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Aim of the study. To evaluate if L. reuteri DSM 17938 supplementation since the first days of life can reduce the onset of gaseous colic in neonates and the onset of minor digestive disorders such as regurgitation and constipation.
Study Design. Double blind, randomized, controlled, multicenter study. 492 neonates of 37-42 gestational age, breast or formula fed, will receive L. reuteri 5 drops (1x108 CFU) daily or placebo for 28 days.
After the inclusion, at baseline will be performed :
The patients will receive the probiotics/placebo every days for 28 days and the 29th will be repeated the following analyses:
Primary outcome :
To define if Lactobacillus reuteri supplementation can reduce the onset of gaseous colic, regurgitation and of constipation.
Inclusion criteria
Exclusion criteria
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lactobacillus reuteri | Active Comparator | Dietary Supplement |
|
| Placebo | Placebo Comparator | Dietary Supplement |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lactobacillus reuteri | Dietary Supplement | 1000000000 CFU per day (5 drops) for 28 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Reduction of the onset of gaseous colic, regurgitation and of constipation. | After the inclusion, at baseline will be performed :
The patients will receive the probiotics/placebo every days for 28 days and the 29th will be repeated the following analyses:
| one year |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Flavia Indrio, MD | University of Bari | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Bari | Bari | BA | 70124 | Italy | ||
| Ospedale Sant'Orsola Malpighi |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24424513 | Derived | Indrio F, Di Mauro A, Riezzo G, Civardi E, Intini C, Corvaglia L, Ballardini E, Bisceglia M, Cinquetti M, Brazzoduro E, Del Vecchio A, Tafuri S, Francavilla R. Prophylactic use of a probiotic in the prevention of colic, regurgitation, and functional constipation: a randomized clinical trial. JAMA Pediatr. 2014 Mar;168(3):228-33. doi: 10.1001/jamapediatrics.2013.4367. |
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| ID | Term |
|---|---|
| D005764 | Gastroesophageal Reflux |
| ID | Term |
|---|---|
| D015154 | Esophageal Motility Disorders |
| D003680 | Deglutition Disorders |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
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| Placebo | Dietary Supplement | 5 drops daily for 28 days |
|
| Bologna |
| BO |
| Italy |
| Arcispedale S. Anna | Ferrara | FE | Italy |
| Ospedale Civile | Crotone | KR | Italy |
| Ospedale di Sesto S. Giovanni | Milan | MI | Italy |
| Ospedale "SS. Annunziata" | Taranto | TA | Italy |
| Ospedale "Frà Castoro" | San Bonifacio | VR | Italy |
| Policlinico "S. Matteo" | Pavia | Italy |
| D004066 | Digestive System Diseases |