Effect of Galactooligosaccharides on Incidence of Atopic... | NCT02077088

Studies
Effect of Galactooligosaccharides on Incidence of Atopic Manifestations in Infants

NCT02077088

Sponsor

Humana Co.Ltd.

Status

Completed

Last Update Posted

Mar 4, 2014Estimated

Enrollment

120Actual

Phase

Not Applicable

Conditions

Atopic Dermatitis

Interventions

galactooligosaccharide

Countries

Czechia

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2014

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2009

Primary Completion Date

Nov 2012Actual

Completion Date

Apr 2013Actual

First Submitted Date

Jan 2, 2014

First Submission Date that Met QC Criteria

Feb 28, 2014

First Posted Date

Mar 4, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 28, 2014

Last Update Posted Date

Mar 4, 2014Estimated

Name	Class
Vitkovice Hospital	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

120Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Galactooligosaccharides	Experimental	addition of 0,5g galactooligosaccharides to HA (hypoallergenic) starter formula	Other: galactooligosaccharide
Only HA formula	No Intervention	only standard HA starter formula

Interventions

Name	Type	Description	Arm Group Labels	Other Names
galactooligosaccharide	Other	addition of food grade GRAS (Generally Regarded As Safe) galactooligosaccharides	Galactooligosaccharides

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Measure	Description	Time Frame
incidence of febrile episodes		at 6 months

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

6 Weeks

Maximum Age

8 Weeks

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Jan Bozensky, MD	Vitkovice Hospital, Ostrava, Czech Republic	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Vitkovice Hospital		Ostrava-Vitkovice		70384	Czechia

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
26571488	Derived	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.

ID	Term
D003876	Dermatitis, Atopic
D003872	Dermatitis

ID	Term
D012873	Skin Diseases, Genetic
D030342	Genetic Diseases, Inborn
D009358	Congenital, Hereditary, and Neonatal Diseases and Abnormalities
D012871	Skin Diseases

ID	Term
C072242	4'-galactooligosaccharide
D056692	Prebiotics

ID	Term
D004043	Dietary Fiber
D004040	Dietary Carbohydrates
D002241	Carbohydrates
D011135	Polysaccharides, Bacterial