Primary Prevention of Atopic Disease by Perinatal Administration of Probiotics
Condition: Food Allergy; Atopic Dermatitis; Asthma; Rhinitis
MeSH terms: Rhinitis; Dermatitis; Food Hypersensitivity
Study type: Interventional

Summary: 
      Administration of probiotics to pregnant women from an atopic family and subsequently to
      their high-risk newborns results in prevention of the incidence or in a decrease of the
      severity of atopic disease during infancy.
    

Detailed description: 
      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
    

Intervention name(s): Probiotic bacteria; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): 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.; The placebo consists of the carrier of the probiotic bacteria mixture, i.e. rice starch and maltodextran
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: prospective; intervention; randomised; probiotics; atopy