NCT01148667

Brief Summary

Hypothesis: Probiotics have been used as novel adjunct therapeutic approach in atopic dermatitis. In addition to balancing the gut microecology and promoting host immune defences, specific probiotics might further aid in controlling the microbial colonization of the skin, thereby reducing proneness to secondary infections which typically cause sustained symptoms. Thirty-nine infants with atopic dermatitis,randomized for a three-month-period in a double-blind design to receive extensively hydrolysed casein formula (NutramigenR, Mead-Johnson, USA) supplemented with (n=19) or without (n=20) Lactobacillus rhamnosus GG (ATCC 53103) 5.0 x 107 cfu/g to achieve a daily intake of 3.4 x 109 cfu. Sampling (blood and faecal samples, cotton swab from the skin) and clinical examination of the infant, including SCORAD assessment to determine the severity of atopic dermatitis, at each study visit (at entry and one month and three months thereafter).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Mar 2007

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2007

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2008

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

June 21, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 22, 2010

Completed
Last Updated

June 22, 2010

Status Verified

June 1, 2010

Enrollment Period

1.3 years

First QC Date

June 21, 2010

Last Update Submit

June 21, 2010

Conditions

Gut MicrobiotaSkin MicrobiotaHumoral Immune ResponsesSeverity of Atopic Dermatitis

Keywords

atopic dermatitisbarrier functiongutprobioticsskin

Outcome Measures

Primary Outcomes (1)

  • severity of atopic dermatitis

    Severity of atopic dermatitis of the study infants will be assessed by SCORAD index

    March 2007 - July 2008

Secondary Outcomes (1)

  • Maturation of humoral immune responses

    March 2007 - July 2008

Study Arms (2)

Infants drink formula added with LGG

ACTIVE COMPARATOR

Infants have been randomized (1:1) to get casein hydrolysate with or without LGG

Dietary Supplement: Casein hydrolysate added with LGG

Infants drink casein hydrolysate without LGG

PLACEBO COMPARATOR

Infants get extensively hydrolysed casein formula

Dietary Supplement: Infants drink casein hydrolysate without LGG

Interventions

Casein hydrolysate added with LGGDIETARY_SUPPLEMENT

Infants drink extensively hydrolysed casein formula supplemented with LGG (ATCC 53103) 5.0 x 10 7 cfu/g to achieve a daily intake of 3.4 10 9 cfu.

Infants drink formula added with LGG
Infants drink casein hydrolysate without LGGDIETARY_SUPPLEMENT

Infants drink extensively hydrolysed casein formula without added LGG

Infants drink casein hydrolysate without LGG

Eligibility Criteria

Age4 Weeks - 18 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • clinical diagnosis of atopic dermatitis
  • age 4 we - 18 mo

You may not qualify if:

  • skin infection or severe infection at the time of enrollment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Turku University Central Hospital

Turku, 20520, Finland

Location

Related Publications (1)

  • Nermes M, Kantele JM, Atosuo TJ, Salminen S, Isolauri E. Interaction of orally administered Lactobacillus rhamnosus GG with skin and gut microbiota and humoral immunity in infants with atopic dermatitis. Clin Exp Allergy. 2011 Mar;41(3):370-7. doi: 10.1111/j.1365-2222.2010.03657.x. Epub 2010 Dec 1.

    PMID: 21121981DERIVED

MeSH Terms

Conditions

Dermatitis, Atopic

Condition Hierarchy (Ancestors)

Skin Diseases, GeneticGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesDermatitisSkin DiseasesSkin and Connective Tissue DiseasesSkin Diseases, EczematousHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

June 21, 2010

First Posted

June 22, 2010

Study Start

March 1, 2007

Primary Completion

July 1, 2008

Study Completion

July 1, 2008

Last Updated

June 22, 2010

Record last verified: 2010-06

Locations

FI(1)