Fecal Microbiota Transplantation for the Treatment of Metabolic Syndrome

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 Overview

• Status: Withdrawn
• Conditions: Metabolic Syndrome
• Intervention / Treatment: Other: fecal microbiota transplantation from healthy lean donors

• Study Type: Interventional
• Phase: Phase 2

Contacts and Locations

Study Locations

• Italy
  • Rome, Italy, 00168
    • Catholic University of Sacred Heart - "A. Gemelli" University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 60 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control group
Experimental: Fecal microbiota transplantation; Fecal microbiota transplantation from healthy lean donors	Other: fecal microbiota transplantation from healthy lean donors; fecal microbiota transplantation from healthy lean donors

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Catholic University of the Sacred Heart

Study record dates

Study Major Dates

• Study Start: January 1, 2014
• Primary Completion (Actual): July 1, 2020
• Study Completion (Actual): July 1, 2020

Study Registration Dates

• First Submitted: November 7, 2013
• First Submitted That Met QC Criteria: January 29, 2014
• First Posted (Estimate): January 31, 2014

Study Record Updates

• Last Update Posted (Actual): July 15, 2020
• Last Update Submitted That Met QC Criteria: July 13, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Glucose Metabolism Disorders; Metabolic Diseases; Disease; Insulin Resistance; Hyperinsulinism; Syndrome; Metabolic Syndrome
• Other Study ID Numbers: FMTandMETs-001; FMTandMETs-002 (Other Identifier: Catholic University of Sacred Heart - Rome)