Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| vegetarian diet | Experimental | vegetarian diet containing inulin and resistant starch-rich foods, including no meat and fish, but containing eggs and dairy products |
|
| Habitual diet + oral butyrate | Experimental | habitual diet supplemented with 2.4g/day of oral butyrate |
|
| Habitual diet | Active Comparator | habitual diet without supplementation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oral butyrate | Dietary Supplement | Patients follow the habitual diet supplemented with 2.4g/day of oral butyrate |
|
| Measure | Description | Time Frame |
|---|---|---|
| Evaluation of gut microbiota composition | 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] | 0-3 months |
| Complete blood count | composite score | 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 | 0-3 months |
| Glycemic profile | composite score taking into account the levels of : glucose, insulin, glycated hemoglobin (HbA1C), HOMA index | 0-3 months |
| Vitamin profile | composite score, taking into account the levels of: vitamin B12, folic acid, vitamin D | 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 | 0-3 months |
| Kidney function tests |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluation Behçet's symptoms frequency and severity | Participants are asked to complete a questionnaire, which will assess Behçet's symptoms frequency and severity. | 0-3 months |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| AOU Careggi | Florence | 50134 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25852265 | Background | 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. | |
| 25435420 | Background | 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. |
Not provided
Not provided
IPD will not be shared
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D001528 | Behcet Syndrome |
| ID | Term |
|---|---|
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
| D014606 | Uveitis, Anterior |
| D015864 | Panuveitis |
Not provided
Not provided
| ID | Term |
|---|---|
| D002087 | Butyrates |
| D014676 | Diet, Vegetarian |
| ID | Term |
|---|---|
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
| D005232 | Fatty Acids, Volatile |
Not provided
Not provided
Behçet's will be assigned to one of the following treatments:
Not provided
Not provided
Not provided
Not provided
| Vegetarian diet | Dietary Supplement | Patients follow a vegetarian diet containing inulin and resistant starch-rich foods, including no meat and fish, but containing eggs and dairy products |
|
| Habitual diet | Dietary Supplement | Patients follow the habitual diet |
|
composite score taking into account the levels of : serum creatinine, urea, uric acid |
| 0-3 months |
| Mineral profile | composite score taking into account the levels of: sodium, potassium, magnesium, calcium | 0-3 months |
| Iron metabolism | composite score taking into account the levels of: iron, ferritin | 0-3 months |
| Thyroid function | measurement of TSH levels | 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) | 0-3 months |
| Serology for celiac disease | composite score taking into account the levels of: IgA, anti-transglutaminase antibodies (IgA), anti endomysium antibodies (IgA) | 0-3 months |
| Circulating levels of inflammatory cytokines | composite score | 0-3 months |
| Oxidative stress markers | composite score | 0-3 months |
| 24898225 | Background | 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. |
| D014605 |
| Uveitis |
| D014603 | Uveal Diseases |
| D005128 | Eye Diseases |
| D014657 | Vasculitis |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D056660 | Hereditary Autoinflammatory Diseases |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D012873 | Skin Diseases, Genetic |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D017445 | Skin Diseases, Vascular |
| D005227 |
| Fatty Acids |
| D008055 | Lipids |
| D000095500 | Diet, Plant-Based |
| D004035 | Diet Therapy |
| D044623 | Nutrition Therapy |
| D013812 | Therapeutics |
| D004032 | Diet |
| D009747 | Nutritional Physiological Phenomena |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |