Effect of Galactooligosaccharides on Incidence of Atopic Manifestations in Infants

February 28, 2014 updated by: Humana Co.Ltd.

Double Blind, Randomised Study on the Effect of Prebiotics on Incidence of Atopic Manifestations in Infants

Addition of prebiotic galactooligosaccharides to hypoallergenic starter formula would lead to decreased allergic (atopic) symptoms in nonbreastfed infants with a positive history of allergy in family

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

120

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

  • Czech Republic
      • Ostrava-Vitkovice, Czech Republic, 70384
        • Vitkovice Hospital

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

1 month to 1 month (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • nonbreastfed eutrophic infants of corresponding gestational age
  • presence of a positive family allergic anamnesis in parents or siblings (atopic eczema, allergic rhinitis or bronchial asthma)

Exclusion Criteria:

  • children with serious disease,
  • breastfed children
  • children fed another formula then the ones used

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: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Galactooligosaccharides
addition of 0,5g galactooligosaccharides to HA (hypoallergenic) starter formula
Other: galactooligosaccharide
addition of food grade GRAS (Generally Regarded As Safe) galactooligosaccharides
Other Names:
  • GOS
  • prebiotics
No Intervention: Only HA formula
only standard HA starter formula

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
SCORAD (SCORing Atopic Dermatitis score) assessment of atopy
Time Frame: at 6 months of age
objective evaluation of atopic symptoms
at 6 months of age

Secondary Outcome Measures

Outcome Measure
Time Frame
anthropometric parameters (height, weight)
Time Frame: at 6 months of age
at 6 months of age

Other Outcome Measures

Outcome Measure
Time Frame
incidence of febrile episodes
Time Frame: at 6 months
at 6 months

Collaborators and Investigators

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

Sponsor

Humana Co.Ltd.

Collaborators

Vitkovice Hospital

Investigators

  • Principal Investigator: Jan Bozensky, MD, Vitkovice Hospital, Ostrava, Czech Republic

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

June 1, 2009

Primary Completion (Actual)

November 1, 2012

Study Completion (Actual)

April 1, 2013

Study Registration Dates

First Submitted

January 2, 2014

First Submitted That Met QC Criteria

February 28, 2014

First Posted (Estimate)

March 4, 2014

Study Record Updates

Last Update Posted (Estimate)

March 4, 2014

Last Update Submitted That Met QC Criteria

February 28, 2014

Last Verified

February 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1.090

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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