Use of a Novel Diet (UC DIET) for Treatment of Mild to Moderate Active Pediatric Ulcerative Colitis
Condition: Ulcerative Colitis (UC)
MeSH terms: Colitis; Colitis, Ulcerative; Ulcer
Study type: Interventional
Phase: Phase 4

Summary: 
      The goal of the study is to evaluate strategies that target the microbiota for the treatment
      of Ulcerative Colitis , This study will involve a novel diet that the investigators developed
      , based on the hypothesis that UC involves dysbiosis , underutilzation of certain metabolic
      pathways and use of pathways that increase risk of inflammation . The investigators have
      postulated that manipulation of colonic bacterial metabolism with this diet will induce
      remission in UC without involving additional immune suppression.
    

Detailed description: 
      Ulcerative colitis is a chronic inflammatory disease primarily involving the colon. It has
      long been considered to be due to a dysregulated immune response targeting the colon, and
      involves unknown environmental factors . Recent studies have highlighted several
      characteristics which may suggest that UC is associated with alterations of the microbiota,
      defective production of short chain fatty acids and an impaired mucous layer. However at
      present, no effective therapy targets the microbiota or its interaction with the colonic
      epithelium. UC in humans is characterized by increased mucosal sulfides and increased sulfate
      and sulfide reducing bacteria and activation of amino acid metabolism pathways which impair
      butyrate production, whereas certain dietary patterns in humans and rodent models may induce
      dysbiosis and favor sulphide reducing bacteria. Further support for targeting the microbiota
      includes several studies demonstrating that antibiotics might be helpful for severe
      refractory colitis. Development of treatment strategies that target the microbiota could
      reduce exposure to immune suppression, and add new therapeutic strategies that do not exist
      at present.

      Though diet has a significant impact on the composition of the microbiota no dietary
      intervention to date has proven effective for induction of remission. The investigators
      hypothesized that ulcerative colitis is caused by a series of events involving dysbiosis with
      sulfate or sulfide reducing bacteria combined with defective production of short chain fatty
      acids, coupled with a defective mucous layer.
    

Intervention name(s): Ulcerative Colitis Diet; Antibiotic cocktail
Intervention type(s): Other; Drug
Intervention description(s): we have postulated that a diet that we developed that reduces exposure to dietary ingredients that allow sulfide reducing bacteria to thrive, or that impair the mucous layer, coupled with dietary products that enhance butyrate production, could induce remission in UC without involving additional immune suppression.; We have postulating that antibiotic therapy can alter the microbiota clinically. Controlling the microbiota by antibiotics may allow for control of the disease without immune suppression
Other intervention name(s): •Doxycyclin, amoxicillin and metronidazole
Intervention MeSH terms: Anti-Bacterial Agents; Amoxicillin; Metronidazole; Doxycycline
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment