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Fecal Microbiota Transplantation Combined Enteral Nutrition Therapy Contribute to Nutritional Improvement of Patients With Crohns' Disease (NCT02897661)

Patients with Crohns' disease are always complicated with malnutrition. This trial aimed to assess whether FMT accompanied by enteral nutrition (EN) can make contributions to patients with Crohns' disease.
  • Procedure: FMT
    fecal microbiota transplantation (FMT) via mid-GI
    • Drug: Metronidazole
      oral adminstration
      • Methyl-5-nitroimidazole-1-ethanol
    • : EN
      via nasal feeding tube
      Ages eligible for Study
      18 Years to 65 Years
      Genders eligible for Study
      All
      Accepts Healthy Volunteers
      No
      Inclusion Criteria:
      • patients aged from 18 to 65, regardless of gender;
      • moderate to severe active CD patients(CDAI>220),accompanied with malnutrition;
      • infection status;
      • patients with high compliance;
      • suitable for fecal microbiota transplantation and enteral nutrition therapy;
      • history of safe mesalazine use.
      Exclusion Criteria:
      • severe infection which affected vital signs;
      • parenteral infection such as urinary tract, lung and so on;
      • mycobacterium tuberculosis infection;
      • immunosuppressor or biologicals use within 6 week;
      • allergic to metronidazole,salicylic acid preparation, etc;
      • complicated with perianal Crohn's disease, intestinal fistula, intestinal obstruction;
      • accompanied by any severe disease such as cancer or AIDS;
      • patients who are in pregnant or going to pregnant;
      • patients who has disability mentally and physically.

      1 locations

      China (1)
      • Medical Center for Digestive Diseases, The Second Affiliated Hospital of Nanjing Medical University
        recruiting
        Nanjing, Jiangsu, China, 210011
      Status:
      recruiting
      Type:
      Interventional
      Phase:
      Ⅱ, Ⅲ
      Start:
      31 July, 2016
      Updated:
      25 January, 2017
      Participants:
      60
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