Effect of Probiotics on Infant's Fecal Microbiota Composition

NCT05524649 | Recruiting

• 1 other identifier: AB-BABYCARE-21
• Study Type: interventional
• Target: 120
• Locations: 2 countries
• Sites: 2

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.

Conditions

Microbial Colonization

Keywords

Probiotics; Infants; Microbiota

Outcome Measures

Primary Outcomes (1)

• Change of Bifidobacterium longum and Pediococcus pentosaceus in feces

  Change of total counts of Bifidobacterium longum and Pediococcus pentosaceus in feces determined by qPCR

  day 0, month 3

Secondary Outcomes (15)

• Weight change

  day 0, month 1, month 2, month 3

• Length change

  day 0, month 1, month 2, month 3

• Head circumference change

  day 0, month 1, month 2, month 3

• BMI change

  day 0, month 1, month 2, month 3

• Frequency of depositions

  day 0, month 1, month 2, month 3

Study Arms (3)

Experimental 1

EXPERIMENTAL

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.

Dietary Supplement: Food Supplement 1

Experimental 2

EXPERIMENTAL

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.

Dietary Supplement: Food Supplement 2

Placebo

PLACEBO COMPARATOR

Sunflower oil

Dietary Supplement: Placebo

Interventions

Food Supplement 1 DIETARY_SUPPLEMENT

Probiotic single strain formulation containing Bifidobacterium longum CECT7894 for 3 months 5 drops/day

Experimental 1

Food Supplement 2 DIETARY_SUPPLEMENT

Probiotic single strain formulation containing Pediococcus pentosaceus CECT8330 for 3 months 5 drops/day

Experimental 2

Placebo DIETARY_SUPPLEMENT

5 drops/day for 3 months of sunflower oil

Placebo

Eligibility Criteria

• Age: 1 Day - 90 Days
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• AB Biotics, SA: lead
• Ministry of Science and Innovation, Spain: collaborator

Study Sites (2)

Instituto Nacional de Pediatría Insurgentes Sur 3700-C, Insurgentes Cuicuilco

Alcaldía Coyoacán, Puebla, 04530, Mexico

NOT YET RECRUITING

Clínica Viamed Montecanal

Zaragoza, Aragon, 50012, Spain

RECRUITING

Related Publications (6)

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

MeSH Terms

Conditions

Communicable Diseases

Condition Hierarchy (Ancestors)

Infections; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Gerardo Rodríguez Martínez, MD

CONTACT

654633910; gerard@unizar.es

Meritxell Aguilo Garcia, PhD

CONTACT

+34902903844; aguilo@ab-biotics.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Every product will be provided in identical packaging
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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

Study Record Dates

• First Submitted: August 26, 2022
• First Posted: September 1, 2022
• Study Start: June 1, 2022
• Primary Completion: August 31, 2025
• Study Completion: December 31, 2025
• Last Updated: February 11, 2025

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1); ME (1)