Fecal Microbiota Transplantation for the Treatment of Metabolic Syndrome

Catholic University of the Sacred Heart

Status and phase

Withdrawn

Phase 2

Conditions

Metabolic Syndrome

Treatments

Other: fecal microbiota transplantation from healthy lean donors

Study type

Interventional

Funder types

Other

Identifiers

NCT02050607

FMTandMETs-002 (Other Identifier)

FMTandMETs-001

Details and patient eligibility

About

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)

Sex

All

Ages

30 to 60 years old

Volunteers

No Healthy Volunteers

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