GB-EZ-SIM03 Probiotics Study for Childhood Eczema
Condition: Eczema
MeSH terms: Eczema
Study type: Interventional

Summary: 
      Eczema is the most prevalent chronic skin disease in young children, and skin infection is
      commonly seen during eczema flare. Dysbiosis is increasingly recognised in the stool and skin
      of these patients. It is a common practice for parents to start these eczematous children on
      probiotics, but there is limited evidence if this treatment works in young patients. This
      single-centre, open-label clinical trial aims to investigate the benefits of a 3-month
      treatment of young children with eczema with a new probiotics called microbiome baby immunity
      formula (SIM03). Study outcomes include eczema severity, quality of life, biophysical
      measures of the skin and gastrointestinal symptoms, while adverse events related to this
      probiotics treatment will be monitored. The effects of this intervention on stool microbiome
      will also be analysed.
    

Detailed description: 
      Eczema is a common chronic skin disease that affects a substantial part of population. The
      associated economic burden was estimated to cost more than $5 billion per year with the
      rising prevalence of this disease worldwide. A 2016 nation-wide study in China reported that
      12.9% of children (1-7 years) were diagnosed with eczema. Growing evidence has shown that
      atopic dermatitis and/or eczema would increase the risk of several diseases' development,
      including stroke, myocardial infarction, unstable angina, atrial fibrillation, and
      cardiovascular death.

      Except variation of clinical symptoms including dryness and itchy skin in eczema patients,
      gastrointestinal symptoms were also reported by children with atopic eczema, such as
      abdominal pain, abdominal distension, diarrhoea, constipation, vomiting and regurgitation.
      Unique gastrointestinal microflora pattern has also been observed in atopic dermatitis/
      eczema patients when compared with healthy controls: decreased Bifidobacterium and
      Enterococci, especially Bifidobacterium bifidum and Bifidobacterium longum, and increased
      Faecalibacterium have been observed. Therefore, gastrointestinal microflora can serve as the
      disease indicator of eczema.

      The development of gut microbiota starts before birth. The infant's microbiome can impact on
      human health in later life. To prevent disease, we need to nip it in the bud. Emerging
      evidence suggests that gut microbiota modulation can largely affect host immune functions in
      children and adults.

      To date, no baby formula is specific for alleviating eczema-related symptoms for small
      children. GenieBiome Limited, a microbiome research-based company in Hong Kong developed a
      unique oral microbiome formula (baby immunity formula, SIM03) to prevent or treat gut
      dysbiosis and eczema development. SIM03 contains a blend of naturally occurring two
      food-grade probiotics strains, two prebiotics and two postbiotics. The two probiotics belong
      to food-grade Bifidobacterium, which is an important group of probiotic cultures commonly
      used in food products. Especially, research showed that Bifidobacterium could displace the
      proteolytic bacteria causing diarrhoea and recommended the administration of bifidobacteria
      to infants suffering from this symptom. Whereas the two prebiotics belong to food-grade
      oligosaccharides, which have been already used in food products. The two postbiotics belong
      to the acetates, which are also food grade and allowed to add in the foods.

      We hypothesize that the gut microbiota of children with eczema can be modulated to decrease
      the severity of eczema related symptoms and the condition can be improved. A pilot study is
      proposed to assess the effect and safety of SIM03 on eczema severity, gut microbiome and GI
      symptoms of the children with eczema.

      HYPOTHESIS We hypothesize that the microbiome baby immunity formula (SIM03) will lead to the
      improvement of eczema symptoms in children 1-5 years of age.

      OBJECTIVES

        1. To examine the effects of SIM03 in modulating gut microbiota, and improving the eczema
           severity, stool frequency/consistency in children aged 1-5 years old who have eczema;

        2. To evaluate the safety of SIM03 by assessing the parent-reported adverse events in
           children aged 1-5 years old who have eczema in 1-5 years old children.
    

Intervention name(s): Probiotics baby immunity formula (SIM03)
Intervention type(s): Other
Intervention description(s): Daily oral intake of a probiotics sachet
Intervention model: Single Group Assignment
Intervention model description: Single-group, open-label interventional clinical trial
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Eczema; Probiotics; Open-label study; Microbiome; Children