Not provided
Not provided
Not provided
Not provided
Poor recruitment
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Pontificia Universidad Catolica de Chile | OTHER |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This application a phase II clinical trial to address the possible active mechanisms of probiotics and to obtain preliminary efficacy and safety data after the administration of a probiotic, Lactobacillus reuteri a population of premature infants.
The hypothesis is that the exogenous supplementation Lactobacillus reuteri to premature infants will lead to clinical beneficial effects by modifying their intestinal microbiota and enhancing their intestinal immunological response.
The primary outcome "days to achieve full feeds" will be measure during the the first month of life Secondary outcomes will be measured at baseline (before intervention), 3 weeks after intervention, once intervention discontinued and at 6 months of live
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| probiotic group | Experimental | Lactobacillus reuteri will be given at a dose of 1x108 colony forming units (CFU)/day |
|
| Placebo | Placebo Comparator | The placebo consists of an identical formulation except that the L. reuteri is not present. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lactobacillus reuteri | Dietary Supplement | Lactobacillus reuteri DSM will be given at a dose of 1x108 colony forming units (CFU)/day |
|
| Measure | Description | Time Frame |
|---|---|---|
| Time to reach full feeds | Days to reach full feeds from the day feeds are started | First 40 days after birth |
| Measure | Description | Time Frame |
|---|---|---|
| Intestinal colonization | PCR quantification of lactobacillus reuteri in the stools | 0-6 months after birth |
| Intestinal immunological response | Quantification immunological markers in the stools |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Teresa del Moral, MD, MPH | University of Miami | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Sotero del Rio | Santiago | Chile | ||||
| Pontifica Universidad Catolica |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37493095 | Derived | Sharif S, Meader N, Oddie SJ, Rojas-Reyes MX, McGuire W. Probiotics to prevent necrotising enterocolitis in very preterm or very low birth weight infants. Cochrane Database Syst Rev. 2023 Jul 26;7(7):CD005496. doi: 10.1002/14651858.CD005496.pub6. | |
| 33058137 | Derived | Sharif S, Meader N, Oddie SJ, Rojas-Reyes MX, McGuire W. Probiotics to prevent necrotising enterocolitis in very preterm or very low birth weight infants. Cochrane Database Syst Rev. 2020 Oct 15;10(10):CD005496. doi: 10.1002/14651858.CD005496.pub5. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D047928 | Premature Birth |
| ID | Term |
|---|---|
| D007752 | Obstetric Labor, Premature |
| D007744 | Obstetric Labor Complications |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
Not provided
Not provided
Administration of probiotic Lactobacillus Reuteri
Not provided
Not provided
Administration of placebo
| Placebo | Other | The placebo consists of an identical formulation except that the L. reuteri is not present. |
|
| 0-6 months |
| Santiago |
| Chile |
| D000091642 | Urogenital Diseases |