Lactobacillus Rhamnosus GG: Interaction With Human Microbiota and Immunity

Phase 4

Completed

• Conditions: Gut Microbiota; Skin Microbiota; Humoral Immune Responses; Severity of Atopic Dermatitis
• Interventions: Dietary Supplement: Casein hydrolysate added with LGG; Dietary Supplement: Infants drink casein hydrolysate without LGG

• Registration Number: NCT01148667
• Lead Sponsor: Turku University Hospital

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2007-03
• Primary Completion: 2008-07
• Study Completion: 2008-07
• Status Verified: 2010-06
• Study First Submitted: 2010-06-21
• Study First Submitted QC: 2010-06-21
• Last Update Submitted: 2010-06-21
• Study First Posted: 2010-06-22
• Last Update Posted: 2010-06-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

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

Exclusion Criteria

• skin infection or severe infection at the time of enrollment

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Infants drink formula added with LGG	Casein hydrolysate added with LGG	Infants have been randomized (1:1) to get casein hydrolysate with or without LGG
Infants drink casein hydrolysate without LGG	Infants drink casein hydrolysate without LGG	Infants get extensively hydrolysed casein formula

Primary Outcome Measures

Name	Time	Method
severity of atopic dermatitis	March 2007 - July 2008	Severity of atopic dermatitis of the study infants will be assessed by SCORAD index

Secondary Outcome Measures

Name	Time	Method
Maturation of humoral immune responses	March 2007 - July 2008	Determination 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

Trial Locations

Locations (1)

Turku University Central Hospital; 🇫🇮 Turku, Finland