Chu L'Archet 2
Nice, Alpes Maritimes, 06200, France
Completed
NCT Number: NCT01529359
Irritable Bowel Syndrome and Lactibiane Tolerance
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).
Completed
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Conditions
Age range
18 year–70 year
Sex eligibility
All sexes
Study type
Interventional
Phase
Not applicable
Primary location
About this study
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
Who can participate
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
Lactibiane Tolerance
Dietary SupplementProbiotics combination 2 gelules per days during 6 weeks
Other names: Probiotic
Placebo
Dietary SupplementPlacebo 2 gelules per days for 6 weeks
Primary outcomes
-
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.
Secondary outcomes
-
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
Sponsors and collaborators
Lead sponsor
PiLeJe
Industry
Registry information
Official study title
Effect of Lactibiane Tolerance on Symptoms Severity of Irritable Bowel Syndrome
Important dates
- Study start
- 2010
- Primary completion
- 2013
- Study completion
- 2013
- First posted
- Feb 8, 2012
- Registry last updated
- Apr 20, 2021
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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