Fecal Microbiota Transplantation for the Treatment of Metabolic Syndrome

NCT ID: NCT02050607

Last Updated: 2020-07-15

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE2
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-01-31
• Study Completion Date: 2020-07-31

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)

Conditions

Metabolic Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Control group

Control group

Group Type: NO_INTERVENTION

No interventions assigned to this group

Fecal microbiota transplantation

Fecal microbiota transplantation from healthy lean donors

Group Type: EXPERIMENTAL

fecal microbiota transplantation from healthy lean donors

Intervention Type: OTHER

fecal microbiota transplantation from healthy lean donors

Interventions

fecal microbiota transplantation from healthy lean donors

fecal microbiota transplantation from healthy lean donors

Intervention Type: OTHER

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

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Catholic University of the Sacred Heart

OTHER

Sponsor Role: lead

Responsible Party

Giovanni Cammarota

Prof

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Catholic University of Sacred Heart - "A. Gemelli" University Hospital

Rome, , Italy

Countries

Italy

Other Identifiers

FMTandMETs-002

Identifier Type: OTHER

Identifier Source: secondary_id

FMTandMETs-001

Identifier Type: -

Identifier Source: org_study_id