Fecal Microbiota Transplantation for the Treatment of Metabolic Syndrome

Study Overview
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Brief Summary
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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)

Official Title
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Fecal Microbiota Transplantation for the Treatment of Metabolic Syndrome

Conditions
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Metabolic Syndrome

Intervention / Treatment
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* Other: fecal microbiota transplantation from healthy lean donors


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Both males and females between 30 and 60 years old BMI>30 and >35 kg/m2 Diagnosis of Metabolic Syndrome according to National Cholesterol Education Program's Adult Treatment Panel III criteria No ongoing therapy for diabetes, hyperlipidemia or arterial hypertension Signature of written informed consent Exclusion Criteria: recent (3 months) use of probiotic, antibiotics or other drugs Increase in triglycerides levels, (≥ 300 mg/dl), LDL levels (≥ 190 mg/dl, or modification of body weight (±5%) during the last 3 months Relevant cardiovascular diseases or kidney diseases Relevant gastrointestinal diseases (such as inflammatory bowel disease or celiac disease) Former gastrointestinal surgery

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control group<br>Control group | |
| Experimental: Fecal microbiota transplantation<br>Fecal microbiota transplantation from healthy lean donors | Other: fecal microbiota transplantation from healthy lean donors<br>* fecal microbiota transplantation from healthy lean donors<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| difference in euglycemic clamp value at baseline and after the treatment |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disappearance of metabolic syndrome |  | 6 months | 
| Modification in fasting blood glucose |  | 6 months | 
| Modification in serum triglycerides |  | 6 months | 
| Modification in serum High Density Lipoprotein cholesterol |  | 6 months | 
| Modification in blood pressure |  | 6 months | 
| Modification in abdominal circumference |  | 6 months | 
| Modification in serum Tumor Necrosis Factor-alpha |  | 6 months | 
| Modification in serum C-Reactive Protein |  | 6 months | 
| Modification in serum interleukin-6 |  | 6 months | 
| Modification in flow-mediated dilatation (FMD) of the brachial artery |  | 6 months |