【Indications】
Acute and chronic diarrhea caused by acute non-specific infection, intestinal flora imbalance caused by antibiotics, chronic liver disease and other reasons, and related acute and chronic diarrhea and dyspepsia.
【R&D and Commercial Production of CLOBICO】
In 1996, Clostridium butyricum and Bifidobacterium infantis were screened and obtained;
In 1997, the strains were deposited in the China General Microbiological Culture Collection Center;
In 1999, the clinical trial approval was obtained, and the phase I, II and III clinical trials were initiated;
In 2001, the new drug certificate was obtained;
In 2002, the production approval was obtained;
In 2008, the stability study of cold-chain transportation under intermittent ambient temperature was carried out;
In 2009, the filing of intermittent temperature during cold-chain transportation was completed, and the package insert was noted that "in case of intermittent refrigeration temperature during transportation, the shelf life should not exceed 7 days, and light and heat should be avoided".
In 2010, a multicenter randomized controlled clinical trial of Combined Clostridium Butyricum and Bifidobacterium Powder in the prevention of antibiotic-associated diarrhea in children with pneumonia was carried out, and the results confirmed that: Combined Clostridium Butyricum and Bifidobacterium Powder could effectively reduce the risk of AAD in hospitalized children with pneumonia, and the incidence of AAD in the test group was 7.8% (13/193) within 7 days of observation;