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Lactobacillus Rhamnosus GG: Interaction With Human Microbiota and Immunity

NCT01148667 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2010-06-22

No results posted yet for this study

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).

Conditions

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

Interventions

DIETARY_SUPPLEMENT

Casein 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_SUPPLEMENT

Infants drink casein hydrolysate without LGG

Infants drink extensively hydrolysed casein formula without added LGG

Sponsors & Collaborators

  • Academy of Finland

    collaborator OTHER

  • Mead Johnson Nutrition

    collaborator INDUSTRY

  • Turku University Hospital

    lead OTHER_GOV

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
4 Weeks
Max Age
18 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-03-31
Primary Completion
2008-07-31
Completion
2008-07-31

Countries

  • Finland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01148667 on ClinicalTrials.gov