Primary Prevention of Atopic Disease by Perinatal Administration of Probiotics
|ClinicalTrials.gov Identifier: NCT00200954|
Recruitment Status : Completed
First Posted : September 20, 2005
Last Update Posted : August 18, 2008
|Condition or disease||Intervention/treatment||Phase|
|Food Allergy Atopic Dermatitis Asthma Rhinitis||Dietary Supplement: Probiotic bacteria Dietary Supplement: Placebo||Not Applicable|
Background. Atopic diseases are increasing in countries with a Western lifestyle. The hygiene hypothesis states that the increase in atopic disease could be due to reduced exposure to microbial antigens in early in life. In search of new preventive therapies for atopic disease, exposure of pregnant women with previous or recent atopic disease, and their offspring to probiotics has been suggested. Probiotics are mono or mixed cultures of microbes which, when applied to animal or man, can beneficially affect the host, among others by inducing an immune response. Probiotics are generally accepted to be safe in children. Probiotics have shown to be effective in primary prevention of atopic disease in high-risk neonates in one study so far. However, it is still unclear by what mechanism probiotics work and which is the most immunopotent (combinations of) probiotic(s). It is likely that antigen-presenting cells (APC's) are involved, since these cells are important in the first line of defence in the gastrointestinal tract. It can be imagined that the immune response is the result of the interplay between probiotics and APC's. In particular, the match between pathogen-associated molecular patterns (PAMP's) on probiotics and their counterparts on APC's, the pathogen-recognition-receptors (PRR's) (like for instance Toll-like receptors) is decisive in this aspect.
Hypothesis. Administration of probiotics to pregnant women and their offspring may reduce the development of sensitization as well as the onset of atopic disease in their offspring.
Aim. To study the effect of probiotics on sensitisation and the prevalence of atopic disease, the severity of atopic disease, the intestinal flora and immune parameters in high-risk newborns.
Methods. To study this hypothesis, a randomised, double-blind placebo-controlled trial will be carried out by administration of probiotics to pregnant women with previous or recent atopic disease as well as to their offspring. Primary outcome parameters are firstly the prevalence and severity of sensitization and atopic disease in the offspring during a follow-up of two years. Secondary outcome parameters are the change in stool composition during treatment with probiotics and in-vitro production of cytokines by PBMCs collected at 3 months, 1 year and 2 years of age.
Expected results. Perinatal administration of probiotics to pregnant women and their offspring may hamper the development of sensitization and atopic disease in their offspring. This may be due to modulation of the intestinal microbiota composition, and modulation of the developing immune system
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||157 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Primary Prevention of Atopic Disease by Perinatal Administration of Probiotics.|
|Study Start Date :||January 2004|
|Actual Primary Completion Date :||December 2007|
|Actual Study Completion Date :||August 2008|
Placebo Comparator: placebo
Dietary Supplement: Placebo
The placebo consists of the carrier of the probiotic bacteria mixture, i.e. rice starch and maltodextran
Active Comparator: 2
Probiotic bacteria group
Dietary Supplement: Probiotic bacteria
3 x 10e9 CFU of a mixture of probiotic bacteria, once daily to the pregnant mothers last 6 weeks of pregnancy.To their offspring during the first year of life.
- Incidence and severity of atopic disease at the age of 2 years. Incidence and prevalence of eczema [ Time Frame: Follow-up at 3 months, 12 months, and 24 months ]
- Serum IgE, stool composition, cytokines produced by PBMNC's [ Time Frame: Follow-up at 3 months, 12 months and 24 months ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00200954
|Wilhelmina Children's Hospital (UMCU)|
|Utrecht, Netherlands, 3508AB|
|Principal Investigator:||Maarten O Hoekstra, MD PhD||Wilhelmina Children's Hospital Utrecht (UMCU)|