Evaluation of Probiotics on Symptoms of Upper Respiratory Tract Infections

January 11, 2008 updated by: Danisco

Probiotics and Effects on Illness-Related Symptoms for Pre-School Age Children

The aim of the present prospective study is to investigate whether the consumption of certain probiotic strains over a six-month winter/spring season would be able to affect the incidence and duration of upper respiratory tract infections, in otherwise healthy children as well as determining whether a combination of two strains would perform differently from a single strain version.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

326

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Zhejiang
      • Jinhua City, Zhejiang, China
        • Day care center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

3 years to 5 years (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Children aged 3-5 years of normal nutritional status and health

Exclusion Criteria:

  • Contraindications to dairy products (lactose intolerance or cow's milk allergy)
  • Indicators of inflammatory disease, intestinal disease, Crohn's disease, colitis, celiac disease
  • Chronic cough from recurring respiratory distress-related diseases
  • Hirschsprung's disease
  • Cystic fibrosis
  • Other metabolic, neurological, or anatomic alteration that predisposes participation
  • Intake of probiotics within the last 3 weeks

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: 1
Placebo
Dietary supplement: Placebo
Inert excipient
Active Comparator: Active 1
One probiotic strain
Dietary supplement: Lactobacillus acidophilus NCFM
1e10 CFU/day
Active Comparator: Active 2
Blend of two strains
Dietary supplement: Combination of Lactobacillus acidophilus and Bifidobacterium lactis
1x10e10 CFU/day

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
To examine if the consumption of two different probiotic strains added to milk at the point of consumption could reduce the "flu-like" symptoms and other symptoms of illness of preschool-age children in day care centers.
Time Frame: Daily for six months
Daily for six months

Secondary Outcome Measures

Outcome Measure
Time Frame
To determine if children who consume a beverage fortified with a probiotic miss fewer days of preschool as measured by illness.
Time Frame: Six months
Six months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Danisco

Investigators

  • Study Director: Charlie Zhang, Sprim Advanced Life Sciences
  • Study Chair: Cheryl Riefer, Sprim Advanced Life Sciences

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2005

Primary Completion (Actual)

May 1, 2006

Study Completion (Actual)

May 1, 2006

Study Registration Dates

First Submitted

January 3, 2008

First Submitted That Met QC Criteria

January 11, 2008

First Posted (Estimate)

January 23, 2008

Study Record Updates

Last Update Posted (Estimate)

January 23, 2008

Last Update Submitted That Met QC Criteria

January 11, 2008

Last Verified

January 1, 2008

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • Danisco - Mao
  • 06-02-D-011

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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