Obesity is associated with changes in the composition and metabolic function of the gut microbiota. Fecal microbiota transplantation (FMT), also known as "fecal bacteriotherapy" or "fecal infusion", refers to the process of injecting a liquid suspension of stool from a healthy donor into the gastrointestinal (GI) tract of a patient to cure a specific disease. However, since the recently established concept of human gut microbiome and its significant role in health and disease has caught on in the medical scientific world, this procedure has gained a great pathophysiological strength, meaning not only the simple infusion of stools, but the transplantation of a healthy gut microbiota in a patient with a disrupted one. In a recent dutch experience, FMT from lean donors was able to increase the insulin sensitivity in patients with metabolic syndrome. Our primary aim is to evaluate if FMT from lean healthy donors, in association to lifestyle changes, is able to reduce insulin-resistance more than lifestyle changes alone in patients with metabolic syndrome. All the patients with metabolic syndrome will receive lifestyle counselling (1400 kilocalories diet and physical activity encouragement), than will be randomized to FMT from healthy lean donors by upper endoscopy (group A) or no treatment (group B)
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
fecal microbiota transplantation from healthy lean donors
Catholic University of Sacred Heart - "A. Gemelli" University Hospital
Rome, Italy
difference in euglycemic clamp value at baseline and after the treatment
Time frame: 6 months
Disappearance of metabolic syndrome
Time frame: 6 months
Modification in fasting blood glucose
Time frame: 6 months
Modification in serum triglycerides
Time frame: 6 months
Modification in serum High Density Lipoprotein cholesterol
Time frame: 6 months
Modification in blood pressure
Time frame: 6 months
Modification in abdominal circumference
Time frame: 6 months
Modification in serum Tumor Necrosis Factor-alpha
Time frame: 6 months
Modification in serum C-Reactive Protein
Time frame: 6 months
Modification in serum interleukin-6
Time frame: 6 months
Modification in flow-mediated dilatation (FMD) of the brachial artery
Time frame: 6 months
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