Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Assessment of the digestive tolerability of the PROMITOR® .
The trial will be multicenter, double-blind, placebo-controlled, randomized with a 4-arm parallel-design. The subjects wil be randomized to one of the four arms, i.e. four doses of investigational product balanced in maltodextrin, given at the doses of 6, 9 or 12 g (corresponding to 4, 6, or 8 g of fibers) twice a day with the meals of the morning and of the evening versus control (maltodextrin, no fibers) over one week of intake.
The total sample size is 40 healthy children from 8 to 12 years old, male and female.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Placebo |
|
| PROMITOR® dose 1 | Active Comparator | Investigational product dose 1 |
|
| PROMITOR® dose 2 | Active Comparator | Investigational product dose 2 |
|
| PROMITOR® dose 3 | Active Comparator | Investigational product dose 3 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo (including Maltodextrin) | Drug |
| ||
| PROMITOR® (including Maltodextrin) |
| Measure | Description | Time Frame |
|---|---|---|
| Assessment of the digestive tolerability of the Investigational Product (abdominal pain) | Using analog visual scale | 7 days of intake |
| Assessment of the digestive tolerability of the Investigational Product (rumbling) | Using analog visual scale | 7 days of intake |
| Assessment of the digestive tolerability of the Investigational Product (bloating) | Using analog visual scale | 7 days of intake |
| Assessment of the digestive tolerability of the Investigational Product (flatulence) | Using analog visual scale | 7 days of intake |
| Assessment of the digestive tolerability of the Investigational Product (stools consistency & frequency) | Using analog visual scale | 7 days of intake |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Biofortis | Saint-Herblain | 44800 | France | |||
| Metabolic Unit, Clinical Development Unit Nestec |
Not provided
| ID | Term |
|---|---|
| D012817 | Signs and Symptoms, Digestive |
| ID | Term |
|---|---|
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Drug |
Investigational product dose 1 |
|
| PROMITOR® (including Maltodextrin) | Drug | Investigational product dose 2 |
|
| PROMITOR® (including Maltodextrin) | Drug | Investigational product dose 3 |
|
| Lausanne |
| 1000 |
| Switzerland |