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Bifidobacterium strains with potential health benefits can contribute to the gastrointestinal wellbeing. However, the ability of these strains to survive gastro-intestinal tract stress and their impact on gut microbiome remains to be clarified. This is why the current study aims to assess the impact of Bifidobacteria consumption on human gut microbiome compared to control product.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Oral administration of experimental product A | Experimental | Test product A: fermented dairy product containing Bifidobacterium strains |
|
| Oral administration of Control product | Placebo Comparator | Control product: commercially available yoghurt without Bifidobacterium strains |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 28-days consumption of Product A in 45 to 60-year-old healthy subjects | Other | 40 healthy volunteers will consume Product A twice per day during 28 consecutive days |
|
| Measure | Description | Time Frame |
|---|---|---|
| The primary outcome parameter in this study is the change from baseline after 28-days product consumption of the number of distinct Bifidobacterium species. | After 28 days of study product consumption |
| Measure | Description | Time Frame |
|---|---|---|
| The proportion of subjects with presence of viable bacteria of the provided Bifidobacterium strains after 28-days product consumption. | After 28 days of study product consumption | |
| The changes from baseline after 28-days product consumption in quantification of viable bacteria of the provided Bifidobacterium strains. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Danone Global Research & Innovation Center | Contact | +33 (0)1 69 35 70 00 | register.clinicalresearchnutricia@danone.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CEN | Dijon | France |
|
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| ID | Term |
|---|---|
| D035061 | Control Groups |
| ID | Term |
|---|---|
| D015340 | Epidemiologic Research Design |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D012107 | Research Design |
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| 28-days consumption of Control product in 45 to 60-year-old healthy subjects | Other | 40 healthy volunteers will consume Control product twice per day during 28 consecutive days |
|
| After 28 days of study product consumption |
| The change from baseline after 28-days product consumption of Bifidobacterium diversity indices. | After 28 days of study product consumption |
| D008722 | Methods |