Impact in Off-spring of Mothers After Perinatal Daily Intake of a Probiotic
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|ClinicalTrials.gov Identifier: NCT00159523|
Recruitment Status : Completed
First Posted : September 12, 2005
Last Update Posted : February 5, 2016
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|Condition or disease||Intervention/treatment||Phase|
|Asthma Dermatitis, Atopic Rhinitis, Allergic, Perennial||Dietary Supplement: Probiotic Biological: placebo||Not Applicable|
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 :||Interventional (Clinical Trial)|
|Actual Enrollment :||416 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Outcomes Assessor)|
|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|
Dietary Supplement: Probiotic
Other Name: Lactobacillus rhamnosus GG
|Placebo Comparator: placebo||
- Atopic disease defined as atopic eczema, allergic rhino conjunctivitis or asthma at two years of age [ Time Frame: 2 years ]
- 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 ]
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|Ages Eligible for Study:||30 Weeks to 36 Weeks (Child)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||Yes|
- 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.
- 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.
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
|Dep of Public health and general Practice|
|Trondheim, Norway, 7489|
|Study Director:||Anne Katarina Cartfjord, Director||Faculty of Medicine, NTNU|
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
|Responsible Party:||Norwegian University of Science and Technology|
|Other Study ID Numbers:||
|First Posted:||September 12, 2005 Key Record Dates|
|Last Update Posted:||February 5, 2016|
|Last Verified:||August 2015|
Rhinitis, Allergic, Perennial
Respiratory Tract Infections
Respiratory Tract Diseases
Immune System Diseases
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases, Eczematous