Clinical trial NCT02050607: Fecal Microbiota Transplantation for the Treatment of Metabolic Syndrome
Official title: Fecal Microbiota Transplantation for the Treatment of Metabolic Syndrome
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Metabolic Syndrome
Lead sponsor: Catholic University of the Sacred Heart
Sponsor class: OTHER
First posted: 2014-01-31
Enrollment: 0
Sex: ALL
Minimum age (years): 30
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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)


Eligibility criteria: 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

Primary outcomes:
measure: difference in euglycemic clamp value at baseline and after the treatment
timeFrame: 6 months
Secondary outcomes:
measure: Disappearance of metabolic syndrome
timeFrame: 6 months
measure: Modification in fasting blood glucose
timeFrame: 6 months
measure: Modification in serum triglycerides
timeFrame: 6 months
measure: Modification in serum High Density Lipoprotein cholesterol
timeFrame: 6 months
measure: Modification in blood pressure
timeFrame: 6 months
measure: Modification in abdominal circumference
timeFrame: 6 months
measure: Modification in serum Tumor Necrosis Factor-alpha
timeFrame: 6 months
measure: Modification in serum C-Reactive Protein
timeFrame: 6 months
measure: Modification in serum interleukin-6
timeFrame: 6 months
measure: Modification in flow-mediated dilatation (FMD) of the brachial artery
timeFrame: 6 months
Other outcomes:
Locations:
city: Rome
country: Italy
facility: Catholic University of Sacred Heart - "A. Gemelli" University Hospital
Study officials:
References: