dysentery, amoebic dysentery, typhoid, paratyphoid, parasitic infections, congenital megacolon, short bowel syndrome, congenital diarrhea, malabsorption syndrome (like disaccharidase deficiency), as well as diseases caused by anatomical defects or congenital factors, inflammatory bowel disease, pancreatic insufficiency, cystic fibrosis, endocrine diseases, tumors, human immunodeficiency virus (HIV) infection, and immunodeficiency diseases, and drug-related diarrhea caused by antibiotics and other factors; 5. Diarrhea treatment has been applied within the 24 hours before screening, and there has been significant improvement (such as racecadotril, zinc preparations, montmorillonite powder, probiotics, traditional Chinese medicine preparations, etc. Symptomatic treatments like hypotonic rehydration salts are not included. Significant improvement means that the Bristol stool form scale score has reduced by at least one level); 6. Long-term oral or intravenous administration of glucocorticoids or immunosuppressive drugs; 7. Patients treated with antibiotics or probiotic drugs for two weeks before screening; 8. Other diseases that require antibiotic treatment; 9. Severe malnutrition (length / height and weight <-3SD, Appendix 1), children with immunodeficiency,May seriously affect the self-limitation of the disease course; 10. Severe primary diseases, such as heart, liver, kidney, digestive and hematopoietic system; 11. Allergy to investigational drugs and their ingredients; 12. Other circumstances as judged by the investigator; 13 Have participated in any clinical trial within 30 days before the trial, or planned to participate in other clinical trials during the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Rate of diarrhea withdrawal within 72 hours after trial administration ("diarrhea withdrawal" was defined as 2 consecutive episodes of formed stool or no defecation for 24 hours, and formed stool was defined as bristol fecal trait type type 1 to 4) ; | — |
Secondary
| Measure | Time frame |
|---|---|
| The rate of diarrhea regression within 24h and 48h after drug administration ;72h efficacy evaluation (total effective and significant efficiency) ;Antidiarrheal onset time after medication ;Duration of diarrhoea symptoms after medication;Number of daily bowel movements after medication;Refluid every 24 hours after administration (including Ors) ;Body weight change at 72h after drug administration ;Proportion of patients with revised vesikari 9 (moderate to severe gastroenteritis) ;Proportion of patients requiring hospital admission and days of hospital stay;Proportion of patients requiring admission and change of fecal flora imbalance in each group before and after 3 days of hospitalization ;Proportion of subjects with remedial antidiarrheal medication during the trial ;Safety indicators: vital signs, laboratory tests (blood, urine, stool routine, electrolysis Quality, liver and kidney function, electrocardiogram, c-reactive protein), adverse events (ae), and severe adverse events Number of cases of an event (sae) ; | — |
Countries
China
Contacts
Public ContactWu Jie
Beijing Children's Hospital affiliated to Capital Medical University
Outcome results
None listed