Effect of a Mixture of New Probiotic Strains in Preterm Infants
NCT ID: NCT03701906
Last Updated: 2020-10-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
30 participants
INTERVENTIONAL
2018-10-22
2019-12-31
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
TRIPLE
Study Groups
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Lactobacillus PS11603 & Bifidobacterium PS10402
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.
Lactobacillus PS11603 & Bifidobacterium PS10402
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.
Placebo
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.
Placebo
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.
Interventions
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Lactobacillus PS11603 & Bifidobacterium PS10402
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.
Placebo
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Written informed consent signed by the parent or legal guardian.
* Tolerate enteral feeding, at least 10mL / kg / day.
* Postnatal age ≤ 5 days
Exclusion Criteria
* With short bowel syndrome or any surgery in the gastrointestinal tract
* With defect in the intestinal epithelial barrier
1 Minute
5 Days
ALL
Yes
Sponsors
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ProbiSearch SL
INDUSTRY
Responsible Party
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Principal Investigators
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Susana Manzano, PhD
Role: STUDY_CHAIR
ProbiSearch SL
Locations
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Hospital Universitario La Paz
Madrid, , Spain
Countries
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References
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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.
Other Identifiers
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PRE/18.02
Identifier Type: -
Identifier Source: org_study_id
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