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

Asthma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00159523
• Other study ID #: 097-03
• Status: Completed
• Phase: N/A
• First received: September 8, 2005
• Last updated: February 4, 2016
• Start date: December 2003
• Est. completion date: September 2007

Study information

• Verified date: August 2015
• Source: Norwegian University of Science and Technology
• Contact: n/a
• Is FDA regulated: No
• Health authority: Norway: Norwegian Social Science Data Services
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 416
• Est. completion date: September 2007
• Est. primary completion date: September 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 30 Weeks to 36 Weeks

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Asthma
• Dermatitis, Atopic
• Rhinitis, Allergic, Perennial

Intervention

Dietary Supplement:
• Probiotic

Biological:
• placebo

Locations

Country	Name	City	State
Norway	Dep of Public health and general Practice	Trondheim

Sponsors (3)

Lead Sponsor	Collaborator
Norwegian University of Science and Technology	St. Olavs Hospital, Tine

Country where clinical trial is conducted

Norway, 

References & Publications (2)

Dotterud CK, Storrø O, Johnsen R, Oien T. Probiotics in pregnant women to prevent allergic disease: a randomized, double-blind trial. Br J Dermatol. 2010 Sep;163(3):616-23. doi: 10.1111/j.1365-2133.2010.09889.x. Epub 2010 Jun 9. — View Citation

Simpson MR, Dotterud CK, Storrø O, Johnsen R, Øien T. Perinatal probiotic supplementation in the prevention of allergy related disease: 6 year follow up of a randomised controlled trial. BMC Dermatol. 2015 Aug 1;15:13. doi: 10.1186/s12895-015-0030-1. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Atopic disease defined as atopic eczema, allergic rhino conjunctivitis or asthma at two years of age		2 years	No
Secondary	Atopic sensitization		2 years	No
Secondary	Positive skin prick test (SPT), elevated total IgE and elevated specific IgE		2 years	No
Secondary	Intestinal microflora		2 years	No
Secondary	Intestinal colonisation with LGG.		2 years	No
Secondary	Oral cavity colonisation with LGG.		2 years	No
Secondary	Immunomarkers		2 years	No
Secondary	TGF in breastmilk		2 years	No
Secondary	Cytokine profile from activated PBMC		2 years	No