Irritable Bowel Syndrome
Conditions
Keywords
Irritable Bowel Syndrome, Probiotics
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 description
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
Interventions
DIETARY_SUPPLEMENTLactibiane Tolerance
Probiotics combination 2 gelules per days during 6 weeks
DIETARY_SUPPLEMENTPlacebo
Placebo 2 gelules per days for 6 weeks
Sponsors
PiLeJe
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Severity of bowel symptoms according to the Francis Score | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Severity of Anxiety/Depression | after 6 weeks of complementation | The level of anxiety/depression will be measured with the HAD scale |
| Impact of the complementation on fatigue | 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 | 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 |
| Quality of life | after 6 weeks of complementation | Effect of the intervention on transit and abdominal pain |
| Severity of bowel symptoms according to the Francis Score | 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 |
| severity of the anxiety/depression | after 2 weeks of wash-out | The level of anxiety/depression will be measured with the HAD scale |
| Impact of the intervention on immunological parameters in blood | 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 |
Countries
France
Outcome results
None listed