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This randomized, open label, dose-response study will be realized at the first line with Bactecal® D Liquid. The objective is to investigate Bactecal® D Liquid in the context of infantile colics.
The patients will be randomized into two arms, A and B, in function of the intervention dose. The quality of life of te parents as well as the daily median crying time and the number of daily crying will be assessed.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Open label Bactecal® D Liquid 1 dose | Experimental | Patients will receive 1 dose of Bactecal® D Liquid by day which corresponds to 2 ml of product |
|
| Open label Bactecal® D Liquid 2 doses | Experimental | Patients will receive 2 doses of Bactecal® D Liquid by day which correspond to 4 ml of product. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bactecal® D Liquid | Dietary Supplement | The patients will be randomized into two arms, A and B, in function of the intervention dose |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in parent quality of life (QoL) score | By measuring parent quality of Life (QoL) score. Scale from 1 (minimum) to 7 (maximum). Higher scores mean a better outcome. | Change from baseline parent QoL score at 28 days |
| Measure | Description | Time Frame |
|---|---|---|
| Change of daily median crying time | By measuring the mean change in crying time | Change from baseline daily median crying time at 28 days |
| Change of the number of crying | By measuring the numbers per day |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UZ Brussel | Brussels | Belgium |
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| ID | Term |
|---|---|
| D003085 | Colic |
| ID | Term |
|---|---|
| D007232 | Infant, Newborn, Diseases |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
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| Change from baseline number of crying at 28 days |