Dietary Interventions and Butyrate Production in Behçet's Patients
Condition: Behcet Syndrome
MeSH terms: Behcet Syndrome
Study type: Interventional

Summary: 
      A dietary intervention trial will be performed on patients affected by Behçet's syndrome.
      Three different diets will be compared, analyzing their effects on the gut microbiota
      composition, on endogenous butyrate production and on the general symptoms in Behçet's
      patients.
    

Detailed description: 
      A dietary intervention trial will be conducted with the use of three different diets in order
      to compare the effects of these diets on the gut microbiota composition, on endogenous
      butyrate production and on the general symptoms in Behçet's patients.

      The study will be a randomized, open trial designed to test whether a vegetarian diet or an
      habitual diet supplemented with oral butyrate would benefit the butyrate production, the gut
      microbiota composition and the general symptoms of Behçet's patients, compared with the
      habitual diet.

      The study will involve 30 subjects with Behçet syndrome. Patients will be randomly assigned
      to follow a 3-months isocaloric dietary profile with either:

        -  vegetarian diet containing inulin and resistant starch-rich foods, including no meat and
           fish, but containing eggs and dairy products

        -  habitual diet supplemented with 2.4g/day of oral butyrate

        -  habitual diet without supplementation At the baseline visit, subjects will be educated
           about the aims and methods of the clinical trial and will sign their informed consent
           form.

      Anthropometric measurements, body composition, and blood and stool sampling will be obtained
      from each participant at the beginning and at the end of the intervention period. All
      subjects will be examined between 07.00 and 09.30 hours after a 12 h fasting period.

      The following parameters will be analyzed both at the beginning and at the end of the
      intervention period:

        -  Complete blood count

        -  Lipid variables - total cholesterol, low density lipoprotein cholesterol (LDL), high
           density lipoprotein cholesterol (HDL), triglycerides

        -  Glycemic profile - glucose, insulin, glycated hemoglobin (HbA1C), HOMA index

        -  Liver function tests - aspartate aminotransferase (AST), alanine transaminase (ALT),
           gammaglutamyl transferase (GGT), alkaline phosphatase (ALP), albumin, prealbumin

        -  Kidney function tests - serum creatinine, urea, uric acid

        -  Mineral profile - sodium, potassium, magnesium, calcium

        -  Iron metabolism - iron, ferritin

        -  Vitamin profile - vitamin B12, folic acid, vitamin D

        -  Thyroid function - TSH

        -  Inflammatory markers - erythrocyte sedimentation rate (ESR), C-reactive protein (CRP),
           fibrinogen, serum amyloid A (SAA)

        -  Serology for celiac disease - IgA, anti-transglutaminase antibodies (IgA), anti
           endomysium antibodies (IgA)

        -  Circulating levels of inflammatory cytokines

        -  Oxidative stress markers

        -  Gut microbiota composition

        -  Butyrate production

      At the beginning and at the end of the intervention period, participants will be asked to
      complete a questionnaire, which will assess Behçet's symptoms frequency and severity. In
      addition, participants will be contacted by phone to complete a 24-hours recall in order to
      test the adherence to diets they have been assigned to.
    

Intervention name(s): Oral butyrate; Vegetarian diet; Habitual diet
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): Patients follow the habitual diet supplemented with 2.4g/day of oral butyrate; Patients follow a vegetarian diet containing inulin and resistant starch-rich foods, including no meat and fish, but containing eggs and dairy products; Patients follow the habitual diet
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Behçet's will be assigned to one of the following treatments:
vegetarian diet containing inulin and resistant starch-rich foods, including no meat and fish, but containing eggs and dairy products
habitual diet supplemented with 2.4g/day of oral butyrate
habitual diet without supplementation
Masking: None (Open Label)
Primary purpose: Treatment