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Recruiting NCT05524649

Effect of Probiotics on Infant's Fecal Microbiota Composition

No phase Interventional Microbial Colonization

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Food Supplement 1, Food Supplement 2, Placebo.
Who it may be relevant to
Registry conditions: Microbial Colonization. Basic parameters: 1 Day — 90 Days · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Mexico, Spain
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

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

Primary outcome measures

  • Change of Bifidobacterium longum and Pediococcus pentosaceus in feces [Time frame: day 0, month 3]
Secondary outcome measures (12)
  • Weight change [Time frame: day 0, month 1, month 2, month 3]
  • Length change [Time frame: day 0, month 1, month 2, month 3]
  • Head circumference change [Time frame: day 0, month 1, month 2, month 3]
  • BMI change [Time frame: day 0, month 1, month 2, month 3]
  • Frequency of depositions [Time frame: day 0, month 1, month 2, month 3]
  • Consistency of stools [Time frame: day 0, month 1, month 2, month 3]
  • Infant colic [Time frame: day 0, month 1, month 2, month 3]
  • Vomiting [Time frame: day 0, month 1, month 2, month 3]
  • Sleeping habits [Time frame: day 0, month 1, month 2, month 3]
  • Incidence of infections [Time frame: day 0, month 1, month 2, month 3]
  • Fever [Time frame: day 0, month 1, month 2, month 3]
  • Antibiotics [Time frame: day 0, month 1, month 2, month 3]

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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Quadruple blind
Primary purpose
Other

Study locations

Mexico · 1 center
  • Instituto Nacional de Pediatría Insurgentes Sur 3700-C, Insurgentes Cuicuilco — Alcaldía Coyoacán
Spain · 1 center
  • Clínica Viamed Montecanal — Zaragoza

Publications

  • 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

Identifiers

NCT: NCT05524649 · AB-BABYCARE-21

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗