Irritable Bowel Syndrome and Lactibiane Tolerance

Study Overview
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Brief Summary
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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 Description
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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

Official Title
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Effect of Lactibiane Tolerance on Symptoms Severity of Irritable Bowel Syndrome

Conditions
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Irritable Bowel Syndrome

Intervention / Treatment
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* Dietary Supplement: Lactibiane Tolerance
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Irritable bowel syndrome according to the Rome II criteria 150< Francis Score < 300 HAD score inferior or egal to 25 Exclusion Criteria: History of hypersensitivity to one of the composant of the product Use of probiotics or antibiotics last four weeks use of prohibited drugs bowel preparation for morphological examination last month pregnancy or lactation immundepressed or co-existing other serious illness or evolutive

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>Probiotics Excipients | Dietary Supplement: Placebo<br>* Placebo 2 gelules per days for 6 weeks<br>|
| Experimental: Lactibiane Tolerance<br>Probiotics combination | Dietary Supplement: Lactibiane Tolerance<br>* Probiotics combination 2 gelules per days during 6 weeks<br>* Other names: Probiotic;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Severity of bowel symptoms according to the Francis Score | 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. | After 6 weeks of complementation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of life | Effect of the intervention on transit and abdominal pain | after 6 weeks of complementation | 
| Severity of Anxiety/Depression | The level of anxiety/depression will be measured with the HAD scale | after 6 weeks of complementation | 
| Impact of the complementation on fatigue | The level of fatigue will be measured with the score to the fatigue Impact Scale (FIS) | after 6 weeks of complementation | 
| Impact of the intervention on immunological parameters in stools | The effects of the intervention on immunological parameters in stools will be evaluated via the levels of beta-defensine 2 and sérine protease activities | after 6 weeks of complementation | 
| Impact of the intervention on immunological parameters in blood | The impact of the intervention on immunological parameters in blood will be measured with levels of endotoxines, ultrasensitive protein C Reactive and cytokines | after 6 weeks of complementation | 
| Severity of bowel symptoms according to the Francis Score | 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 | after 2 weeks of wash-out | 
| Quality of life | Effect of the intervention on transit and abdominal pain | after 2 weeks of wash-out | 
| severity of the anxiety/depression | The level of anxiety/depression will be measured with the HAD scale | after 2 weeks of wash-out | 
| Impact of the complementation on fatigue | The level of fatigue will be measured with the score to the fatigue Impact Scale (FIS) | After 2 weeks of wash out | 
| Impact of the intervention on immunological parameters in stools | The effects of the intervention on immunological parameters in stools will be avaluated via the levels of beta-defensine 2 and sérine protease activities | after 2 weeks of wash out | 
| Impact of the intervention on immunological parameters in blood | The impact of the intervention on immunological parameters in blood will be measured with levels of endotoxines, ultrasensitive protein C Reactive and cytokines | after 2 weeks of wash-out | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Irritable Bowel Syndrome, Probiotics