An interventional study of Food Supplement 1 and Food Supplement 2 in Microbial Colonization, sponsored by AB Biotics, SA. Recruiting at 2 sites in 2 countries. Open to participants aged 1 Day to 90 Days, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-02-11.
Sponsored by AB Biotics, SA (part of Kaneka Corporation) · Not applicable, Interventional, and Other
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.
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.
4,447 studies on the registry are indexed under Communicable Diseases; 514 are open to participants now.
This study's planned enrollment of 120 is close to the median of 121 across 2,712 interventional studies indexed under Communicable Diseases.
Browse Communicable Diseases studies →AB Biotics, SA is the lead sponsor of 26 studies on the registry; 4 are open to participants now.
First submitted after AB Biotics, SA became part of Kaneka Corporation.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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
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
Sunflower oil
Dietary Supplement: Placebo
Probiotic single strain formulation containing Bifidobacterium longum CECT7894 for 3 months 5 drops/day
Probiotic single strain formulation containing Pediococcus pentosaceus CECT8330 for 3 months 5 drops/day
5 drops/day for 3 months of sunflower oil
Change of Bifidobacterium longum and Pediococcus pentosaceus in feces
Change of total counts of Bifidobacterium longum and Pediococcus pentosaceus in feces determined by qPCR
Time frame: day 0, month 3
Weight change
Change in weight (g per day) between day 0 and month 3
Time frame: day 0, month 1, month 2, month 3
Length change
Change in length (cm) between day 0 and month 3
Time frame: day 0, month 1, month 2, month 3
Head circumference change
Change in head circumference (cm) between day 0 and month 3
Time frame: day 0, month 1, month 2, month 3
BMI change
Change in BMI (kg/m2) between day 0 and month 3
Time frame: day 0, month 1, month 2, month 3
Frequency of depositions
Frequency of depositions (number stools/day) documented in participants diary
Time frame: day 0, month 1, month 2, month 3
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
Time frame: day 0, month 1, month 2, month 3
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
Time frame: day 0, month 1, month 2, month 3
Vomiting
Incidence of vomiting (n/day)
Time frame: day 0, month 1, month 2, month 3
Sleeping habits
Nocturnal sleeping (min/day), total sleeping hours (min/day)
Time frame: day 0, month 1, month 2, month 3
Incidence of infections
Number and duration (in days) of any type of infectious episodes
Time frame: day 0, month 1, month 2, month 3
Fever
Number of days with fever (axial body temperature higher than 37.5 ºC)
Time frame: day 0, month 1, month 2, month 3
Antibiotics
Number of days with antibiotic treatment
Time frame: day 0, month 1, month 2, month 3
Change in fecal microbiota composition
Analysis of α y β biodiversity, relative abundance of bacteria determined by 16S sequencing
Time frame: day 0, month 3
sIgA in stool samples
Analysis of secretory Immunoglobulin A (sIgA) in stools through ELISA
Time frame: day 0, month 3
Calprotectin
Analysis of fecal calprotectin through ELISA
Time frame: day 0, month 3
Plan to share: No
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