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Effect and Tolerability of Lactobacillus Rhamnosus GG LA801 for the Preventive Nutritional Care of Nosocomial Diarrhea in Children

NCT04628819 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 61

Last updated 2021-04-20

No results posted yet for this study

Summary

One of the most common infections acquired in hospital, also known as nosocomial infections, is intestinal infections. These infections can lead to the development of nosocomial diarrhea which can have serious consequences in young / very young children. These infections tend to prolong the average length of hospital stay of this fragile population. Conventional treatment of these infections, in the absence of knowledge of the infectious agent, is purely symptomatic. It is therefore necessary to develop new prevention strategies for this type of disease. In this sense, the administration of probiotic strains in order to prevent the onset of nosocomial diarrhea is a promising avenue and the present study aims to validate the preventive effect of this supplement.

The objective of this study is to assess the effect of Babybiane® Imedia or the microbiotic strain Lactobacillus rhamnosus GG LA801 in the preventive nutritional management of nosocomial diarrhea in children aged 1 to 24 months. This evaluation will be made in comparison with a placebo. The tolerance of the product under study will also be assessed.

Conditions

  • Nosocomial Infection
  • Diarrhea, Infantile

Interventions

DIETARY_SUPPLEMENT

Babybiane Imedia or placebo

Both the investigational product as well as the placebo will be administered once daily, diluted in a nursing bottle or a glass of water or cold milk, or mixed with a food suitable for the child. It may be diluted in oral rehydration solution and is to be taken preferably before a meal. Both preparations (BABYBIANE® Imedia and placebo) will have similar consistency and taste. A supplementation unit will contain 7 packs of either products, one per supplementation day.

Sponsors & Collaborators

  • Clinact

    collaborator OTHER

  • Clinfile

    collaborator INDUSTRY

  • PiLeJe

    lead INDUSTRY

Principal Investigators

  • Alexis Mosca, MD · Hopital Universitaire Robert-Debre

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
1 Month
Max Age
24 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-12-29
Primary Completion
2020-04-01
Completion
2020-04-01

Countries

  • France

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 NCT04628819 on ClinicalTrials.gov