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

This study has been completed.
St. Olavs Hospital
Information provided by (Responsible Party):
Norwegian University of Science and Technology Identifier:
First received: September 8, 2005
Last updated: February 4, 2016
Last verified: August 2015
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.

Condition Intervention
Asthma Dermatitis, Atopic Rhinitis, Allergic, Perennial Dietary Supplement: Probiotic Biological: placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: 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

Resource links provided by NLM:

Further study details as provided by Norwegian University of Science and Technology:

Primary Outcome Measures:
  • Atopic disease defined as atopic eczema, allergic rhino conjunctivitis or asthma at two years of age [ Time Frame: 2 years ]

Secondary Outcome Measures:
  • Atopic sensitization [ Time Frame: 2 years ]
  • Positive skin prick test (SPT), elevated total IgE and elevated specific IgE [ Time Frame: 2 years ]
  • Intestinal microflora [ Time Frame: 2 years ]
  • Intestinal colonisation with LGG. [ Time Frame: 2 years ]
  • Oral cavity colonisation with LGG. [ Time Frame: 2 years ]
  • Immunomarkers [ Time Frame: 2 years ]
  • TGF in breastmilk [ Time Frame: 2 years ]
  • Cytokine profile from activated PBMC [ Time Frame: 2 years ]

Enrollment: 416
Study Start Date: December 2003
Study Completion Date: September 2007
Primary Completion Date: September 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: probiotic Dietary Supplement: Probiotic
Other Name: Lactobacillus rhamnosus GG
Placebo Comparator: placebo Biological: placebo

Detailed Description:

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.


Ages Eligible for Study:   30 Weeks to 36 Weeks   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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.
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Please refer to this study by its identifier: NCT00159523

Dep of Public health and general Practice
Trondheim, Norway, 7489
Sponsors and Collaborators
Norwegian University of Science and Technology
St. Olavs Hospital
Study Director: Anne Katarina Cartfjord, Director Faculty of Medicine, NTNU
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Norwegian University of Science and Technology Identifier: NCT00159523     History of Changes
Other Study ID Numbers: 097-03
Study First Received: September 8, 2005
Last Updated: February 4, 2016

Keywords provided by Norwegian University of Science and Technology:

Additional relevant MeSH terms:
Rhinitis, Allergic
Dermatitis, Atopic
Rhinitis, Allergic, Perennial
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Skin Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases, Eczematous processed this record on September 21, 2017