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[Saccharomyces cerevisiae] A randomized clinical trial of Saccharomyces cerevisiae versus placebo in the irritable bowel syndrome.

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A randomized clinical trial of Saccharomyces cerevisiae versus placebo
in the irritable bowel syndrome.


Guillaume Pineton de Chambruna,b,c, Christel Neutb,c,d, Amélie Chaub,c,e, Murielle Cazaubielf, Fanny Pelering, Peter Justeng, Pierre Desreumauxa,b,c,∗




  

   Abstract


   Background: We aimed to evaluate clinical symptoms in subjects with irritable bowel syndrome receiving Saccharomyces  

  cerevisiae in a randomized double-blind placebo-controlled clinical trial.


   Methods : Overall, 179 adults with irritable bowel syndrome (Rome III criteria) were randomized to receive once daily 500 mg of       

  Saccharomyces cerevisiae, delivered by one capsule (n = 86, F: 84%, age: 42.5 ± 12.5), or placebo (n = 93, F: 88%, age: 45.4

  ± 14) for 8 weeks followed by a 3-week washout period. After a 2-week run-in period, cardinal symptoms (abdominal pain / 

  discomfort, bloating/distension, bowel movement difficulty) and changes in stool frequency and consistency were recorded daily 

  and assessed each week. A safety assessment was carried out throughout the study.


   Results : The proportion of responders, defined by an improvement of abdominal pain/discomfort, was significantly higher (p =  

  0.04) in the treated group than the placebo group (63% vs 47%, OR = 1.88, 95%, CI: 0.99–3.57) in the last 4 weeks of   

  treatment. A non-significant trend of improvement was observed with Saccharomyces cerevisiae for the other symptoms. 

  Saccharomyces cerevisiae was well tolerated and did not affect stool frequency and consistency.


   Conclusion : Saccharomyces cerevisiae is well tolerated and reduces abdominal pain/discomfort scores
  without stool modification. Thus, Saccharomyces cerevisiae may be a new promising candidate for improving
  abdominal pain in subjects with irritable bowel syndrome.


 

제목 

A randomized clinical trial of Saccharomyces cerevisiae versus placebo in the irritable bowel syndrome


배경

우리는 무작위 이중맹검 위약대조 임상시험에서 Saccharomyces cerevisiae를 투여받는 과민성대장증후군 환자의 임상 증상을 평가하고자 하였다.


방법

전체적으로, 과민성대장증후군(로마기준법III)을 가진 성179명 중 무작위로Saccharomyces cerevisiae 500mg이 들어있는 1캡슐 (n=86, F:84%, 연령:42.5±12.5) 또는 플라시보(n=93, F:88%, 연령:45.4±14)를 매일 하나씩 8주간 섭취하였고 3주간의 유실기간을 가졌다. 2주간동안 섭취 하였을 때부터 추기경증상 (복부통증/불편감, 복부팽창/팽만, 장운동곤란)과 대변 빈도 및 일관성의 변화를 매일 기록하고 매주 평가했다. 안전성 평가는 연구 전반에 걸쳐 수행되었다.


결과

부통증/불편감 개선으로 정의 된 반응군의 비율은 치료군(p=0.04)이 위약군(63% 47%, OR=1.88, 95%, CI:0.99-3.57)보다 유의하게 높았다. 치료 마지막 4주 동안. Saccharomyces cerevisiae의 다른 증상에 대한 개선은 유의하지 않은 경향이 관찰되었다. Saccharomyces cerevisiae는 잘 견디며 대변의 빈도와 일관성에 영향을 미치지 않았다.


결론

Saccharomyces cerevisiae는 내약성이 뛰어나고 변을 수정하지 않고도 복통/불편감을 줄일 수 있다. 따라서 Saccharomyces cerevisiae는 과민성대장증후군 환자에서 복부 통증을 개선시키는 새로운 유망한 후보자 일 수 있다.




[출처 : G. Pineton de Chambrun et al. / Digestive and Liver Disease 47 (2015) 119–124]











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