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Impact in Off-spring of Mothers After Perinatal Daily Intake of a Probiotic

This study has been completed.
Sponsor:
Collaborators:
TINE Dairies AB
St. Olavs Hospital
Information provided by (Responsible Party):
Norwegian University of Science and Technology
ClinicalTrials.gov Identifier:
NCT00159523
First received: September 8, 2005
Last updated: September 18, 2012
Last verified: September 2012
History of Changes

September 8, 2005
September 18, 2012
December 2003
Not Provided
Atopic disease defined as atopic eczema, allergic rhino conjunctivitis or asthma at two years of age [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Atopic disease defined as atopic eczema, allergic rhino conjunctivitis or asthma at two years of age
Complete list of historical versions of study NCT00159523 on ClinicalTrials.gov Archive Site
  • Atopic sensitization [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Positive skin prick test (SPT), elevated total IgE and elevated specific IgE [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Intestinal microflora [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Intestinal colonisation with LGG. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Oral cavity colonisation with LGG. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Immunomarkers [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • TGF in breastmilk [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Cytokine profile from activated PBMC [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Atopic senstization
  • Positive skin prick test (SPT), elevated total IgE and elevated spesific IgE
  • Intestinal microflora
  • Intestinal colonisation with LGG.
  • Oral cavity colonisation with LGG.
  • Immunmarkers
  • TGF in breastmilk
  • Cytokine profile from activated PBMC
Not Provided
Not Provided
 
Impact in Off-spring of Mothers After Perinatal Daily Intake of a Probiotic
The Impact of Perinatal Daily Supplement of a Probiotic (Lactobacillus Rhamnosus GG), Given to Mothers, on Immunological Development, Atopic Sensitisation and Allergic Disease in Their Off-spring

A probiotic (Lactobacillus rhamnosus GG) supplement to pregnant women the last four weeks of pregnancy and three months after birth is expected to give a 40% reduction in risk of atopic sensitisation and allergic disease at two years of age, compared to placebo.

To investigate how probiotics given to pregnant women during the last 4 weeks of pregnancy and the first 4 months after birth influence the establishment and composition of the gut microflora in children from birth until two years of age.

At the same time to investigate the relationship between gut flora composition and the development of the immune system.

To investigate the relationship between supplement of probiotics to pregnant and breast-feeding women, the microbial composition of the gut flora in their children, the development of the childrens' immune system, and the prevalence of atopic sensitisation and atopic disease at two years of age.
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Prevention
  • Asthma
  • Dermatitis, Atopic
  • Rhinitis, Allergic, Perennial
  • Dietary Supplement: Probiotic
    Other Name: Lactobacillus rhamnosus GG
  • Biological: placebo
  • Experimental: probiotic
    Intervention: Dietary Supplement: Probiotic
  • Placebo Comparator: placebo
    Intervention: Biological: placebo
Dotterud CK, Storrø O, Johnsen R, Oien T. Probiotics in pregnant women to prevent allergic disease: a randomized, double-blind trial. Br J Dermatol. 2010 Sep;163(3):616-23. Epub 2010 Jun 9.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
416
September 2007
Not Provided

Inclusion Criteria:

  • All pregnant women understanding Norwegian language and who has signed an informed consent form, can be included.
  • Inclusion must take place before week 36 in the pregnancy.
  • The woman must plan to breast-feed the first 4 months after birth.
  • She must live in Trondheim.

Exclusion Criteria:

  • Not being able to fill in the questionnaire in Norwegian language
  • Lactose intolerance
  • Consumption of probiotics earlier in the pregnancy.
  • Intention to move from Trondheim in the next 25 months.
  • Pregnant women in risk of eclampsia, or other serious disease that can influence beast-feeding or care for the child.
Both
30 Weeks to 36 Weeks
Yes
Contact information is only displayed when the study is recruiting subjects
Norway
 
NCT00159523
097-03
No
Norwegian University of Science and Technology
Norwegian University of Science and Technology
  • TINE Dairies AB
  • St. Olavs Hospital
Study Director: Anne Katarina Cartfjord, Director Faculty of Medicine, NTNU
Norwegian University of Science and Technology
September 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP