초록 ▼

Ⅲ. 연구개발의 내용 및 범위
본 연구에서는 기 연구에서 성과로 과민성 장증상의 개선효과를 보인 균주의 메커니즘을 우선적으로 분석하고 임상평가에 적용하여 효능을 확인하고 산업화하는 것을 목표로 하였다. 이를 위하여 제1세부에서는 추가적인 신규 항염증활성 우수 균주를 탐색하여 그 특성을 규명하고 제1협동에서는 동물실험을 통하여 선발균주의 항염증, 염증성 장증상 개선효과의 메커니즘을 규명하고 제2협동에서는 이중맹검 인체실험을 통하여 개발 생균제의 장 증상 저감화 효과와 장내에서의 균총의 변화 메타게놈분석을 통하여 프로바이오틱스의

Ⅲ. 연구개발의 내용 및 범위
본 연구에서는 기 연구에서 성과로 과민성 장증상의 개선효과를 보인 균주의 메커니즘을 우선적으로 분석하고 임상평가에 적용하여 효능을 확인하고 산업화하는 것을 목표로 하였다. 이를 위하여 제1세부에서는 추가적인 신규 항염증활성 우수 균주를 탐색하여 그 특성을 규명하고 제1협동에서는 동물실험을 통하여 선발균주의 항염증, 염증성 장증상 개선효과의 메커니즘을 규명하고 제2협동에서는 이중맹검 인체실험을 통하여 개발 생균제의 장 증상 저감화 효과와 장내에서의 균총의 변화 메타게놈분석을 통하여 프로바이오틱스의 효과를 평가하고자 하였으며 제3협동에서는 개발된 균주의 산업화, 제품화를 위하여 고농도 배양에 의한 고단위 제품을 경제적으로 생산하는 기술개발을 하고자 하였다.

Abstract ▼

Recently, incidence of symptoms of IBS are increasing in Korea according to the westernized food intake and probiotics are regarded as good treatment option for irritable bowel syndrome (IBS) patients. The purpose of this study was to develop
probiotic product with good evidence for the alleviati

Recently, incidence of symptoms of IBS are increasing in Korea according to the westernized food intake and probiotics are regarded as good treatment option for irritable bowel syndrome (IBS) patients. The purpose of this study was to develop
probiotic product with good evidence for the alleviation of symptoms of IBS by evaluating the effectiveness of probiotics through animal and human trial.
Firstly, several human originated probiotics strains have been selected based on the cell culture experiment and the culture conditions were optimized for the nutrient and feeding method. And process and stabilizing material have been developed to improve the stability of the probiotic strains. Identification of the selected strains have been performed at the molecular level.
When the probiotics were tested by animal model, some strains showed good activity for decreasing disease activity index and pro-inflammatory cytokines such as IL-1β, TNF-α and increased occudin which is the tight junction protein.
A total of 31 patients in the placebo group and 32 patients in the probiotics group completed the study. In the placebo group, mean reduction of IBS-SSS after 8 weeks treatment was 69.35 (95% CI : 47.33 to 89.62), and mean reduction of IBS-SSS was 87.19 (95% CI : 62.16 to 113.63) in the probiotics group. In the placebo group, mean reduction of IBS-QoL was 11.48 (95% C.I : 47.33 to 89.62), and mean reduction of IBS-QoL was 14.5 (95% C.I : 9.39 to 20.27). However, there was no statistically significant difference of IBS-SSS reduction and IBS-QoL changes after treatment between two groups. On the other hand, there was significant improvement of abdominal symptom severity in the probiotics group. There was no negative side effect from probiotics. However, there was significant abdominal symptom severity improvement in the probiotics treatment group.
The process scale up has been performed up to 5KL fermentor for the production of selected probiotics and the process for harvesting and the stabilizing have been applied to the production scale. And finally, the product containing the selected
probiotics have been produced and commercialized.