Effect of Probiotics on Infant's Fecal Microbiota Composition
NCT ID: NCT05524649
Last Updated: 2025-02-11
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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RECRUITING
NA
120 participants
INTERVENTIONAL
2022-06-01
2025-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
QUADRUPLE
Study Groups
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Experimental 1
Probiotic single strain formulation comprising Bifidobacterium longum CECT7894 in liquid format suspended in sunflower oil. This probiotic strain has Qualified Presumption of Safety (QPS) status by European Food Safety Authority.
Food Supplement 1
Probiotic single strain formulation containing Bifidobacterium longum CECT7894 for 3 months 5 drops/day
Experimental 2
Probiotic single strain formulation comprising Pediococcus pentosaceus CECT8330 in liquid format suspended in sunflower oil. This probiotic strain has Qualified Presumption of Safety (QPS) status by European Food Safety Authority.
Food Supplement 2
Probiotic single strain formulation containing Pediococcus pentosaceus CECT8330 for 3 months 5 drops/day
Placebo
Sunflower oil
Placebo
5 drops/day for 3 months of sunflower oil
Interventions
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Food Supplement 1
Probiotic single strain formulation containing Bifidobacterium longum CECT7894 for 3 months 5 drops/day
Food Supplement 2
Probiotic single strain formulation containing Pediococcus pentosaceus CECT8330 for 3 months 5 drops/day
Placebo
5 drops/day for 3 months of sunflower oil
Eligibility Criteria
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Inclusion Criteria
* Age between 1 and 90 days
* Gestational age between 37 and 42 weeks
* Appropiate birth weight for gestational age (between P10 and P90)
* APGAR test score for birth normal at 1' and 5' of 7-10
* Whose parents accept the follow-up of the study procedures and sign the informed consent
Exclusion Criteria
* Fed with infant formula containing probiotics or other aliments or food supplement based in probiotics 4 weeks prior the start of the study
* Infants who have taken antibiotics 4 weeks prior the start study
* Infants with cow's milk protein allergy, lactose intolerance or other digestive diseases
* Mother's pathological background and during gestation: neurologic disorders, matabolopaties, diabetes mellitus type 1, chronic disease (hypothyroidism), maternal malnutrition
* Acute congenital or acquired diseases which can interfere with the growth and the normal feeding of the infant
* TORCH complex infections
* Every other diseases related with the immune system
* Parents who can not accomplish the follow-up of the study (medical criterium)
1 Day
90 Days
ALL
Yes
Sponsors
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Ministry of Science and Innovation, Spain
OTHER_GOV
AB Biotics, SA
INDUSTRY
Responsible Party
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Locations
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Instituto Nacional de Pediatría Insurgentes Sur 3700-C, Insurgentes Cuicuilco
Alcaldía Coyoacán, Puebla, Mexico
Clínica Viamed Montecanal
Zaragoza, Aragon, Spain
Countries
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Central Contacts
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Facility Contacts
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References
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Chen K, Liu C, Li H, Lei Y, Zeng C, Xu S, Li J, Savino F. Infantile Colic Treated With Bifidobacterium longum CECT7894 and Pediococcus pentosaceus CECT8330: A Randomized, Double-Blind, Placebo-Controlled Trial. Front Pediatr. 2021 Sep 10;9:635176. doi: 10.3389/fped.2021.635176. eCollection 2021.
Braegger C, Chmielewska A, Decsi T, Kolacek S, Mihatsch W, Moreno L, Piescik M, Puntis J, Shamir R, Szajewska H, Turck D, van Goudoever J; ESPGHAN Committee on Nutrition. Supplementation of infant formula with probiotics and/or prebiotics: a systematic review and comment by the ESPGHAN committee on nutrition. J Pediatr Gastroenterol Nutr. 2011 Feb;52(2):238-50. doi: 10.1097/MPG.0b013e3181fb9e80.
Castanet M, Costalos C, Haiden N, Hascoet JM, Berger B, Sprenger N, Grathwohl D, Brussow H, De Groot N, Steenhout P, Pecquet S, Benyacoub J, Picaud JC. Early Effect of Supplemented Infant Formulae on Intestinal Biomarkers and Microbiota: A Randomized Clinical Trial. Nutrients. 2020 May 20;12(5):1481. doi: 10.3390/nu12051481.
Hoy-Schulz YE, Jannat K, Roberts T, Zaidi SH, Unicomb L, Luby S, Parsonnet J. Safety and acceptability of Lactobacillus reuteri DSM 17938 and Bifidobacterium longum subspecies infantis 35624 in Bangladeshi infants: a phase I randomized clinical trial. BMC Complement Altern Med. 2016 Feb 2;16:44. doi: 10.1186/s12906-016-1016-1.
Navarro-Tapia E, Sebastiani G, Sailer S, Toledano LA, Serra-Delgado M, Garcia-Algar O, Andreu-Fernandez V. Probiotic Supplementation During the Perinatal and Infant Period: Effects on Gut Dysbiosis and Disease. Nutrients. 2020 Jul 27;12(8):2243. doi: 10.3390/nu12082243.
Radke M, Picaud JC, Loui A, Cambonie G, Faas D, Lafeber HN, de Groot N, Pecquet SS, Steenhout PG, Hascoet JM. Starter formula enriched in prebiotics and probiotics ensures normal growth of infants and promotes gut health: a randomized clinical trial. Pediatr Res. 2017 Apr;81(4):622-631. doi: 10.1038/pr.2016.270. Epub 2016 Dec 21.
Other Identifiers
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AB-BABYCARE-21
Identifier Type: -
Identifier Source: org_study_id
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