infant acute diarrhea
Conditions
Interventions
Acute diarrhea-Control:Take placebo
Acute diarrhea-CCFM1078:Take CCFM1078
Acute diarrhea-CCFM1269:Take CCFM1269
Sponsors
Department of Gastroenterology, Children's Hospital of Shanghai
Eligibility
Sex/Gender
All
Age
No minimum to 3 Years
Inclusion criteria
Inclusion criteria: (1)Age 0-3 years old, gender unlimited; (2) Meet the diagnosis of acute diarrhea: defecation 3 or more times a day, the duration of not more than 2 weeks, increased frequency of stool or changes in stool characteristics in the past 24 hours, may be accompanied by nausea, vomiting, abdominal pain or fever and other systemic symptoms; Bristol type 6-7. (3) The patient's family members have good communication skills and can follow the requirements of the study protocol to complete the records and follow-up. The patient's family members signed informed consent and were willing to participate in the clinical trial.
Exclusion criteria
Exclusion criteria: (1) Chronic and prolonged diarrhea; (2) Allergic or adverse reactions to bifidobacterium brevis CCFM1078 and Bifidobacterium longum CCFM1269 and similar drugs; (3) There are serious metabolic diseases, serious chronic cardiovascular and cerebrovascular, lung, liver, kidney and other chronic diseases, combined with disease medication may affect gastrointestinal motility. (4) organic gastrointestinal diseases (inflammatory bowel diseases, tumors, etc.); (5) Long-term abuse of laxatives or systemic corticosteroids; (6) The guardian of the subject refuses to sign the informed consent, and the follow-up compliance is poor; (7) Participants in clinical trials of other investigational drugs in the past 12 weeks; Use antimicrobials, probiotics, laxatives, and other medications that may affect bowel movements within 4 weeks before the start of the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Fecal 16S rDNA sequence;Short chain fatty acids;Inflammatory factors;Neurotransmitters;Immunoglobulin; | — |
Secondary
| Measure | Time frame |
|---|---|
| Stool routine examination;Blood routine examination;Blood biochemical;Faecal calprotectin;urine routine examination; | — |
Countries
China
Contacts
Public ContactZhang Ting
Department of Gastroenterology, Children's Hospital of Shanghai
Outcome results
None listed