Clinical trial NCT03274648: Dietary Interventions and Butyrate Production in Behçet's Patients
Official title: Therapeutic Modulation of Butyrate Production in Behçet's Patients: a Dietary Intervention Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Behcet Syndrome
Lead sponsor: Azienda Ospedaliero-Universitaria Careggi
Sponsor class: OTHER
First posted: 2017-09-07
Enrollment: 17
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: Inclusion Criteria:

* All patients affected by Behçet's disease

Exclusion Criteria:

* Pregnancy or breastfeeding
* Presence of diabetes mellitus
* Presence of other immune-mediated diseases
* Presence or history of cancer in the last 5 years
* Presence of infectious diseases in the last 3 months
* No antibiotic therapy in the last 3 months
* No vegetarian or vegan diet
* No intake of pro- or pre-biotics in the last 3 months

Primary outcomes:
measure: Evaluation of gut microbiota composition
timeFrame: 0-3 months
measure: Evaluation of butyrate production
timeFrame: 0-3 months
measure: Complete blood count
timeFrame: 0-3 months
measure: Lipid variables
timeFrame: 0-3 months
measure: Glycemic profile
timeFrame: 0-3 months
measure: Vitamin profile
timeFrame: 0-3 months
measure: Liver function tests
timeFrame: 0-3 months
measure: Kidney function tests
timeFrame: 0-3 months
measure: Mineral profile
timeFrame: 0-3 months
measure: Iron metabolism
timeFrame: 0-3 months
measure: Thyroid function
timeFrame: 0-3 months
measure: Inflammatory markers
timeFrame: 0-3 months
measure: Serology for celiac disease
timeFrame: 0-3 months
measure: Circulating levels of inflammatory cytokines
timeFrame: 0-3 months
measure: Oxidative stress markers
timeFrame: 0-3 months
Secondary outcomes:
measure: Evaluation Behçet's symptoms frequency and severity
timeFrame: 0-3 months
Other outcomes:
Locations:
city: Florence
country: Italy
facility: AOU Careggi
Study officials:
References:
citation: Skef W, Hamilton MJ, Arayssi T. Gastrointestinal Behcet's disease: a review. World J Gastroenterol. 2015 Apr 7;21(13):3801-12. doi: 10.3748/wjg.v21.i13.3801.
citation: Consolandi C, Turroni S, Emmi G, Severgnini M, Fiori J, Peano C, Biagi E, Grassi A, Rampelli S, Silvestri E, Centanni M, Cianchi F, Gotti R, Emmi L, Brigidi P, Bizzaro N, De Bellis G, Prisco D, Candela M, D'Elios MM. Behcet's syndrome patients exhibit specific microbiome signature. Autoimmun Rev. 2015 Apr;14(4):269-76. doi: 10.1016/j.autrev.2014.11.009. Epub 2014 Nov 27.
citation: Wong JM. Gut microbiota and cardiometabolic outcomes: influence of dietary patterns and their associated components. Am J Clin Nutr. 2014 Jul;100 Suppl 1:369S-77S. doi: 10.3945/ajcn.113.071639. Epub 2014 Jun 4.