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 ]

The severity of bowel symptoms is evaluated with a quality of life questionnaire, the Francis Score before and after 6 weeks of complementation in placebo and verum groups.


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