Fecal Microbiota Transplantation for the Treatment of Metabolic Syndrome

NCT02050607 | Withdrawn Phase 2

• 2 other identifiers: FMTandMETs-001FMTandMETs-002
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• difference in euglycemic clamp value at baseline and after the treatment

  6 months

Secondary Outcomes (10)

• 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

Study Arms (2)

Control group

NO INTERVENTION

Control group

Fecal microbiota transplantation

EXPERIMENTAL

Fecal microbiota transplantation from healthy lean donors

Other: fecal microbiota transplantation from healthy lean donors

Interventions

fecal microbiota transplantation from healthy lean donors OTHER

fecal microbiota transplantation from healthy lean donors

Fecal microbiota transplantation

Eligibility Criteria

• Age: 30 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Catholic University of the Sacred Heart: lead

Study Sites (1)

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

Rome, 00168, Italy

Location

MeSH Terms

Conditions

Metabolic Syndrome

Condition Hierarchy (Ancestors)

Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof

Study Record Dates

• First Submitted: November 7, 2013
• First Posted: January 31, 2014
• Study Start: January 1, 2014
• Primary Completion: July 1, 2020
• Study Completion: July 1, 2020
• Last Updated: July 15, 2020

Record last verified: 2020-07

Locations

IT (1)