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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 | Placebo |
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| 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 | Change in mean crying and fussing time as assessed by the Baby's Day Diary | From baseline to Day 7 |
| Measure | Description | Time Frame |
|---|---|---|
| Crying and fussing time | Change in mean crying and fussing time as assessed by the Baby's Day Diary | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sanna Nyström, PhD | Contact | +46761483866 | sny@biogaia.se | |
| Petra J Lierud | Contact | +46724504400 | pjl@biogaia.se |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UMHAT Deva Maria | Recruiting | Burgas | 8127 | Bulgaria |
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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 |
|
| From baseline up to Day 21 |
| Family Quality of Life | Change in family QoL measured by the PedsQL Family Impact Module (Acute) - Total Score | From baseline up to Day 21 |
| Sleeping time | Change in mean sleeping time as assessed by Baby´s Day Diary | From baseline up to Day 21 |
| Maternal depression | Change in maternal depression as assessed by the Edinburgh Postnatal Depression Scale Total Score | From baseline up to Day 21 |
| Medical Centre Asklepiy OOD | Recruiting | Dupnitsa | 2600 | Bulgaria |
|
| AIPSMP | Recruiting | Stara Zagora | 6000 | Bulgaria |
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| Ipsmp Eood | Recruiting | Stara Zagora | 6000 | Bulgaria |
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