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An interventional, randomized, double-blind, placebo-controlled study will be conducted to investigate the effect of a new probiotic strain Lactobacillus PS11603 & Bifidobacterium PS10402 in premature infants from 28 weeks + 0 days to 30 weeks + 6 days of gestation.
The study duration will be 2 months, which includes 8 weeks product administration. Participants will be randomized assigned to one of the two study groups: the control group with placebo consumption and a probiotic consumption group.
An interventional, randomized, double-blind, placebo-controlled study will be conducted to investigate the effect of a new probiotic strains Lactobacillus PS11603 & Bifidobacterium PS10402 in 30 premature infants born within 28 weeks + 0 days to 30 weeks + 6 days of gestation.
The duration of participation in the study is estimated to be 40-60 days. Participants will be randomized assigned to one of the two arms of the study: the control group, with placebo consumption, and a probiotic consumption group. The aim of the study will be investigate the effect of the probiotics strains in the colonization of the intestinal tract of preterm babies.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lactobacillus PS11603 & Bifidobacterium PS10402 | Active Comparator | A mixture of 1*10E9 colony forming unit (CFU) of Lactobacillus PS11603 and 1*10E8 CFU of Bifidobacterium PS10402 in 1 vial will be dissolved and enterally administered daily until discharge from the Neonatal Unit or until the 36th post-gestational week of age. |
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| Placebo | Active Comparator | 1 vial of Placebo will be dissolved and enterally administered daily until discharge from the Neonatal Unit or until the 36th post-gestational week of age. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lactobacillus PS11603 & Bifidobacterium PS10402 | Dietary Supplement | Approximately 8 weeks intervention study: Participants with 0-5 days of age will start a period of 8 weeks of intervention. During this time the participants will intake one daily dose of the product that contains 1*10E9 CFU of L.salivarius PS11603 and 1*10E8 CFU of B.longum PS10402. |
| Measure | Description | Time Frame |
|---|---|---|
| Counts (CFU/g) of Bifidobacterium and Lactobacillus colonies from fecal samples. | Counts (CFU/g) of Bifidobacterium and Lactobacillus presents in fecal samples from preterm infants | 2 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Susana Manzano, PhD | ProbiSearch SL | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Universitario La Paz | Madrid | 28046 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35221319 | Derived | Moreno-Sanz B, Montes MT, Manzano S, Espinosa-Martos I, Cardenas N, Esteban S, Cruz M, Jimenez E, de Pipaon MS. Randomized, Double-Blind, Placebo-Controlled Study to Assess the Effect of Two Probiotics on the Preterms' Gut Microbiota. J Pediatr Gastroenterol Nutr. 2022 Jun 1;74(6):e153-e159. doi: 10.1097/MPG.0000000000003427. Epub 2022 Feb 25. |
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| 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 |
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This is an interventional, randomized, double-blind, placebo-controlled, parallel-group study.
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| Placebo | Dietary Supplement | 8 weeks intervention study: A 8 weeks intervention period. During the 8 weeks of intervention the participants will intake one daily dose of placebo supplement. |
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| D000091642 | Urogenital Diseases |