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

This study has been completed.
Sponsor:
Collaborators:
TINE Dairies AB
St. Olavs Hospital
Information provided by (Responsible Party):
Norwegian University of Science and Technology
ClinicalTrials.gov Identifier:
NCT00159523
First received: September 8, 2005
Last updated: September 18, 2012
Last verified: September 2012
  Purpose

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
Dietary Supplement: Probiotic
Biological: placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Prevention
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

Resource links provided by NLM:


Further study details as provided by Norwegian University of Science and Technology:

Primary Outcome Measures:
  • Atopic disease defined as atopic eczema, allergic rhino conjunctivitis or asthma at two years of age [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Atopic sensitization [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Positive skin prick test (SPT), elevated total IgE and elevated specific IgE [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Intestinal microflora [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Intestinal colonisation with LGG. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Oral cavity colonisation with LGG. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Immunomarkers [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • TGF in breastmilk [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Cytokine profile from activated PBMC [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Enrollment: 416
Study Start Date: December 2003
Study Completion Date: September 2007
Arms Assigned Interventions
Experimental: probiotic Dietary Supplement: Probiotic
Other Name: Lactobacillus rhamnosus GG
Placebo Comparator: placebo Biological: 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.

  Eligibility

Ages Eligible for Study:   30 Weeks to 36 Weeks
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00159523

Locations
Norway
Dep of Public health and general Practice
Trondheim, Norway, 7489
Sponsors and Collaborators
Norwegian University of Science and Technology
TINE Dairies AB
St. Olavs Hospital
Investigators
Study Director: Anne Katarina Cartfjord, Director Faculty of Medicine, NTNU
  More Information

Publications:
Responsible Party: Norwegian University of Science and Technology
ClinicalTrials.gov Identifier: NCT00159523     History of Changes
Other Study ID Numbers: 097-03
Study First Received: September 8, 2005
Last Updated: September 18, 2012
Health Authority: Norway: Norwegian Social Science Data Services

Keywords provided by Norwegian University of Science and Technology:
Prevention
Probiotics
Allergy
Hypersensitivity

Additional relevant MeSH terms:
Asthma
Dermatitis
Dermatitis, Atopic
Rhinitis
Rhinitis, Allergic, Perennial
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Skin Diseases
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases, Eczematous
Nose Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases

ClinicalTrials.gov processed this record on August 28, 2014