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A Study on Efficacy of Feeding N1115 Probiotic Supplement to Young Children

NCT03416595 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2018-07-24

No results posted yet for this study

Summary

The aim of the study is to examine the intervening effects of N1115 Probiotic Supplement (containing Junlebao Lp. N1115) on gut development in young children at the age of 6 month to 3 years by the way of a randomised, double-blinded, parallel, placebo-controlled clinical trial, and to explore the change of intestinal microbiota composition and healthy condition after intervention.

Conditions

  • Intestinal Growth of Young Children

Interventions

DIETARY_SUPPLEMENT

N1115 Probiotic Supplement

Participators will receive a sachet each day during 8 weeks. The contents of the sachet should be added to warm water or milk, mixed until fully dissolved and served within 15 minutes.

DIETARY_SUPPLEMENT

placebo

Participators will receive a sachet each day during 8 weeks. The contents of the sachet should be added to warm water or milk, mixed until fully dissolved and served within 15 minutes.

Sponsors & Collaborators

  • Atlantia Food Clinical Trials

    collaborator INDUSTRY

  • Teagasc

    collaborator INDUSTRY

  • Junlebao Dairy Group Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Barry Skillington, Postgraduate · The director of this clinical trial in Ireland

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
6 Months
Max Age
3 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-09-18
Primary Completion
2018-09-30
Completion
2018-09-30

Countries

  • Ireland

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 NCT03416595 on ClinicalTrials.gov