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| ID | Type | Description | Link |
|---|---|---|---|
| CSUB0031 | Other Grant/Funding Number | Biogaia AB |
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| Name | Class |
|---|---|
| BioGaia AB | INDUSTRY |
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Lactobacilli are commensal bacteria common to the gut of all mammals studied and traditionally associated with foods are considered safe.The established safe use on a diversity of foods and supplement products worldwide supports this conclusion. Lactobacillus reuteri is one species of Lactobacillus that naturally inhabits the gastrointestinal tract of humans and is one of the few autochthonous (indigenous) Lactobacillus species in infants as well as adults.
Although the tolerability of DSM 17938 in a tablet formulation has earlier been established, it is desirable to repeat the assessment in this novel formulation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Double dose | Active Comparator | One stick pack with active ingredients contains 1.0 g contains 75% GOS (galactooligosaccharide), 25% L-Rhamnose, 1x108 live bacteria (CFU) Lactobacillus reuteri and silicon dioxide |
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| Single dose | Active Comparator | One stick pack with active ingredients contains 1.0 g contains 75% GOS (galactooligosaccharide), 25% L-Rhamnose, 1x108 live bacteria (CFU) Lactobacillus reuteri and silicon dioxide |
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| Placebo | Placebo Comparator | One stick pack with placebo contains 1.0 g maltodextrin and silicon dioxide |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lactobacillus Reuteri DSM 17938 | Dietary Supplement | One stick pack in the morning and one stick pack afternoon/evening for 28 days. |
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| Measure | Description | Time Frame |
|---|---|---|
| Safety measured by blood chemistry parameters | To assess the safety of a novel formulation containing Lactobacillus reuteri DSM 17938 by measuring blood chemistry parameters before and after 28 days of supplementation. | 28 days |
| Tolerability measured by blood chemistry parameters | To assess tolerability of a novel formulation containing Lactobacillus reuteri DSM 17938 by measuring blood chemistry parameters before and after 28 days of supplementation. | 28 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Johan Olsson, PhD | KPL Good Food Practice AB | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Good Food Practice Uppsala | Uppsala | 751 83 | Sweden |
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