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Effect of Probiotics on Infant's Fecal Microbiota Composition

NCT05524649 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2025-02-11

No results posted yet for this study

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.

Conditions

  • Microbial Colonization

Interventions

DIETARY_SUPPLEMENT

Food Supplement 1

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

DIETARY_SUPPLEMENT

Food Supplement 2

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

DIETARY_SUPPLEMENT

Placebo

5 drops/day for 3 months of sunflower oil

Sponsors & Collaborators

  • Ministry of Science and Innovation, Spain

    collaborator OTHER_GOV

  • AB Biotics, SA

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
1 Day
Max Age
90 Days
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-06-01
Primary Completion
2025-08-31
Completion
2025-12-31

Countries

  • Mexico
  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05524649 on ClinicalTrials.gov