An interventional study of Oral butyrate and Vegetarian diet in Behcet Syndrome, sponsored by Azienda Ospedaliero-Universitaria Careggi. Completed at 1 site in Italy. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2020-01-28.
Sponsored by Azienda Ospedaliero-Universitaria Careggi · Not applicable, Interventional, and Treatment
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.
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:
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:
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.
Exclusion Criteria:
vegetarian diet containing inulin and resistant starch-rich foods, including no meat and fish, but containing eggs and dairy products
Dietary Supplement: Vegetarian diet
habitual diet supplemented with 2.4g/day of oral butyrate
Dietary Supplement: Oral butyrate
habitual diet without supplementation
Dietary Supplement: Habitual diet
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
Evaluation of gut microbiota composition
Time frame: 0-3 months
Evaluation of butyrate production
For the extraction of SCFAs (and butyrate in particular) the method described in Schnorr et al. will be follow" \[Schnorr SL, Candela M, Rampelli S, Centanni M, Consolandi C, Basaglia G,et al. Gut microbiome of the Hadza hunter-gatherers. Nat Commun 2014;5:3654\]
Time frame: 0-3 months
Complete blood count
composite score
Time frame: 0-3 months
Lipid variables
composite score taking into account the levels of: total cholesterol, low density lipoprotein cholesterol (LDL), high density lipoprotein cholesterol (HDL), triglycerides
Time frame: 0-3 months
Glycemic profile
composite score taking into account the levels of : glucose, insulin, glycated hemoglobin (HbA1C), HOMA index
Time frame: 0-3 months
Vitamin profile
composite score, taking into account the levels of: vitamin B12, folic acid, vitamin D
Time frame: 0-3 months
Liver function tests
composite score taking into account the levels of: aspartate aminotransferase (AST), alanine transaminase (ALT), gammaglutamyl transferase (GGT), alkaline phosphatase (ALP), albumin, prealbumin
Time frame: 0-3 months
Kidney function tests
composite score taking into account the levels of : serum creatinine, urea, uric acid
Time frame: 0-3 months
Mineral profile
composite score taking into account the levels of: sodium, potassium, magnesium, calcium
Time frame: 0-3 months
Iron metabolism
composite score taking into account the levels of: iron, ferritin
Time frame: 0-3 months
Thyroid function
measurement of TSH levels
Time frame: 0-3 months
Inflammatory markers
composite score taking into account the levels of: erythrocyte sedimentation rate (ESR), C-reactive protein (CRP), fibrinogen, serum amyloid A (SAA)
Time frame: 0-3 months
Serology for celiac disease
composite score taking into account the levels of: IgA, anti-transglutaminase antibodies (IgA), anti endomysium antibodies (IgA)
Time frame: 0-3 months
Circulating levels of inflammatory cytokines
composite score
Time frame: 0-3 months
Oxidative stress markers
composite score
Time frame: 0-3 months
Evaluation Behçet's symptoms frequency and severity
Participants are asked to complete a questionnaire, which will assess Behçet's symptoms frequency and severity.
Time frame: 0-3 months
Plan to share: No — IPD will not be shared
This study is completed, as verified in Jan 2020. You cannot join it, but the record below documents what was studied.
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Azienda Ospedaliero-Universitaria Careggi