Clinical trial NCT05524649: Effect of Probiotics on Infant's Fecal Microbiota Composition
Official title: Safety, Tolerability and Effect on Fecal Microbiota Composition of Two Probiotic Strains in Infants
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Microbial Colonization
Keywords: Probiotics
Infants
Microbiota
Lead sponsor: AB Biotics, SA
Sponsor class: INDUSTRY
Collaborators: name: Ministry of Science and Innovation, Spain
First posted: 2022-09-01
Enrollment: 120
Sex: ALL
Minimum age (years): 1
Maximum age (years): 90
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Double-blind, randomized, placebo-controlled trial in 120 healthy infants between 1 and 90 days of age, who will be allocated to receive either one of the probiotic strains or placebo for 3 months
Primary purpose: OTHER

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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)

Primary outcomes:
measure: Change of Bifidobacterium longum and Pediococcus pentosaceus in feces
timeFrame: day 0, month 3
Secondary outcomes:
measure: Weight change
timeFrame: day 0, month 1, month 2, month 3
measure: Length change
timeFrame: day 0, month 1, month 2, month 3
measure: Head circumference change
timeFrame: day 0, month 1, month 2, month 3
measure: BMI change
timeFrame: day 0, month 1, month 2, month 3
measure: Frequency of depositions
timeFrame: day 0, month 1, month 2, month 3
measure: Consistency of stools
timeFrame: day 0, month 1, month 2, month 3
measure: Infant colic
timeFrame: day 0, month 1, month 2, month 3
measure: Vomiting
timeFrame: day 0, month 1, month 2, month 3
measure: Sleeping habits
timeFrame: day 0, month 1, month 2, month 3
measure: Incidence of infections
timeFrame: day 0, month 1, month 2, month 3
measure: Fever
timeFrame: day 0, month 1, month 2, month 3
measure: Antibiotics
timeFrame: day 0, month 1, month 2, month 3
measure: Change in fecal microbiota composition
timeFrame: day 0, month 3
measure: sIgA in stool samples
timeFrame: day 0, month 3
measure: Calprotectin
timeFrame: day 0, month 3
Other outcomes:
Locations:
city: Alcaldía Coyoacán
country: Mexico
facility: Instituto Nacional de Pediatría Insurgentes Sur 3700-C, Insurgentes Cuicuilco
state: Puebla
city: Zaragoza
country: Spain
facility: Clínica Viamed Montecanal
state: Aragón
Study officials:
References:
citation: 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.
citation: 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.
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citation: 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.
citation: 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.