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It is believed that probiotic Lactobacillus reuteri will improve the symptoms of breast-fed infants with colic.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lactobacillus reuteri | Dietary Supplement | 5 drops of study product 30 minutes before feeding. |
| Measure | Description | Time Frame |
|---|---|---|
| * Reduction of daily average crying time to less than 3 hours from baseline to the end of the study period as measured using a daily reporting of crying time by the parents. | 7, 14 and 21 days |
| Measure | Description | Time Frame |
|---|---|---|
| Number of responders versus non-responders with L. reuteri versus placebo at end of the study. | 21 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Misty R Ross, MA | Contact | 479-254-6772 | 21 | mross@chirpresearch.com |
| Name | Affiliation | Role |
|---|---|---|
| Bryan M Harvey, M.D. | Children's Investigational Research Program | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's Investigational Research Program | Recruiting | Bentonville | Arkansas | 72712 | United States |
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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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