Clinical Trial: Irritable Bowel Syndrome and Lactibiane Tolerance
Study Status: Completed
Recruit Status: Unknown status
Study Type: Interventional
Official Title: Effect of Lactibiane Tolerance on Symptoms Severity of Irritable Bowel Syndrome
Brief Summary: The purpose of this study is to evaluate the effects of a probiotic combination (Lactibiane Tolerance) on the severity of symptoms in patients with irritable bowel syndrome (IBS).
Detailed Summary:
The primary purpose of this study is to evaluate the effects of a probiotic combination (Lactibiane Tolerance) on the severity of symptoms in patients with irritable bowel syndrome (IBS).
The secondary purposes are to evaluate the effects of the intervention on:
- quality of life
- severity of fatigue, anxiety and depression
- levels of inflammatory markers in blood and tools
Sponsor: Pileje
Current Primary Outcome: Severity of bowel symptoms according to the Francis Score [ Time Frame: After 6 weeks of complementation ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Quality of life [ Time Frame: after 6 weeks of complementation ]Effect of the intervention on transit and abdominal pain
- Severity of Anxiety/Depression [ Time Frame: after 6 weeks of complementation ]The level of anxiety/depression will be measured with the HAD scale
- Impact of the complementation on fatigue [ Time Frame: after 6 weeks of complementation ]The level of fatigue will be measured with the score to the fatigue Impact Scale (FIS)
- Impact of the intervention on immunological parameters in stools [ Time Frame: after 6 weeks of complementation ]The effects of the intervention on immunological parameters in stools will be evaluated via the levels of beta-defensine 2 and sérine protease activities
- Impact of the intervention on immunological parameters in blood [ Time Frame: after 6 weeks of complementation ]The impact of the intervention on immunological parameters in blood will be measured with levels of endotoxines, ultrasensitive protein C Reactive and cytokines
- Severity of bowel symptoms according to the Francis Score [ Time Frame: after 2 weeks of wash-out ]The severity of bowel symptoms is evaluated with the Francis Score before 6 weeks of complementation and after 2 weeks of wash-out in placebo and verum groups
- Quality of life [ Time Frame: after 2 weeks of wash-out ]Effect of the intervention on transit and abdominal pain
- severity of the anxiety/depression [ Time Frame: after 2 weeks of wash-out ]The level of anxiety/depression will be measured with the HAD scale
- Impact of the complementation on fatigue [ Time Frame: After 2 weeks of wash out ]The level of fatigue will be measured with the score to the fatigue Impact Scale (FIS)
- Impact of the intervention on immunological parameters in stools [ Time Frame: after 2 weeks of wash out ]The effects of the intervention on immunological parameters in stools will be avaluated via the levels of beta-defensine 2 and sérine protease activities
- Impact of the intervention on immunological parameters in blood [ Time Frame: after 2 weeks of wash-out ]The impact of the intervention on immunological parameters in blood will be measured with levels of endotoxines, ultrasensitive protein C Reactive and cytokines
Original Secondary Outcome: Same as current
Information By: Pileje
Dates:
Date Received: October 10, 2011
Date Started: April 2010
Date Completion: December 2012
Last Updated: February 6, 2012
Last Verified: February 2012