NCT05524649

Effect of Probiotics on Infant's Fecal Microbiota Composition

Name: Clinical Trial NCT05524649
Creator: AB Biotics, SA
Keywords: Microbial Colonization, Food Supplement 1, dietary supplement, clinical trial, Spain

Safety, Tolerability and Effect on Fecal Microbiota Composition of Two Probiotic Strains in Infants

AB Biotics, SA·ClinicalTrials.gov·dietary supplementRecruiting

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Study focus

Disease/Condition: Microbial Colonization
Drug/Device/Intervention: Food Supplement 1
Study type: Interventional
Intervention type: dietary supplement

Sponsor & location

Primary sponsor: AB Biotics, SA
Location: Zaragoza, Spain

Timeline & enrollment

Phase: N/A
Start date: Jun 01, 2022
End date: Dec 31, 2023
Enrollment: 120 participants

Primary outcome

Change of Bifidobacterium longum and Pediococcus pentosaceus in feces

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.

ICD-10 classifications

Bacterial infection of unspecified siteOther bacterial infections of unspecified siteBacterial, viral and other infectious agentsCholeraOther specified bacterial intestinal infections

Data source

Registry: ClinicalTrials.gov
Trial ID: NCT05524649
Type: Non-Device Trial

About this record

Access comprehensive clinical trial information for NCT05524649 through Pure Global AI's free database. This phase not specified trial is sponsored by AB Biotics, SA and is currently Recruiting. The study focuses on Microbial Colonization. Target enrollment is 120 participants.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.