Fecal Microbiota Transplantation for the Treatment of Metabolic Syndrome
Primary Purpose
Metabolic Syndrome
Status
Withdrawn
Phase
Phase 2
Locations
Italy
Study Type
Interventional
Intervention
fecal microbiota transplantation from healthy lean donors
Sponsored by
About this trial
This is an interventional treatment trial for Metabolic Syndrome
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
Sites / Locations
- Catholic University of Sacred Heart - "A. Gemelli" University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Control group
Fecal microbiota transplantation
Arm Description
Control group
Fecal microbiota transplantation from healthy lean donors
Outcomes
Primary Outcome Measures
difference in euglycemic clamp value at baseline and after the treatment
Secondary Outcome Measures
Disappearance of metabolic syndrome
Modification in fasting blood glucose
Modification in serum triglycerides
Modification in serum High Density Lipoprotein cholesterol
Modification in blood pressure
Modification in abdominal circumference
Modification in serum Tumor Necrosis Factor-alpha
Modification in serum C-Reactive Protein
Modification in serum interleukin-6
Modification in flow-mediated dilatation (FMD) of the brachial artery
Full Information
NCT ID
NCT02050607
First Posted
November 7, 2013
Last Updated
July 13, 2020
Sponsor
Catholic University of the Sacred Heart
1. Study Identification
Unique Protocol Identification Number
NCT02050607
Brief Title
Fecal Microbiota Transplantation for the Treatment of Metabolic Syndrome
Official Title
Fecal Microbiota Transplantation for the Treatment of Metabolic Syndrome
Study Type
Interventional
2. Study Status
Record Verification Date
July 2020
Overall Recruitment Status
Withdrawn
Study Start Date
January 2014 (undefined)
Primary Completion Date
July 2020 (Actual)
Study Completion Date
July 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Catholic University of the Sacred Heart
4. Oversight
Data Monitoring Committee
No
5. Study Description
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)
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metabolic Syndrome
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control group
Arm Type
No Intervention
Arm Description
Control group
Arm Title
Fecal microbiota transplantation
Arm Type
Experimental
Arm Description
Fecal microbiota transplantation from healthy lean donors
Intervention Type
Other
Intervention Name(s)
fecal microbiota transplantation from healthy lean donors
Intervention Description
fecal microbiota transplantation from healthy lean donors
Primary Outcome Measure Information:
Title
difference in euglycemic clamp value at baseline and after the treatment
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Disappearance of metabolic syndrome
Time Frame
6 months
Title
Modification in fasting blood glucose
Time Frame
6 months
Title
Modification in serum triglycerides
Time Frame
6 months
Title
Modification in serum High Density Lipoprotein cholesterol
Time Frame
6 months
Title
Modification in blood pressure
Time Frame
6 months
Title
Modification in abdominal circumference
Time Frame
6 months
Title
Modification in serum Tumor Necrosis Factor-alpha
Time Frame
6 months
Title
Modification in serum C-Reactive Protein
Time Frame
6 months
Title
Modification in serum interleukin-6
Time Frame
6 months
Title
Modification in flow-mediated dilatation (FMD) of the brachial artery
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Catholic University of Sacred Heart - "A. Gemelli" University Hospital
City
Rome
ZIP/Postal Code
00168
Country
Italy
12. IPD Sharing Statement
Learn more about this trial
Fecal Microbiota Transplantation for the Treatment of Metabolic Syndrome
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