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OpenTrials
Completed

NCT Number: NCT00159523

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

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Probiotic

Dietary Supplement

Other names: Lactobacillus rhamnosus GG

Placebo

Biological

Primary outcomes

  1. Atopic disease defined as atopic eczema, allergic rhino conjunctivitis or asthma at two years of age

    Time frame: 2 years

Secondary outcomes

  1. Atopic sensitization

    Time frame: 2 years

  2. Positive skin prick test (SPT), elevated total IgE and elevated specific IgE

    Time frame: 2 years

  3. Intestinal microflora

    Time frame: 2 years

  4. Intestinal colonisation with LGG.

    Time frame: 2 years

  5. Oral cavity colonisation with LGG.

    Time frame: 2 years

  6. Immunomarkers

    Time frame: 2 years

  7. TGF in breastmilk

    Time frame: 2 years

  8. Cytokine profile from activated PBMC

    Time frame: 2 years

Sponsors and collaborators

Lead sponsor

Norwegian University of Science and Technology

Other

Collaborators

  • St. Olavs Hospital
  • Tine

Registry information

Official study 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

Important dates

Study start
2003
Primary completion
2007
Study completion
2007
First posted
Sep 12, 2005
Registry last updated
Feb 5, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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