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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

Tracking Information
First Submitted Date  ICMJE September 8, 2005
First Posted Date  ICMJE September 12, 2005
Last Update Posted Date February 5, 2016
Study Start Date  ICMJE December 2003
Actual Primary Completion Date September 2007   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 18, 2012)
Atopic disease defined as atopic eczema, allergic rhino conjunctivitis or asthma at two years of age [ Time Frame: 2 years ]
Original Primary Outcome Measures  ICMJE
 (submitted: September 8, 2005)
Atopic disease defined as atopic eczema, allergic rhino conjunctivitis or asthma at two years of age
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 18, 2012)
  • Atopic sensitization [ Time Frame: 2 years ]
  • Positive skin prick test (SPT), elevated total IgE and elevated specific IgE [ Time Frame: 2 years ]
  • Intestinal microflora [ Time Frame: 2 years ]
  • Intestinal colonisation with LGG. [ Time Frame: 2 years ]
  • Oral cavity colonisation with LGG. [ Time Frame: 2 years ]
  • Immunomarkers [ Time Frame: 2 years ]
  • TGF in breastmilk [ Time Frame: 2 years ]
  • Cytokine profile from activated PBMC [ Time Frame: 2 years ]
Original Secondary Outcome Measures  ICMJE
 (submitted: September 8, 2005)
  • Atopic senstization
  • Positive skin prick test (SPT), elevated total IgE and elevated spesific IgE
  • Intestinal microflora
  • Intestinal colonisation with LGG.
  • Oral cavity colonisation with LGG.
  • Immunmarkers
  • TGF in breastmilk
  • Cytokine profile from activated PBMC
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Impact in Off-spring of Mothers After Perinatal Daily Intake of a Probiotic
Official Title  ICMJE 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
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE
  • Asthma
  • Dermatitis, Atopic
  • Rhinitis, Allergic, Perennial
Intervention  ICMJE
  • Dietary Supplement: Probiotic
    Other Name: Lactobacillus rhamnosus GG
  • Biological: placebo
Study Arms  ICMJE
  • Experimental: probiotic
    Intervention: Dietary Supplement: Probiotic
  • Placebo Comparator: placebo
    Intervention: Biological: placebo
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 8, 2005)
416
Original Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE September 2007
Actual Primary Completion Date September 2007   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 30 Weeks to 36 Weeks   (Child)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Norway
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00159523
Other Study ID Numbers  ICMJE 097-03
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Norwegian University of Science and Technology
Study Sponsor  ICMJE Norwegian University of Science and Technology
Collaborators  ICMJE
  • Tine
  • St. Olavs Hospital
Investigators  ICMJE
Study Director: Anne Katarina Cartfjord, Director Faculty of Medicine, NTNU
PRS Account Norwegian University of Science and Technology
Verification Date August 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP