Use of a Selected Mixture of Probiotic Strains for Degrading Gluten During Digestion
Condition: Probiotics
Study type: Interventional

Summary: 
      Gluten intake spreads worldwide, being the major food protein consumed in the Western diets
      (up to 20 g gluten/d). But gluten has unique and unusual features. It resists the complete
      luminal digestion by gastric, pancreatic and intestinal brush border enzymes, and is
      susceptible to post-translational modification (deamidation) by mucosal transglutaminases.
      Apart from partial digestion, gluten per se has a negative impact on a consistent part of the
      worldwide population, which mainly results in the manifestations of celiac disease (CD) or
      other gluten-related disorders. This study will enable to test in vivo a novel multi-species
      probiotic that in vitro has proven to degrade gluten to non-immunotoxic peptides.
    

Detailed description: 
      Hypothesis and Significance:

      The project intends to confirm whether the novel multi-species probiotic preparation has the
      ability to degrade gluten upon digestion at increasing dosages (from 50mg/d up to 10g/d).
      Further we aim to evaluate the efficiency of the probiotic to persist and colonize the human
      gut as well as its ability to modulate the human gut microbiome.

      Since this is a phase 1 trial, healthy participants will be recruited to avoid any triggers
      of CD symptoms. Participants will undergo gluten free diet for 10 days to eliminate any
      traces of gluten from their feces and will be provided probiotic/placebo capsules as long as
      specific amounts of gluten to be ingested with their meal. Faecal samples will be collected
      at the end of each period that increasing gluten amounts were ingested. Residual gluten
      amounts in feces will be evaluated and the fecal microbiome will be studied by 16S
      metabarcoding analysis. Fecal metabolome will be also assessed as long as the persistence and
      colonisation ability of the probiotic preparation by qPCR.

      Specific Aim 1:

      Evaluate the gluten depredating efficiency of the probiotic by ELISA

      Specific Aim 2:

      Investigate the gut microbiome alterations between the intervention groups and possible
      modulation

      Specific Aim 2:

      Investigate the fecal metabolome (Volatiles and short chain fatty acids) between intervention
      groups

      Specific Aim 2:

      Monitor the persistence and colonization ability of the probiotic preparation by qPCR
    

Intervention name(s): Probiotic administration and gluten; Placebo administration and gluten
Intervention type(s): Combination Product; Combination Product
Intervention description(s): Probiotic preparation including multi-species strains of Lactobacillus and Bacillus. The probiotic was administered at baseline and interrupted after 32 days. At the same time the other arm received placebo. Gluten was provided after 10 days of gluten free diet in increasing amounts; The placebo was administered at baseline and interrupted after 32 days. At the same time the other arm received probiotic. Gluten was provided after 10 days of gluten free diet in increasing amounts
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Screening
Keywords: Gluten; Gut microbiome; Celiac disease