NCT05524649 Effect of Probiotics on Infant's Fecal Microbiota Composition
| NCT ID | NCT05524649 |
| Status | Recruiting |
| Phase | — |
| Sponsor | AB Biotics, SA |
| Condition | Microbial Colonization |
| Study Type | INTERVENTIONAL |
| Enrollment | 120 participants |
| Start Date | 2022-06-01 |
| Primary Completion | 2025-08-31 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 120 participants in total. It began in 2022-06-01 with a primary completion date of 2025-08-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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)
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05524649 clinical trial?
This trial is open to participants of all sexes, aged 1 Day or older, up to 90 Days, studying Microbial Colonization. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05524649 currently recruiting?
Yes, NCT05524649 is actively recruiting participants. Contact the research team at gerard@unizar.es for enrollment information.
Where is the NCT05524649 trial being conducted?
This trial is being conducted at Alcaldía Coyoacán, Mexico, Zaragoza, Spain.
Who is sponsoring the NCT05524649 clinical trial?
NCT05524649 is sponsored by AB Biotics, SA. The trial plans to enroll 120 participants.