Effect of POSTbiotics Supplementation on Microbiome in OBese Children: the POST-OB Study
试验速览
- 阶段
- 4 期
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Changes in short chain fatty acids production by gut microbiota
研究概览
简要总结
This study evaluates the possible effect of postbiotics supplementation, combined with interventions aimed at improving diet and lifestyle, on gut microbiota composition and metabolite production. It also wants to determine whether postbiotics supplementation, combined with interventions to improve diet and lifestyle, reduces adverse metabolic consequences together with their co-morbidities.
All participants will follow a behaviour (promotion of physical activity) and dietary treatment according to Italian dietary guidelines for childhood obesity.
Postbiotics and vitamin D3 will be given orally for four months; patients will be evaluated four months after supplementation and diet-lifestyle intervention and four months after the end of supplementation and after the alone diet-lifestyle intervention with blood testing and echosonography of the liver.
详细描述
25-30 Caucasian obese children will be enrolled at the Pediatric Department of San Paolo Hospital - University of Milan.
Stool samples from all enrolled patients at the different time points (t0, before supplementation and diet-lifestyle intervention, t1, four months after supplementation and diet-lifestyle intervention and t2 four months after the end of supplementation and after the alone diet-lifestyle intervention) will be collected and stored at -80°C until the following investigation:
- study of the microbiota biodiversity by high-throughput sequencing techniques (16S rRNA gene sequencing) in order to establish whether postbiotics could modulate the microbial composition in obese children;
- analysis of short chain fatty acids concentration by gas-chromatography (GC-FID) in order to monitor the effect of postbiotics intake modulating microbial metabolite production.
The following tasks will be also performed at t0, t1 and t2:
- Clinical examination including: physical examination, Tanner score evaluation; Bristol Stool Chart
- Blood pressure will be checked in all children by using oscillometric devices validated in the pediatric age group.
- Anthropometry including body circumferences and skinfolds, calculation of BMI z scores and body composition. Body composition will be assessed using an air displacement plethysmography system (BOD POD COSMED-USA).
- Dietary assessment:
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 6 Years 至 14 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •6 <Age <14 years
- •Severe obesity (>3 DS) according to WHO classification.
- •Gestational age: 37-42 weeks.
- •Birth-weight: > 2500 g e < 4000 g
- •Caucasian
排除标准
- •secondary obesity
- •supplementation with pre/probiotics (in the previous 3 months);
- •antibiotic treatment (in the previous 3 months);
- •chronic or acute intestinal diseases (in the previous 3 months).
研究组 & 干预措施
Postbiotic &vitamin D3, lifestyle intervention.
Postbiotics will be given at the dose of 80 mg/day (2 ml per day SMART D3 MATRIX Smartfarma S.r.l. Via San Vittore 40 - 20123 MILAN; immunofos from Lactobacillus paracasei CNCM I-5220). 2 mL of product will give 1600 UI/die of VIT D3. Healthy living habits will be encouraged at t0, t1 and t2 visit.
干预措施: Vitamin D3 (Drug)
Postbiotic &vitamin D3, lifestyle intervention.
Postbiotics will be given at the dose of 80 mg/day (2 ml per day SMART D3 MATRIX Smartfarma S.r.l. Via San Vittore 40 - 20123 MILAN; immunofos from Lactobacillus paracasei CNCM I-5220). 2 mL of product will give 1600 UI/die of VIT D3. Healthy living habits will be encouraged at t0, t1 and t2 visit.
干预措施: Immunofos (Drug)
Postbiotic &vitamin D3, lifestyle intervention.
Postbiotics will be given at the dose of 80 mg/day (2 ml per day SMART D3 MATRIX Smartfarma S.r.l. Via San Vittore 40 - 20123 MILAN; immunofos from Lactobacillus paracasei CNCM I-5220). 2 mL of product will give 1600 UI/die of VIT D3. Healthy living habits will be encouraged at t0, t1 and t2 visit.
干预措施: Promotion of physical activity (Other)
Postbiotic &vitamin D3, lifestyle intervention.
Postbiotics will be given at the dose of 80 mg/day (2 ml per day SMART D3 MATRIX Smartfarma S.r.l. Via San Vittore 40 - 20123 MILAN; immunofos from Lactobacillus paracasei CNCM I-5220). 2 mL of product will give 1600 UI/die of VIT D3. Healthy living habits will be encouraged at t0, t1 and t2 visit.
干预措施: Healthy food habits promotion (Other)
结局指标
主要结局
Changes in short chain fatty acids production by gut microbiota
时间窗: t0: 0 t1: +4 months t2: +8 months
Effect of postbiotics supplementation, combined with interventions aimed at improving diet and lifestyle, will be evaluated. Difference in gut microbiota composition will be evaluated before starting supplementation (t0), at the end of supplementation (t1: +4 months) e after 4 months of dietary dietary-lifestyle intervention without supplementation (t2: +8 months).
Changes in gut microbiota composition
时间窗: t0: 0 t1: +4 months t2: +8 months
Effect of postbiotics supplementation, combined with interventions aimed at improving diet and lifestyle, will be evaluated. Difference in gut microbiota composition will be evaluated before starting supplementation (t0), at the end of supplementation (t1: +4 months) e after 4 months of dietary dietary-lifestyle intervention without supplementation (t2: +8 months).
次要结局
- Changes in LDL-cholesterol levels(t0: 0 t1: +4 months t2: +8 months)
- Changes in HDL-cholesterol levels(t0: 0 t1: +4 months t2: +8 months)
- Changes in body mass index(t0: 0 t1: +4 months t2: +8 months)
- Changes in triglycerides levels(t0: 0 t1: +4 months t2: +8 months)
- Changes in Apoprotein B levels(t0: 0 t1: +4 months t2: +8 months)
- Changes in systemic arterial blood pressure(t0: 0 t1: +4 months t2: +8 months)
- Changes in Bristol stool chart(t0: 0 t1: +4 months t2: +8 months)
- Changes in fasting insulin levels(t0: 0 t1: +4 months t2: +8 months)
- Changes in fasting glucose levels(t0: 0 t1: +4 months t2: +8 months)
- Changes in Apoprotein A1 levels(t0: 0 t1: +4 months t2: +8 months)
- Changes in puberal stage(t0: 0 t1: +4 months t2: +8 months)
- Changes in oral glucose tolerance test results(t0: 0 t1: +4 months t2: +8 months)
- Changes in alanine aminotransferase (ALT) levels(t0: 0 t1: +4 months t2: +8 months)
- Changes in aspartate aminotransferase (AST) levels(t0: 0 t1: +4 months t2: +8 months)
- Changes in Gamma-glutamyl transferase (GGT) levels(t0: 0 t1: +4 months t2: +8 months)
- Changes in complete cell blood count(t0: 0 t1: +4 months t2: +8 months)
- Changes in Homeostasis Model Assessment (HOMA) index(t0: 0 t1: +4 months t2: +8 months)
- Echosonographic changes in liver morphology (degree of steatosis)(t0: 0 t1: +4 months t2: +8 months)
- Changes in total cholesterol levels(t0: 0 t1: +4 months t2: +8 months)
- Changes in Quantitative Insulin-Sensitivity Check Index (QUICKI)(t0: 0 t1: +4 months t2: +8 months)
- Changes in erythrocyte sedimentation rate (ESR)(t0: 0 t1: +4 months t2: +8 months)
- Changes in C-reactive protein (CRP) levels(t0: 0 t1: +4 months t2: +8 months)
- Changes in fecal calprotectin levels(t0: 0 t1: +4 months t2: +8 months)
- Changes in body mass composition assessed with air displacement plethysmography system(t0: 0 t1: +4 months t2: +8 months)
- Changes in body circumference (waist, left arm)(t0: 0 t1: +4 months t2: +8 months)
- Changes in body skinfold thickness (waist, posterior skinfold and anterior skinfold of left arm)(t0: 0 t1: +4 months t2: +8 months)
研究者
Elvira Verduci
Principal Investigator, Paediatrician, University of Milan Researcher
University of Milan