Prebiotic as a Supplement of Gluten-free Diet in the Management of Celiac Disease in Children
Condition: Celiac Disease
MeSH terms: Celiac Disease
Study type: Interventional

Summary: 
      Prebiotics are known as substances affecting beneficially the organism by restoring the
      intestinal microbiota balance, stabilizing the intestinal barrier and modulating the
      endocrine and immune functions. In many persons suffering from celiac disease (CD), despite a
      gluten-free diet (GFD), an impaired intestinal barrier functionality, accompanied by altered
      intestinal microbiota and ongoing intestinal inflammation is observed. For these reasons,
      prebiotic could be a promising and low-risk adjuvant in the dietetic management of CD. It was
      hypothesize that prebiotic preparation Synergy 1 consumed by CD children as a supplement of a
      GFD will affect beneficial the intestinal permeability and intestinal microbiota without side
      effects.
    

Detailed description: 
      Prebiotics, including inulin-type fructans (ITFs) are a group of the naturally occurring
      plant carbohydrates stored in various amounts in tubers, bulbs and tuberous roots of several
      edible fruits and vegetables and in particularly large amounts in the tubers of Helianthus
      tuberosus (Jerusalem artichoke) and Cichorium intybus (chicory). Because of their unique
      structural properties, they are not hydrolyzed by the enzymes of the upper intestinal
      digestive tract and reach the colon unchanged, therefore are classified as prebiotics.
      Prebiotics are defined as selectively fermented ingredients that allow specific changes in
      the composition and/or balance of the microbiota. ITFs, particularly the mixture of short-
      and long-chain polymers, indicate several beneficial effects, including the positive changes
      in the histological picture of the intestine (proliferation in the crypts and Goblet cells,
      longer intestinal villi) and modulation of the endocrine and immune functions. Moreover, they
      have a great potential as agents improving or maintaining a balanced intestinal microbiota
      both in the lumen and at the mucosal surface, to one in which bifidobacteria and lactobacilli
      come to greater prominence. This, so-called healthier flora, should provide increased
      resistance to gut infections and may also have immuno-modulatory properties. Until now,
      inulin and fructooligosaccharide (FOS) have been tested mainly in animal models of
      inflammatory bowel diseases (IBD). Reports on animal colitis model suggests that prebiotics
      have the anti-inflammatory properties as they reduce the inflammation symptoms, along with
      the increase in bifidobacteria or lactobacilli number, and in some reports, the increase in
      the concentration of butyrate in the gut.

      Prebiotics are known as substances affecting beneficially the organism by restoring the
      intestinal microbiota balance, stabilizing the intestinal barrier and modulating the
      endocrine and immune functions. In many persons suffering from celiac disease (CD), despite a
      gluten-free diet (GFD), an impaired intestinal barrier functionality, accompanied by altered
      intestinal microbiota and ongoing intestinal inflammation is observed. For these reasons,
      prebiotics could be a promising and low-risk adjuvant in the dietetic management of CD. It
      was hypothesized that Synergy 1 consumed by CD children as a supplement of a GFD will affect
      beneficial the intestinal permeability and intestinal microbiota without side effects. The
      primary objective of this randomized placebo-controlled study was to determine the effect of
      3-months consumption of Synergy 1 versus placebo, as the supplements of a GFD, on the
      intestinal permeability in CD children, in particular on the concentration of the intestinal
      fatty acid binding protein (iFABP) as a biomarker of intestinal permeability. The secondary
      objective was to determine the effect of Synergy 1 versus placebo applied in GFD on the
      changes in the gut microbiota quantity and metabolism in CD children.
    

Intervention name(s): Synergy 1; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): a daily dose: 7 g/day of Synergy1 (oligofructose enriched inulin) consumed for 12 weeks together with a strict gluten-free diet; a daily dose: 7 g/day of placebo (maltodextrin) consumed for 12 weeks together with a strict gluten-free diet
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: prebiotic; pediatric patients; health status; intestine permeability