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

Not Applicable

Completed

• Conditions: Rhinitis, Allergic, Perennial; Asthma; Dermatitis, Atopic
• Interventions: Dietary Supplement: Probiotic; Biological: placebo

• Registration Number: NCT00159523
• Lead Sponsor: Norwegian University of Science and Technology

Brief Summary

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

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.

Study Timeline

• Study Start: 2003-12
• Study First Submitted: 2005-09-08
• Study First Submitted QC: 2005-09-08
• Study First Posted: 2005-09-12
• Primary Completion: 2007-09
• Study Completion: 2007-09
• Status Verified: 2015-08
• Last Update Submitted: 2016-02-04
• Last Update Posted: 2016-02-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 416

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
probiotic	Probiotic	-
placebo	placebo	-

Primary Outcome Measures

Name	Time	Method
Atopic disease defined as atopic eczema, allergic rhino conjunctivitis or asthma at two years of age	2 years

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Dep of Public health and general Practice; 🇳🇴 Trondheim, Norway