Effect of Probiotics on Infant's Fecal Microbiota Composition

Launched by AB BIOTICS, SA · Aug 30, 2022

Keywords

ClinConnect Summary

This clinical trial is studying the effects of two types of probiotics, which are good bacteria that can help with digestion, on the gut health of healthy infants. The researchers want to see how these probiotics can change the bacteria found in the waste of infants and if they can help with growth, sleeping habits, and even reduce the chance of getting stomach or respiratory infections. The trial also aims to ensure that the probiotics are safe and well-tolerated by the infants.

To participate in this study, infants need to be between 60 and 90 days old, healthy, and born at a normal weight. Parents will need to agree to follow the study's procedures and provide consent. However, infants who have been on certain antibiotics, have specific allergies, or are involved in other studies cannot participate. Parents can expect regular check-ups and monitoring throughout the trial to assess how their baby is doing with the probiotics. This is a great opportunity to contribute to understanding how probiotics can benefit young children's health!

Gender

ALL

Eligibility criteria

• 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)