Effectiveness of PENTABIOCEL in Clinical and Laboratory Recovery of Children With Celiac Disease
Condition: Celiac Disease
MeSH terms: Celiac Disease
Study type: Interventional

Summary: 
      Celiac disease (CD) is an inflammatory condition of the small intestine. Environmental and
      genetic factors are involved in the development of CD. Apart from environmental and genetic
      factors other factors may also be involved, such as alteration in intestinal microbiota.
      Probiotic supplementation has been shown to be able to determine the intestinal healing.
      Recently the use of a mixture of some specific bacterial strains has shown its effectiveness.
      In this study effectiveness of a probiotic "Pentabiocel" which is a mixture of five different
      bacterial strains will be evaluated in CD affected children (already on a gluten-free diet)
      through a double-blind randomised placebo control trial.
    

Detailed description: 
      Celiac disease (CD) is an intestinal inflammatory condition characterized by permanent
      intolerance to gluten, a protein complex present in wheat, barley, and rye, in genetically
      predisposed subjects. In the early phase of the disease, specific autoantibodies are
      generally present, which is relevant for diagnostic purposes (especially anti-tissue
      transglutaminase antibodies (anti TTG) of IgA (immunoglobulin A) class and anti-endomysial
      antibodies( EMA), and a duodenal and jejunal mucosal lesion that is characterized by an
      increase in intraepithelial lymphocytes (IEL), hypertrophy of crypts and villous atrophy. The
      only accepted and effective treatment for CD so far is a lifelong strict gluten-free
      diet(GFD).

      On the clinical level, CD can have an extremely variable expression, from almost silent forms
      to cases with more or less striking intestinal and extra-intestinal manifestations. Treatment
      with a strict GFD causes gradual normalisation of the intestinal lesion (generally within
      12-24 months). The persistence of a minimal intestinal lesion and of mostly gastro-enteric
      symptoms, is not rare in adulthood, especially for the difficulty of maintaining a "zero
      gluten content" diet over time. The "timing" of recovery induced by the GFD is variable from
      patient to patient and depends on numerous factors such as presentation mode (typical,
      atypical or silent), the age of onset, adherence to a strict GFD, etc. Among the factors that
      may condition the normalisation of the clinical picture. According to some recent data, the
      quantitative and qualitative typology of the intestinal microbiome may have role. Prospective
      studies in healthy infants who are at risk of developing CD have shown that the Human
      Leukocyte Antigen (HLA) genotype, together with other environmental factors, influences the
      composition of the microbiota. In addition, celiac patients have alterations of the
      intestinal microbiome (dysbiosis) that do not completely normalize even after starting GFD.
      It has therefore been suggested that CD may favor dysbiosis which in turn negatively
      influences intestinal mucosal damage and can promote inflammation through the expansion of
      harmful bacteria and the reduction of beneficial bacteria.

      Probiotics are live microorganisms, that when ingested in appropriate quantities, give to the
      host benefits. Some probiotics may digest gluten and are thus able to reduce their toxicity
      when used in fermentation processes. For example, a research group (Di Cagno et al.) has
      shown that bakery products made using a natural yeast with wheat flour fermented by proteases
      of lactobacilli and mushrooms, can be taken with confidence by celiac patients. This data
      suggests that the simple administration of a probiotic is capable to provide benefit in
      patients with CD leading to an improvement also of intestinal symptoms. However, it is clear
      from the literature that not all probiotic strains possess this characteristic. It has been
      shown that a mixture of probiotic strains, in particular belonging to the species
      Lactobacillus paracasei, Lactobacillus plantarum, Bifidobacterium breve, and Bifidobacterium
      animalis subsp lactis, is able to significantly improve the irritable colon-like
      gastrointestinal symptoms of patients with CD. Pentabiocel is the trade name of the product
      containing the above mentioned probiotic mixture: Lactobacillus paracasei (LMG P-17504),
      Lactobacillus plantarum (CECT 4528), Bifidobacterium breve Bbr8 (LMG P-17501),
      Bifidobacterium breve (BL10 LMG P-17500) and Bifidobacterium animalis subsp lactis Bi1 (LMG P
      -17,502).

      In this randomized double blind placebo controlled trial study investigators will investigate
      the effect of "Pentabiocel" on children already on GFD.

      The aim of this study is to evaluate the efficacy of "Pentabiocel" in the clinical and
      laboratory recovery of children with celiac disease
    

Intervention name(s): Pentabiocel; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Pentabiocel is the trade name of the product containing the probiotic mixture of: Lactobacillus paracasei LMG P-17504, Lactobacillus plantarum CECT 4528, Bifidobacterium breve Bbr8 LMG P-17501, Bifidobacterium breve BL10 LMG P-17500 and Bifidobacterium animalis subsp lactis Bi1 LMG P -17,502.; Placebo is composed of maltodextrin which is easily digestible, being absorbed as rapidly as glucose. Maltodextrin listed by the U.S. Food and Drug Administration (FDA) as a safe food additive.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Gluten; Probiotic; Microbiota; Dysbiosis