Health TrialsbyHealthPanel

Effect of Probiotics on Infant's Fecal Microbiota Composition

ConditionMicrobial Colonization
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age1-90
SponsorAB Biotics, SA

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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)

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Food Supplement 1

    Dietary supplement

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

  • Food Supplement 2

    Dietary supplement

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

  • Placebo

    Dietary supplement

    5 drops/day for 3 months of sunflower oil

Treatment groups

120 Participants
are divided into 3 treatment groups
Group A: Experimental 1Experimental treatment 1 intervention
Group B: Experimental 2Experimental treatment 1 intervention
Group C: PlaceboPlacebo comparator 1 intervention

Trial outcomes

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

Time frame
day 0, month 3

Secondary outcomes

1

Weight change

Change in weight (g per day) between day 0 and month 3

Time frame
day 0, month 1, month 2, month 3
2

Length change

Change in length (cm) between day 0 and month 3

Time frame
day 0, month 1, month 2, month 3
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
4

BMI change

Change in BMI (kg/m2) between day 0 and month 3

Time frame
day 0, month 1, month 2, month 3

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

AB Biotics, SA

Lead sponsor

Ministry of Science and Innovation, Spain

Collaborator

Source ClinicalTrials.gov
Apply now