Microbial Colonization
Conditions
Keywords
Probiotics, Infants, Microbiota
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.
Interventions
DIETARY_SUPPLEMENTFood Supplement 1
Probiotic single strain formulation containing Bifidobacterium longum CECT7894 for 3 months 5 drops/day
DIETARY_SUPPLEMENTFood Supplement 2
Probiotic single strain formulation containing Pediococcus pentosaceus CECT8330 for 3 months 5 drops/day
DIETARY_SUPPLEMENTPlacebo
5 drops/day for 3 months of sunflower oil
Sponsors
Ministry of Science and Innovation, Spain
AB Biotics, SA
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Every product will be provided in identical packaging
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
Eligibility
Sex/Gender
ALL
Age
1 Days to 90 Days
Healthy volunteers
Yes
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
| Vomiting | day 0, month 1, month 2, month 3 | Incidence of vomiting (n/day) |
| Head circumference change | day 0, month 1, month 2, month 3 | Change in head circumference (cm) between day 0 and month 3 |
| Incidence of infections | day 0, month 1, month 2, month 3 | Number and duration (in days) of any type of infectious episodes |
| 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) |
Countries
Mexico, Spain
Contacts
Primary ContactGerardo Rodríguez Martínez, MD
Backup ContactMeritxell Aguilo Garcia, PhD
Outcome results
None listed