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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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Asthma, Dermatitis, Atopic, Rhinitis, Allergic, Perennial

Intervention / Treatment
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* Dietary Supplement: Probiotic
* Biological: placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 30 Weeks
Maximum Age: 36 Weeks

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: probiotic<br> | Dietary Supplement: Probiotic<br> <br> * Other names: Lactobacillus rhamnosus GG;|
| Placebo Comparator: placebo<br> | Biological: placebo<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Atopic disease defined as atopic eczema, allergic rhino conjunctivitis or asthma at two years of age |  | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Atopic sensitization |  | 2 years | 
| Positive skin prick test (SPT), elevated total IgE and elevated specific IgE |  | 2 years | 
| Intestinal microflora |  | 2 years | 
| Intestinal colonisation with LGG. |  | 2 years | 
| Oral cavity colonisation with LGG. |  | 2 years | 
| Immunomarkers |  | 2 years | 
| TGF in breastmilk |  | 2 years | 
| Cytokine profile from activated PBMC |  | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Prevention, Probiotics, Allergy, Hypersensitivity