Fecal Microbiota Transplantation for the Treatment of Met... | NCT02050607

Studies
Fecal Microbiota Transplantation for the Treatment of Metabolic Syndrome

NCT02050607

Sponsor

Catholic University of the Sacred Heart

Status

Withdrawn

Last Update Posted

Jul 15, 2020Actual

Enrollment

0Actual

Phase

Phase 2

Conditions

Metabolic Syndrome

Interventions

fecal microbiota transplantation from healthy lean donors

Countries

Italy

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
FMTandMETs-002	Other Identifier	Catholic University of Sacred Heart - Rome

Status Module

Record Verification Date

Jul 2020

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2014

Primary Completion Date

Jul 2020Actual

Completion Date

Jul 2020Actual

First Submitted Date

Nov 7, 2013

First Submission Date that Met QC Criteria

Jan 29, 2014

First Posted Date

Jan 31, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 13, 2020

Last Update Posted Date

Jul 15, 2020Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Giovanni Cammarota, Prof, Catholic University of the Sacred HeartPrincipal Investigator

Lead Sponsor

Catholic University of the Sacred HeartOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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)

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
fecal microbiota transplantation from healthy lean donors	Other	fecal microbiota transplantation from healthy lean donors	Fecal microbiota transplantation

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
Disappearance of metabolic syndrome		6 months
Modification in fasting blood glucose		6 months
Modification in serum triglycerides

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

30 Years

Maximum Age

60 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Catholic University of Sacred Heart - "A. Gemelli" University Hospital		Rome		00168	Italy

Condition Browse Module

MeSH Terms

ID	Term
D024821	Metabolic Syndrome

Ancestor Terms

ID	Term
D007333	Insulin Resistance
D006946	Hyperinsulinism
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases

Browse Leaves

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Browse Branches

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