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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).
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Probiotics Excipients |
|
| Lactibiane Tolerance | Experimental | Probiotics combination |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lactibiane Tolerance | Dietary Supplement | Probiotics combination 2 gelules per days during 6 weeks |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Piche Thierry, MD | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chu L'Archet 2 | Nice | Alpes Maritimes | 06200 | France |
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| ID | Term |
|---|---|
| D043183 | Irritable Bowel Syndrome |
| ID | Term |
|---|---|
| D003109 | Colonic Diseases, Functional |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
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| ID | Term |
|---|---|
| D019936 | Probiotics |
| ID | Term |
|---|---|
| D019587 | Dietary Supplements |
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
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| Placebo | Dietary Supplement | Placebo 2 gelules per days for 6 weeks |
|
| 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 |
| D004066 | Digestive System Diseases |
| D019602 |
| Food and Beverages |