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This is a double-blind, randomized, placebo-controlled, parallel-group study in infants with colic with the primary objective to evaluate crying and fussing time.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| L. reuteri | Experimental | Dietary Supplement: L. reuteri |
|
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| L. reuteri | Dietary Supplement | Supplementation with drops containing L. reuteri once daily for 21 consecutive days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Crying and fussing time | To evaluate crying and fussing time after 7 days of supplementation with L. reuteri in infants with colic. | [Time Frame: From baseline to Day 7] |
| Measure | Description | Time Frame |
|---|---|---|
| Crying and fussing time | Change in mean daily crying and fussing time measured by Baby´s Day Diary | [Time Frame: From baseline up to Day 21] |
| Crying time | Change in mean daily crying time measured by Baby´s Day Diary |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Salento, University Hospital Vito Fazzi Lecce | Lecce | LE | 73100 | Italy |
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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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| Placebo | Dietary Supplement | Supplementation with identical drops without L. reuteri once daily for 21 consecutive days |
|
| [Time Frame: From baseline up to Day 21] |
| Number of responders | Proportion of responders defined as reduction of daily average crying time with 50 % compared to baseline | [Time Frame: From baseline up to Day 21] |
| Family quality of life (family QoL) | Change in family QoL measured by the PedsQL Family Impact Module (Acute) - Total Score | [Time Frame: From baseline up to Day 21] |
| Sleeping time | Change in mean sleeping time measured by Baby´s Day Diary | [Time Frame: From baseline up to Day 21] |
| Maternal depression | Change in maternal depression measured by the Edinburgh Postnatal Depression Scale Total Score | [Time Frame: From baseline up to Day 21] |