Effect of Probiotics on Infant's Fecal Microbiota Composition

Официальное название

Safety, Tolerability and Effect on Fecal Microbiota Composition of Two Probiotic Strains in Infants

Обзор

Randomized clinical trial to evaluate the effect of two probiotic strains which belong to Bifidobacterium Longum and Pediococcus pentosaceus species on fecal microbiota composition in healthy infants. Secondary outcomes comprise evaluation of anthropometric growth, digestive tolerance, sleeping habits, incidence of functional gastrointestinal disorders, incidence of gastrointestinal and respiratory infections, allergic reactions and safety and tolerability of the product.

Подробное описание

Double-blind, randomized, placebo-controlled clinical trial to determine the effect of the probiotic strains Bifidobacterium longum and Pediococcus pentosaceus on fecal microbiota composition in infants. Healthy babies with ages comprised between 60 and 90 days who meet inclusion and exclusion criteria will be randomized 1:1:1 to one of the following study groups: one group will receive Bifidobacterium longum, another group will receive Pediococcus pentosaceus and the other one will receive placebo for 3 months. Other study outcomes comprise anthropometric growth, frequency and consistency of the stools, digestive tolerance, wellbeing, number, type and duration of infections and functional gastrointestinal disorders, and adverse events.

Вмешательства

• Пищевая добавка Food Supplement 1
  Probiotic single strain formulation containing Bifidobacterium longum CECT7894 for 3 months 5 drops/day
• Пищевая добавка Food Supplement 2
  Probiotic single strain formulation containing Pediococcus pentosaceus CECT8330 for 3 months 5 drops/day
• Пищевая добавка Placebo
  5 drops/day for 3 months of sunflower oil

Первичные конечные точки

• Change of Bifidobacterium longum and Pediococcus pentosaceus in feces [Срок оценки: day 0, month 3]

Вторичные конечные точки (12)

• Weight change [Срок оценки: day 0, month 1, month 2, month 3]
• Length change [Срок оценки: day 0, month 1, month 2, month 3]
• Head circumference change [Срок оценки: day 0, month 1, month 2, month 3]
• BMI change [Срок оценки: day 0, month 1, month 2, month 3]
• Frequency of depositions [Срок оценки: day 0, month 1, month 2, month 3]
• Consistency of stools [Срок оценки: day 0, month 1, month 2, month 3]
• Infant colic [Срок оценки: day 0, month 1, month 2, month 3]
• Vomiting [Срок оценки: day 0, month 1, month 2, month 3]
• Sleeping habits [Срок оценки: day 0, month 1, month 2, month 3]
• Incidence of infections [Срок оценки: day 0, month 1, month 2, month 3]
• Fever [Срок оценки: day 0, month 1, month 2, month 3]
• Antibiotics [Срок оценки: day 0, month 1, month 2, month 3]

Критерии участия

Критерии включения

• Healthy infants
• 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

Критерии исключения

• Infants participating in other clinical study
• 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)

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Четверное слепое

Основная цель

Другое

Центры проведения

Мексика · 1 центр

• Instituto Nacional de Pediatría Insurgentes Sur 3700-C, Insurgentes Cuicuilco — Alcaldía Coyoacán

Испания · 1 центр

• Clínica Viamed Montecanal — Zaragoza

Публикации

• 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. PMID 34568236
• 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. PMID 21150647
• 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. PMID 32727119
• 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. PMID 32443684
• 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. PMID 26832746
• 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. PMID 28002391

Идентификаторы

NCT: NCT05524649 · AB-BABYCARE-21

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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