Effect of Probiotics on Infant's Fecal Microbiota Composition
- Conditions
- Microbial Colonization
- Interventions
- Dietary Supplement: Food Supplement 1Dietary Supplement: Food Supplement 2Dietary Supplement: Placebo
- Registration Number
- NCT05524649
- Lead Sponsor
- AB Biotics, SA
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 120
- 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
- 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)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Experimental 1 Food Supplement 1 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. Experimental 2 Food Supplement 2 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. Placebo Placebo Sunflower oil
- Primary Outcome Measures
Name Time Method Change of Bifidobacterium longum and Pediococcus pentosaceus in feces day 0, month 3 Change of total counts of Bifidobacterium longum and Pediococcus pentosaceus in feces determined by qPCR
- Secondary Outcome Measures
Name Time Method Weight change day 0, month 1, month 2, month 3 Change in weight (g per day) between day 0 and month 3
Length change day 0, month 1, month 2, month 3 Change in length (cm) between day 0 and month 3
Head circumference change day 0, month 1, month 2, month 3 Change in head circumference (cm) between day 0 and month 3
BMI change day 0, month 1, month 2, month 3 Change in BMI (kg/m2) between day 0 and month 3
Frequency of depositions day 0, month 1, month 2, month 3 Frequency of depositions (number stools/day) documented in participants diary
Consistency of stools day 0, month 1, month 2, month 3 Consistency of stools through a 5-item scale: 1= hard balls, 2=hard-formed, 3=soft-formed, 4=half liquid and 5=liquid
Infant colic day 0, month 1, month 2, month 3 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
Incidence of infections day 0, month 1, month 2, month 3 Number and duration (in days) of any type of infectious episodes
Vomiting day 0, month 1, month 2, month 3 Incidence of vomiting (n/day)
Fever day 0, month 1, month 2, month 3 Number of days with fever (axial body temperature higher than 37.5 ºC)
Antibiotics day 0, month 1, month 2, month 3 Number of days with antibiotic treatment
Change in fecal microbiota composition day 0, month 3 Analysis of α y β biodiversity, relative abundance of bacteria determined by 16S sequencing
sIgA in stool samples day 0, month 3 Analysis of secretory Immunoglobulin A (sIgA) in stools through ELISA
Calprotectin day 0, month 3 Analysis of fecal calprotectin through ELISA
Sleeping habits day 0, month 1, month 2, month 3 Nocturnal sleeping (min/day), total sleeping hours (min/day)
Trial Locations
- Locations (2)
Clínica Viamed Montecanal
🇪🇸Zaragoza, Aragón, Spain
Instituto Nacional de Pediatría Insurgentes Sur 3700-C, Insurgentes Cuicuilco
🇲🇽Alcaldía Coyoacán, Puebla, Mexico