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Lactobacillus Rhamnosus GG: Interaction With Human Microbiota and Immunity

Interaction of Orally Administered Lactobacillus Rhamnosus GG With Skin and Gut Microbiota and Humoral Immunity in Infants With Atopic Dermatitis

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01148667
Enrollment
40
Registered
2010-06-22
Start date
2007-03-31
Completion date
2008-07-31
Last updated
2010-06-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gut Microbiota, Humoral Immune Responses, Severity of Atopic Dermatitis, Skin Microbiota

Keywords

atopic dermatitis, barrier function, gut, probiotics, skin

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).

Interventions

DIETARY_SUPPLEMENTCasein hydrolysate added with LGG

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.

DIETARY_SUPPLEMENTInfants drink casein hydrolysate without LGG

Infants drink extensively hydrolysed casein formula without added LGG

Sponsors

Academy of Finland
CollaboratorOTHER
Mead Johnson Nutrition
CollaboratorINDUSTRY
Turku University Hospital
Lead SponsorOTHER_GOV

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Caregiver, Investigator)

Eligibility

Sex/Gender
ALL
Age
4 Weeks to 18 Months
Healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

* skin infection or severe infection at the time of enrollment

Design outcomes

Primary

MeasureTime frameDescription
severity of atopic dermatitisMarch 2007 - July 2008Severity of atopic dermatitis of the study infants will be assessed by SCORAD index

Secondary

MeasureTime frameDescription
Maturation of humoral immune responsesMarch 2007 - July 2008Determination of proportions of immunoglobulin secreting cells among peripheral blood mononuclear cells was carried out by ELISPOT assay. The proportions of CD 19+ memory B cells was carried out by flow cytometry

Countries

Finland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 30, 2026