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Probiotics Prevent Health Problems in Children

NCT04346576 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1036

Last updated 2020-04-15

No results posted yet for this study

Summary

Randomized controlled field trial of a probiotics to assess its roles in the prevention or improvement of constipation and diarrhea, acute respiratory infection, nutrition improving in Vietnam children.

In the present proposal, the investigators plan to examine if daily intake of a probiotic beverage, which includes 6.5 billion probiotic Lactobacilli, has a beneficial role in protecting children from infectious diarrhea and constipation in Vietnam with 3 objectives:

1. To assess the impact of probiotics in the prevention or improvement of diarrhea and constipation in children
2. To assess the impact of probiotics in the prevention of disease of respiratory system (ARI)
3. To assess the impact of probiotics on nutrition and growth of the children

Conditions

  • Gastrointestinal System Disease
  • Respiratory System

Interventions

DIETARY_SUPPLEMENT

Probiotics prevent health problems in children

A controlled field trial was conducted with 1,036 children (3-5 years old) in Thanh Hoa province in Vietnam. The probiotic group (n=518) consumed fermented milk 65 mL/day containing 108 CFU/mL of LcS for the 12-week intervention period, whereas the control group (n=493) were not given any. The incidence of constipation, diarrhea, ARI, and anthropometry in children was determined at baseline, after 4, 8, and 12-week intervention and after the 4-week follow-up period.

Sponsors & Collaborators

  • National Institute on Drug Abuse (NIDA)

    collaborator NIH

  • National Institute of Nutrition, Vietnam

    lead OTHER_GOV

Principal Investigators

  • Tuyen Le · National Institute of Nutrition

Study Design

Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
3 Years
Max Age
5 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-10-05
Primary Completion
2018-01-05
Completion
2018-06-05

Countries

  • Vietnam

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 NCT04346576 on ClinicalTrials.gov