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A Double-Blind, Randomized, Active Drug Comparative, Parallel-Group, Multi-Center Clinical Study to Evaluate the Safety and Efficacy of Probiotics (Bacillus licheniformis, Zhengchangsheng® capsule) in Patients with Diarrhea
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Jun Heo, Sung Kook Kim, Kyung Sik Park, Hye Kyung Jung, Joong Goo Kwon, Byung Ik Jang
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Intest Res 2014;12(3):236-244. Published online July 25, 2014
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DOI: https://doi.org/10.5217/ir.2014.12.3.236
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Abstract
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- Background/Aims
Bacillus Licheniformis, a probiotic used in the treatment of diarrhea, has been shown to suppress the growth of pathologic bacteria. This study was performed to assess the therapeutic efficacy and safety of Zhengchangsheng® (Bacillus Licheniformis) in comparison with another probiotic, Bioflor® (Saccharomyces Boulardii) for the treatment of diarrhea. MethodsPatients with diarrhea (n=158) were randomized to receive Zhengchangsheng® or Bioflor® for 5 days. The existence or non-existence of formed feces, changes in daily stool frequency, improvement of subjective symptoms, and changes in the severity of diarrhea were compared. ResultsOf the 158 full analysis set (FAS) patient population, 151 patients comprised the per protocol (PP) analysis. The rates of recovered to formed feces in the Bacillus and Saccharomyces groups were 91.0% vs. 95.0% in the FAS (P=0.326) and 90.5% vs. 96.1% in the PP analysis (P=0.169), respectively. The mean duration of diarrhea changing to formed feces was 3.15±1.10 days in the Bacillus group and 3.22±1.01 in the Saccharomyces group (P=0.695, FAS). The frequency of defecation, subjective symptoms, and degree of severe diarrhea were improved in both groups, however, there were no statistically significant differences between the 2 groups. Analysis of the 95% confidence intervals for the differences in the rate of recovery to formed feces between the 2 groups met the criteria for non-inferiority of Bacillus compared to Saccharomyces. No significant adverse events were observed during the study period. ConclusionsZhengchangsheng® is not inferior to Bioflor® in therapeutic efficacy and is a safe and useful therapeutic agent for the treatment of diarrhea.
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Citations
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Expression of Matrix Metallopreoteinases and Tissue Inhibitors of Metalloproteinases in Ulcerative Colitis
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Seong-Eun Kim, Sung-Ae Jung, Ki-Nam Shim, Hye Kyung Jung, Tae Hun Kim, Kwon Yoo
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Intest Res 2009;7(1):32-40. Published online June 30, 2009
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Abstract
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- Background/Aims
Ulcerative colitis (UC) is characterized by chronic non-specific inflammation in the mucosa and submucosa of the colon. Degradation of the extracellular matrix (ECM) is one of the major events during this process. Matrix metalloproteinases (MMPs) are important enzymes involved in the degradation of the ECM, and the activities of MMPs are controlled by its natural inhibitor, tissue inhibitor of metalloproteinases (TIMPs). This study was performed to determine the expression of MMPs and TIMPs in patients with UC. Methods: Twenty-nine patients with UC and 5 controls were included. Colonoscopic biopsies were obtained from the cecum, ascending colon, transverse colon, sigmoid colon, and rectum in each patient. The mRNA levels of expression of MMP-2 and -9, and TIMP-1 and -2 were measured separately using reverse transcription polymerase chain reactions in the mucosal specimens from each 5 segments of the colon. Results: The mRNA expression of MMP-2 and -9, and TIMP-1 in the inflamed tissues of patients with UC was significantly increased compared to non-inflamed tissues of patients with UC and controls (p<0.05). The mRNA expression of MMP-9 and TIMP-1 in non-inflamed tissues of patients with UC was significantly higher than that of controls (p<0.05). In inflamed tissues of UC, the mRNA expression of MMP-2 was significantly correlated with TIMP-2, and the mRNA expression of MMP-9 was significantly correlated with TIMP-1. The MMP-2/TIMP-2 ratio was increased in inflamed tissues compared to non-inflamed tissues of patients with UC and controls (p<0.05). Conclusions: MMP-2 and-9, and TIMP-1 are likely to contribute to the inflammatory cascade in UC. MMP-2 and-9, and TIMP-1 might be important clues to solve the pathogenesis of UC. (Intest Res 2009;7:32-40)
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A Case of Successful Endoscopic Clipping in Iatrogenic Rectal Perforation during Colonoscopy
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Ji Hyun Song, Ki Nam Shim, Seong Eun Kim, Hyun Joo Song, Hee Jung Oh, Kum Hei Ryu, Hye Jung Yeom, Tae Hun Kim, Hye Kyung Jung, Sung Ae Jung, Kwon Yoo, Il Hwan Moon
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Intest Res 2005;3(2):154-155. Published online December 30, 2005
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Abstract
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- Colonoscopy has become the principal method for diagnosis, treatment, and follow-up of colorectal disease. However, colonoscopy is an invasive procedure with an associated risk of complications. Especially, perforation of the colon and rectum during colonoscopy is a rare but serious complication. The choice of conservative versus surgical treatment for this complication remains controversial. In general, conservative treatment is reserved for patient in good general health with good bowel preparation and absence of signs of peritonitis during 24 to 48 hours following the perforation. Conservative management consists of intestinal rest, intravenous fluids and antibiotics, nasogastric tube decompression, and frequent clinical examination. In case of iatrogenic perforation, if the wound is immediately closed with clips, contamination of the peritoneal cavity can be minimized. We report here a patient who sustained iatrogenic rectal perforation caused by diagnostic colonoscopy that was successfully treated by endoscopic clipping therapy. (Intestinal Research 2005;3:154-156)
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