Effect of Probiotics on Infant's Fecal Microbiota Composition

Microbial Colonization Clinical Trial

— BABYCARE  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05524649
• Other study ID #: AB-BABYCARE-21
• Status: Recruiting
• Phase: N/A
• Start date: June 1, 2022
• Est. completion date: December 31, 2024

Study information

• Verified date: October 2023
• Source: AB Biotics, SA
• Contact: Gerardo Rodríguez Martínez, MD
• Phone: 654633910
• Email: gerard[@]unizar.es
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: December 31, 2024
• Est. primary completion date: August 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 60 Days to 90 Days

Eligibility

Inclusion Criteria:

• Healthy infants

• Age between 60 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)

Related Conditions & MeSH terms

• Communicable Diseases
• Infections
• Microbial Colonization

Intervention

Dietary Supplement:
• 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

Locations

Country	Name	City	State
Spain	Clínica Viamed Montecanal	Zaragoza	Aragón

Sponsors (2)

Lead Sponsor	Collaborator
AB Biotics, SA	Centre for the Development of Industrial Technology, Ministry of Science and Innovation, Spain

Country where clinical trial is conducted

Spain, 

References & Publications (6)

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. — View Citation

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 Clin — View 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. — View Citation

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 — View 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. — View 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. Pedi — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Weight change	Change in weight (g per day) between day 0 and month 3	day 0, month 1, month 2, month 3
Secondary	Length change	Change in length (cm) between day 0 and month 3	day 0, month 1, month 2, month 3
Secondary	Head circumference change	Change in head circumference (cm) between day 0 and month 3	day 0, month 1, month 2, month 3
Secondary	BMI change	Change in BMI (kg/m2) between day 0 and month 3	day 0, month 1, month 2, month 3
Secondary	Frequency of depositions	Frequency of depositions (number stools/day) documented in participants diary	day 0, month 1, month 2, month 3
Secondary	Consistency of stools	Consistency of stools through a 5-item scale: 1= hard balls, 2=hard-formed, 3=soft-formed, 4=half liquid and 5=liquid	day 0, month 1, month 2, month 3
Secondary	Infant colic	Incidence of infant colic, defined as prolonged and recurrent periods of crying, agitation, or irritability without apparent cause that cannot be prevented or resolved by your caregivers, for three or more hours daily for three or more days a week	day 0, month 1, month 2, month 3
Secondary	Vomiting	Incidence of vomiting (n/day)	day 0, month 1, month 2, month 3
Secondary	Sleeping habits	Nocturnal sleeping (min/day), total sleeping hours (min/day)	day 0, month 1, month 2, month 3
Secondary	Incidence of infections	Number and duration (in days) of any type of infectious episodes	day 0, month 1, month 2, month 3
Secondary	Fever	Number of days with fever (axial body temperature higher than 37.5 ºC)	day 0, month 1, month 2, month 3
Secondary	Antibiotics	Number of days with antibiotic treatment	day 0, month 1, month 2, month 3
Secondary	Change in fecal microbiota composition	Analysis of a y ß biodiversity, relative abundance of bacteria determined by 16S sequencing	day 0, month 3
Secondary	sIgA in stool samples	Analysis of secretory Immunoglobulin A (sIgA) in stools through ELISA	day 0, month 3
Secondary	Calprotectin	Analysis of fecal calprotectin through ELISA	day 0, month 3