Impact of Probiotics on Infant Gut Health
Safety, Tolerability and Effect on Fecal Microbiota Composition of Two Probiotic Strains in Infants
NA · AB Biotics, SA · NCT05524649
This study is testing whether giving healthy infants two types of probiotics can improve their gut health and overall well-being over three months.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Ages | 1 Day to 90 Days |
| Sex | All |
| Sponsor | AB Biotics, SA (industry) |
| Locations | 2 sites (Alcaldía Coyoacán, Puebla and 1 other locations) |
| Trial ID | NCT05524649 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effects of two specific probiotic strains, Bifidobacterium longum and Pediococcus pentosaceus, on the fecal microbiota composition in healthy infants aged 60 to 90 days. The study is designed as a double-blind, randomized, placebo-controlled trial, where participants will be assigned to receive one of the probiotics or a placebo for a duration of three months. Secondary outcomes include assessments of growth, digestive tolerance, sleep patterns, and the incidence of gastrointestinal and respiratory infections, as well as safety and tolerability of the probiotics.
Who should consider this trial
Good fit: Ideal candidates are healthy infants aged between 60 and 90 days who meet specific inclusion criteria.
Not a fit: Infants with existing digestive diseases or those who have recently taken antibiotics or probiotics may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance infant gut health and reduce the incidence of gastrointestinal issues and infections.
How similar studies have performed: Previous studies have shown promising results with probiotics in improving gut health in infants, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion 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)
Where this trial is running
Alcaldía Coyoacán, Puebla and 1 other locations
- Instituto Nacional de Pediatría Insurgentes Sur 3700-C, Insurgentes Cuicuilco — Alcaldía Coyoacán, Puebla, Mexico (NOT_YET_RECRUITING)
- Clínica Viamed Montecanal — Zaragoza, Aragon, Spain (RECRUITING)
Study contacts
- Study coordinator: Gerardo Rodríguez Martínez, MD
- Email: gerard@unizar.es
- Phone: 654633910
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Microbial Colonization, Probiotics, Infants, Microbiota