Therapeutic Modulation of Butyrate Production in Behçet's Patients: a Dietary Intervention Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 17
- 试验地点
- 1
- 主要终点
- Oxidative stress markers
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All patients affected by Behçet's disease
排除标准
- •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
研究组 & 干预措施
Habitual diet + oral butyrate
habitual diet supplemented with 2.4g/day of oral butyrate
干预措施: Oral butyrate (Dietary Supplement)
vegetarian diet
vegetarian diet containing inulin and resistant starch-rich foods, including no meat and fish, but containing eggs and dairy products
干预措施: Vegetarian diet (Dietary Supplement)
Habitual diet
habitual diet without supplementation
干预措施: Habitual diet (Dietary Supplement)
结局指标
主要结局
Oxidative stress markers
时间窗: 0-3 months
composite score
Circulating levels of inflammatory cytokines
时间窗: 0-3 months
composite score
Evaluation of butyrate production
时间窗: 0-3 months
For the extraction of SCFAs (and butyrate in particular) the method described in Schnorr et al. will be follow" \[Schnorr SL, Candela M, Rampelli S, Centanni M, Consolandi C, Basaglia G,et al. Gut microbiome of the Hadza hunter-gatherers. Nat Commun 2014;5:3654\]
Lipid variables
时间窗: 0-3 months
composite score taking into account the levels of: total cholesterol, low density lipoprotein cholesterol (LDL), high density lipoprotein cholesterol (HDL), triglycerides
Glycemic profile
时间窗: 0-3 months
composite score taking into account the levels of : glucose, insulin, glycated hemoglobin (HbA1C), HOMA index
Evaluation of gut microbiota composition
时间窗: 0-3 months
Complete blood count
时间窗: 0-3 months
composite score
Iron metabolism
时间窗: 0-3 months
composite score taking into account the levels of: iron, ferritin
Thyroid function
时间窗: 0-3 months
measurement of TSH levels
Inflammatory markers
时间窗: 0-3 months
composite score taking into account the levels of: erythrocyte sedimentation rate (ESR), C-reactive protein (CRP), fibrinogen, serum amyloid A (SAA)
Vitamin profile
时间窗: 0-3 months
composite score, taking into account the levels of: vitamin B12, folic acid, vitamin D
Serology for celiac disease
时间窗: 0-3 months
composite score taking into account the levels of: IgA, anti-transglutaminase antibodies (IgA), anti endomysium antibodies (IgA)
Liver function tests
时间窗: 0-3 months
composite score taking into account the levels of: aspartate aminotransferase (AST), alanine transaminase (ALT), gammaglutamyl transferase (GGT), alkaline phosphatase (ALP), albumin, prealbumin
Kidney function tests
时间窗: 0-3 months
composite score taking into account the levels of : serum creatinine, urea, uric acid
Mineral profile
时间窗: 0-3 months
composite score taking into account the levels of: sodium, potassium, magnesium, calcium
次要结局
- Evaluation Behçet's symptoms frequency and severity(0-3 months)
研究者
GIACOMO EMMI
Principal Investigator
Azienda Ospedaliero-Universitaria Careggi