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Combined Lactobacilli (Reuteri LMG P-27481 and GG ATCC 53103) to Prevent Antibiotic Associated Symptoms in Children

NCT04836013 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 216

Last updated 2021-05-04

No results posted yet for this study

Summary

This is a prospective multicenter pediatric double-blind, randomized placebo-controlled, parallel group clinical trial intended to evaluate the efficacy, safety and tolerability of a combined probiotic (LGG and L. reuteri LMG P-27481) in the prevention of antibiotic associated diarrhea and gastrointestinal symptoms in hospitalised children treated with antibiotics for proven or suspected bacterial infection.

Conditions

Interventions

DIETARY_SUPPLEMENT

combined Lactobacilli

1 oral stick per day for 30 days starting the day of antibiotic treatment

OTHER

Placebo

1 oral stick per day for 30 days starting the day of antibiotic treatment

Sponsors & Collaborators

  • Università degli Studi dell'Insubria

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
12 Months
Max Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-05-13
Primary Completion
2021-11-30
Completion
2022-04-13

Countries

  • Italy

Study Locations

More Related Trials

Entities

Diseases

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 NCT04836013 on ClinicalTrials.gov