Fecal Microbiota Transplantation for the Treatment of Metabolic Syndrome

Metabolic Syndrome Clinical Trial

Official title:

Fecal Microbiota Transplantation for the Treatment of Metabolic Syndrome

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02050607
• Other study ID #: FMTandMETs-001
• Secondary ID: FMTandMETs-002
• Status: Withdrawn
• Phase: Phase 2
• Start date: January 2014
• Est. completion date: July 2020

Study information

• Verified date: July 2020
• Source: Catholic University of the Sacred Heart
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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)

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: July 2020
• Est. primary completion date: July 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Metabolic Syndrome
• Syndrome

Intervention

Other:
• fecal microbiota transplantation from healthy lean donors
fecal microbiota transplantation from healthy lean donors

Locations

Country	Name	City	State
Italy	Catholic University of Sacred Heart - "A. Gemelli" University Hospital	Rome

Sponsors (1)

Lead Sponsor	Collaborator
Catholic University of the Sacred Heart

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	difference in euglycemic clamp value at baseline and after the treatment		6 months
Secondary	Disappearance of metabolic syndrome		6 months
Secondary	Modification in fasting blood glucose		6 months
Secondary	Modification in serum triglycerides		6 months
Secondary	Modification in serum High Density Lipoprotein cholesterol		6 months
Secondary	Modification in blood pressure		6 months
Secondary	Modification in abdominal circumference		6 months
Secondary	Modification in serum Tumor Necrosis Factor-alpha		6 months
Secondary	Modification in serum C-Reactive Protein		6 months
Secondary	Modification in serum interleukin-6		6 months
Secondary	Modification in flow-mediated dilatation (FMD) of the brachial artery		6 months