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Effect of Galactooligosaccharides on Incidence of Atopic Manifestations in Infants

Primary Purpose

Atopic Dermatitis

Status

Completed

Phase

Not Applicable

Locations

Czech Republic

Study Type

Interventional

Intervention

galactooligosaccharide

About this trial

This is an interventional prevention trial for Atopic Dermatitis focused on measuring interventional, doubleblind, randomised, pediatric, prebiotic, atopic, dermatitis, infant

Eligibility Criteria

6 Weeks - 8 Weeks (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Vitkovice Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Galactooligosaccharides

Only HA formula

Arm Description

addition of 0,5g galactooligosaccharides to HA (hypoallergenic) starter formula

only standard HA starter formula

Outcomes

Primary Outcome Measures

SCORAD (SCORing Atopic Dermatitis score) assessment of atopy

objective evaluation of atopic symptoms

Secondary Outcome Measures

anthropometric parameters (height, weight)

Full Information

NCT ID

NCT02077088

First Posted

January 2, 2014

Last Updated

February 28, 2014

Sponsor

Humana Co.Ltd.

Collaborators

Vitkovice Hospital

1. Study Identification

Unique Protocol Identification Number

NCT02077088

Brief Title

Effect of Galactooligosaccharides on Incidence of Atopic Manifestations in Infants

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2014

Overall Recruitment Status

Completed

Study Start Date

June 2009 (undefined)

Primary Completion Date

November 2012 (Actual)

Study Completion Date

April 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Humana Co.Ltd.

Collaborators

Vitkovice Hospital

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Atopic Dermatitis

Keywords

interventional, doubleblind, randomised, pediatric, prebiotic, atopic, dermatitis, infant

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

120 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Galactooligosaccharides

Arm Type

Experimental

Arm Description

addition of 0,5g galactooligosaccharides to HA (hypoallergenic) starter formula

Arm Title

Only HA formula

Arm Type

No Intervention

Arm Description

only standard HA starter formula

Intervention Type

Other

Intervention Name(s)

galactooligosaccharide

Other Intervention Name(s)

GOS, prebiotics

Intervention Description

addition of food grade GRAS (Generally Regarded As Safe) galactooligosaccharides

Primary Outcome Measure Information:

Title

SCORAD (SCORing Atopic Dermatitis score) assessment of atopy

Description

objective evaluation of atopic symptoms

Time Frame

at 6 months of age

Secondary Outcome Measure Information:

Title

anthropometric parameters (height, weight)

Time Frame

at 6 months of age

Other Pre-specified Outcome Measures:

Title

incidence of febrile episodes

Time Frame

at 6 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

6 Weeks

Maximum Age & Unit of Time

8 Weeks

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jan Bozensky, MD

Organizational Affiliation

Vitkovice Hospital, Ostrava, Czech Republic

Official's Role

Principal Investigator

Facility Information:

Facility Name

Vitkovice Hospital

City

Ostrava-Vitkovice

ZIP/Postal Code

70384

Country

Czech Republic

12. IPD Sharing Statement

Citations:

PubMed Identifier

26571488

Citation

Bozensky J, Hill M, Zelenka R, Skyba T. Prebiotics Do Not Influence the Severity of Atopic Dermatitis in Infants: A Randomised Controlled Trial. PLoS One. 2015 Nov 16;10(11):e0142897. doi: 10.1371/journal.pone.0142897. eCollection 2015.

Results Reference

derived

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Effect of Galactooligosaccharides on Incidence of Atopic Manifestations in Infants

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