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| ID | Type | Description | Link |
|---|---|---|---|
| 2016-A00597-44 | Other Identifier | 2016-A00597-44 |
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| Name | Class |
|---|---|
| 3i nature | OTHER |
| European Regional Development Fund | OTHER |
| Université d'Auvergne | OTHER |
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The aim of this study is to assess the behavior of a model probiotic strain, Lactobacillus salivarius, in the digestive tract of healthy volunteers and of ileostomized patients, depending on its galenic form.
Two classic forms will be tested (powder and pill). An innovative galenic form (pill with retarded release), developed to enhance intestinal viability and probiotic efficacy, will also be tested.
Probiotic survival in the stomach and in stools will be assessed on 9 healthy volunteers. It will be evaluated in the stomach after one unique probiotic intake. Gastric content will be collected at different times, up until an hour after probiotic ingestion.
Fecal probiotic survival will be evaluated after a 7-day period of probiotic intake. Initial stool collection, before first probiotic intake, will be used as control. Stools will be collected after 7 days of treatment (D8) and 3 days after last intake (D10).
Probiotic survival in the small intestine will be assessed on 9 patients with stable medical condition that either have a terminal or preterminal ileostomy. It will be evaluated after one unique probiotic intake. Ileal content will then be collected within 4 hours after intake.
Probiotic survival will be evaluated in the stomach, small intestine and in stools by qPCR and determination of CFU. Microbiota composition will be determined by pyrosequencing on ileal and fecal samplings. Finally, metabolic activity will be determined by chromatography with a short chain fatty acid dosage.
Healthy volunteers will test each of the 3 galenic forms of Lactobacillus salivarius on 3 periods of 7 days. Each period will be separated from another with a 14-day wash-out period at least.
Ileostomized patients will only take a unique dose of each probiotic. Each intake of a different probiotic will be separated from another by a 14-day wash-out period at least.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Healthy volunteers | Active Comparator | Healthy volunteers will test each of the 3 galenic forms of Lactobacillus salivarius on 3 periods of 7 days. Each period will be separated from another with a 14-day wash-out period at least. |
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| Ileostomized patients | Active Comparator | Ileostomized patients will only take a unique dose of each probiotic. Each intake of a different probiotic will be separated from another by a 14-day wash-out period at least. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lactobacillus salivarius BL 3123 | Drug | Two classic forms will be tested (powder and pill). An innovative galenic form (pill with retarded release), developed to enhance intestinal viability and probiotic efficacy, will also be tested. |
| Measure | Description | Time Frame |
|---|---|---|
| Survival rate of Lactobacillus salivarius | Measured by qPCR and determination of CFU in gastric content and in stools for each galenic form. | 7 days |
| Measure | Description | Time Frame |
|---|---|---|
| Probiotic residual amount in control healthy volunteer | Measured by qPCR and determination of CFU | 10 days |
| Probiotic residual amount in ostomy pouch | Measured by qPCR and determination of CFU. Fecal microbiota composition at D0 and D8 after the first intake, in the healthy volunteer group, for each 3 galenic forms. |
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Inclusion Criteria:
For the healthy volunteer group :
For the patients with a ostomy pouch :
Exclusion Criteria for both groups :
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Patrick LACARIN | Contact | 04 73 75 11 95 | placarin@chu-clermontferrand.fr | |
| Corinne BOUTELOUP, MD | Contact | cbouteloup@chu-clermontferrand.fr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU Clermont-Ferrand | Recruiting | Clermont-Ferrand | Auvergne | 63003 | France |
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Open
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| 8 days |
| Ileal microbiota composition | Patients with ostomy pouch | 8 days |
| Potential occurrence of digestive symptoms or extra-digestive | Nausea, bloating, flatulence, abdominal pain, intestinal transit modification | 8 days |
| Comparison of residual probiotic amount between in vivo and in vitro collection in the stomach, ileon and in stools | Measured by qPRC and determination of CFU number | 8 days |