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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00159523
Recruitment Status : Completed
First Posted : September 12, 2005
Last Update Posted : February 5, 2016
Sponsor:
Collaborators:
Tine
St. Olavs Hospital
Information provided by (Responsible Party):
Norwegian University of Science and Technology

Study Description
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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.

Condition or disease Intervention/treatment Phase
Asthma Dermatitis, Atopic Rhinitis, Allergic, Perennial Dietary Supplement: Probiotic Biological: placebo Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 416 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
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
Study Start Date : December 2003
Actual Primary Completion Date : September 2007
Actual Study Completion Date : September 2007

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: probiotic Dietary Supplement: Probiotic
Other Name: Lactobacillus rhamnosus GG
Placebo Comparator: placebo Biological: placebo


Outcome Measures
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Primary Outcome Measures :
  1. Atopic disease defined as atopic eczema, allergic rhino conjunctivitis or asthma at two years of age [ Time Frame: 2 years ]

Secondary Outcome Measures :
  1. Atopic sensitization [ Time Frame: 2 years ]
  2. Positive skin prick test (SPT), elevated total IgE and elevated specific IgE [ Time Frame: 2 years ]
  3. Intestinal microflora [ Time Frame: 2 years ]
  4. Intestinal colonisation with LGG. [ Time Frame: 2 years ]
  5. Oral cavity colonisation with LGG. [ Time Frame: 2 years ]
  6. Immunomarkers [ Time Frame: 2 years ]
  7. TGF in breastmilk [ Time Frame: 2 years ]
  8. Cytokine profile from activated PBMC [ Time Frame: 2 years ]

Eligibility Criteria
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Ages Eligible for Study:   30 Weeks to 36 Weeks   (Child)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00159523


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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Norwegian University of Science and Technology
ClinicalTrials.gov Identifier: NCT00159523    
Other Study ID Numbers: 097-03
First Posted: September 12, 2005    Key Record Dates
Last Update Posted: February 5, 2016
Last Verified: August 2015
Keywords provided by Norwegian University of Science and Technology:
Prevention
Probiotics
Allergy
Hypersensitivity
Additional relevant MeSH terms:
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Rhinitis
Rhinitis, Allergic
Rhinitis, Allergic, Perennial
Dermatitis, Atopic
Dermatitis
Skin Diseases
Respiratory Tract Infections
Infections
Nose Diseases
 Respiratory Tract Diseases
Otorhinolaryngologic Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases, Eczematous