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The mode of delivery affects the diversity and colonization pattern of the gut microbiota during the first year of infants' life.
Probiotics have been observed to positively influence the host's health, but to date few data about the ability of probiotics to modify the gut microbiota composition exist. 40 newborns born by elective caesarian sectional be randomized to a Lactobacillus kefiri LKF01 DSM32079 (LKEF) supplementation or placebo for 21 days. Changes in the gut microbiota composition were detected by using a Next Generation Sequencing technology.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lactobacillus kefiri LKF01 DSM32079 | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lactobacillus kefiri LKF01 DSM32079 | Dietary Supplement | Lactobacillus kefiri LKF01 DSM32079 in drop formulation. 5 drop/daily for 21 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Presence of Lactobacillus kefiri LKF01 DSM32079 (LKEF) in fecal sample | To evaluate the ability of Lactobacillus kefiri LKF01 DSM32079 (LKEF) to colonize the intestinal environment of newborns born by caesarian section and modify the gut microbiota composition by using a Next Generation Sequencing technology. Presence of Lactobacillus kefiri LKF01 DSM32079 (LKEF) in fecal sample. | 21 days after supplementation start |
| Number of participants with treatment-related adverse event | A structured diary on possible treatment-related adverse event will be given to mothers. | During 21 days after supplementation |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dept Of Obstetrics and Neonatology - Section of Neonatology University of Bari Policlinico Hospital | Bari | 70124 | Italy |
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| ID | Term |
|---|---|
| D003141 | Communicable Diseases |
| ID | Term |
|---|---|
| D007239 | Infections |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Placebo | Dietary Supplement | Placebo in drop formulation. 5 drop/daily for 21 days |
|