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	Behavior: Probiotic (Lactobacillus rhamnosus GG)

Further Study Details: 

Primary Outcomes: Atopic disease defined as atopic eczema, allergic rhino conjunctivitis or asthma at two years of age
Secondary Outcomes: 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
Expected Total Enrollment:  416

To investigate how probiotics given to pregnant women during the last 4 weeks of pregnancy and the first 4 months after birth influence the establisment 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 developent 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   -   36 Weeks,  Genders Eligible for Study:  Both

Accepts Healthy Volunteers

Criteria

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 beeing 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.

Please refer to this study by ClinicalTrials.gov identifier  NCT00159523

Roar Johnsen, MD, pHD      +47 73597580    roar.johnsen@ntnu.no

Norway
      Dep of Public health and general Practice, Trondheim,  7489,  Norway; Recruiting

Study chairs or principal investigators

Anne Katarina Cartfjord, Director,  Study Director,  Faculty of Medicine, NTNU   

Study ID Numbers:  097-03
Last Updated:  September 11, 2005
Record first received:  September 8, 2005
ClinicalTrials.gov Identifier:  NCT00159523
Health Authority: Norway: Norwegian Social Science Data Services
ClinicalTrials.gov processed this record on 2005-09-13