Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Effects of the Probiotic Preparation VSL#3 on the Metabolic, Endocrine, Lipidomic and Inflammatory Parameters as Well as Variation of the Microbiota in Pediatric Patients With Body Mass Index >90°
Brief Summary: Obesity in children has become a significant social problem considering that nowadays 4 to 5 % of all children are obese in the industrialized countries with increased incidence in Europe by 10 to 50% over the past 10 years. Obesity is associated with the metabolic syndrome in 30% of the children and is considered as a state of chronic inflammation inducing the production of pro-inflammatory cytokines which determine metabolic and endocrine alterations on the organism. It has been observed that obesity is also linked to a change in the intestinal microflora with a reduction of Bacterioides and bifidobacteria and a decrease of Firmicutes and Staphylococcus aureus. The qualitative and quantitative analysis of the metabolites may provide us with a characterization of the existing phenotypes and variations in relation to the changes of the physiological state, in particular when supplemented or not with a probiotic preparation.


Options:
A: Arm Label: Vit E 200 IU/d; Type: ACTIVE_COMPARATOR; Interventions: Drug: Vitamin E 200 IU/d, Behavioral: Diet and Exercise | Arm Label: Vitamin E 400; Type: ACTIVE_COMPARATOR; Interventions: Drug: Vitamin E 400 IU/d, Behavioral: Diet and Exercise | Arm Label: Vitamin E 800; Type: ACTIVE_COMPARATOR; Interventions: Drug: Vitamin E 800 IU/d, Behavioral: Diet and Exercise | Intervention Type: DRUG; Name: Vitamin E 200 IU/d; Assigned to Arm(s): Vit E 200 IU/d | Intervention Type: DRUG; Name: Vitamin E 400 IU/d; Assigned to Arm(s): Vitamin E 400 | Intervention Type: DRUG; Name: Vitamin E 800 IU/d; Assigned to Arm(s): Vitamin E 800 | Intervention Type: BEHAVIORAL; Name: Diet and Exercise; Assigned to Arm(s): Vit E 200 IU/d, Vitamin E 400, Vitamin E 800
B: Arm Label: Arm 1; Type: PLACEBO_COMPARATOR; Interventions: Drug: pioglitazone-placebo, Drug: Vitamin E-placebo | Arm Label: Arm 2; Type: ACTIVE_COMPARATOR; Interventions: Drug: pioglitazone, Dietary Supplement: Vitamin E | Arm Label: Arm 3; Type: OTHER; Interventions: Drug: pioglitazone-placebo, Dietary Supplement: Vitamin E | Intervention Type: DRUG; Name: pioglitazone-placebo; Assigned to Arm(s): Arm 1 | Intervention Type: DRUG; Name: pioglitazone; Assigned to Arm(s): Arm 2 | Intervention Type: DIETARY_SUPPLEMENT; Name: Vitamin E; Assigned to Arm(s): Arm 2 | Intervention Type: DRUG; Name: pioglitazone-placebo; Assigned to Arm(s): Arm 3 | Intervention Type: DIETARY_SUPPLEMENT; Name: Vitamin E; Assigned to Arm(s): Arm 3 | Intervention Type: DRUG; Name: Vitamin E-placebo; Assigned to Arm(s): Arm 1
C: Arm Label: Polyunsaturated fatty acid (Opti-EPA); Type: ACTIVE_COMPARATOR; Interventions: Drug: Polyunsaturated fatty acid (Opti-EPA) | Arm Label: Placebo; Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo | Intervention Type: DRUG; Name: Polyunsaturated fatty acid (Opti-EPA); Assigned to Arm(s): Polyunsaturated fatty acid (Opti-EPA) | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): Placebo
D: Arm Label: VSL#3 placebo; Type: PLACEBO_COMPARATOR; Interventions: Other: VSL#3 placebo | Arm Label: VSL#3 active probiotic; Type: ACTIVE_COMPARATOR; Interventions: Dietary Supplement: VSL#3 active probiotic | Intervention Type: DIETARY_SUPPLEMENT; Name: VSL#3 active probiotic; Assigned to Arm(s): VSL#3 active probiotic | Intervention Type: OTHER; Name: VSL#3 placebo; Assigned to Arm(s): VSL#3 placebo

Answer: D