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Fecal Microbiota Transplantation for the Treatment of Metabolic Syndrome

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ClinicalTrials.gov Identifier: NCT02050607
Recruitment Status : Unknown
Verified January 2014 by Giovanni Cammarota, Catholic University of the Sacred Heart.
Recruitment status was:  Not yet recruiting
First Posted : January 31, 2014
Last Update Posted : January 31, 2014
Sponsor:
Information provided by (Responsible Party):
Giovanni Cammarota, Catholic University of the Sacred Heart

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)


Condition or disease Intervention/treatment Phase
Metabolic Syndrome Other: fecal microbiota transplantation from healthy lean donors Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 44 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Fecal Microbiota Transplantation for the Treatment of Metabolic Syndrome
Study Start Date : January 2014
Estimated Primary Completion Date : May 2016
Estimated Study Completion Date : August 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
No Intervention: Control group
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




Primary Outcome Measures :
  1. difference in euglycemic clamp value at baseline and after the treatment [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. Disappearance of metabolic syndrome [ Time Frame: 6 months ]
  2. Modification in fasting blood glucose [ Time Frame: 6 months ]
  3. Modification in serum triglycerides [ Time Frame: 6 months ]
  4. Modification in serum High Density Lipoprotein cholesterol [ Time Frame: 6 months ]
  5. Modification in blood pressure [ Time Frame: 6 months ]
  6. Modification in abdominal circumference [ Time Frame: 6 months ]
  7. Modification in serum Tumor Necrosis Factor-alpha [ Time Frame: 6 months ]
  8. Modification in serum C-Reactive Protein [ Time Frame: 6 months ]
  9. Modification in serum interleukin-6 [ Time Frame: 6 months ]
  10. Modification in flow-mediated dilatation (FMD) of the brachial artery [ Time Frame: 6 months ]


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Ages Eligible for Study:   30 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02050607


Contacts
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Contact: Giovanni Cammarota, MD +390630155948 gcammarota@rm.unicatt.it

Locations
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Italy
Catholic University of Sacred Heart - "A. Gemelli" University Hospital Not yet recruiting
Rome, Italy, 00168
Contact: Giovanni Cammarota, MD    +390630155948    gcammarota@rm.unicatt.it   
Principal Investigator: Giovanni Cammarota, MD         
Sub-Investigator: Gianluca Ianiro, MD         
Sub-Investigator: Andrea Giaccari, MD         
Sub-Investigator: Caterina Conte, MD         
Sub-Investigator: Antonio Gasbarrini, MD         
Sponsors and Collaborators
Catholic University of the Sacred Heart

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Responsible Party: Giovanni Cammarota, Prof, Catholic University of the Sacred Heart
ClinicalTrials.gov Identifier: NCT02050607     History of Changes
Other Study ID Numbers: FMTandMETs-001
FMTandMETs-002 ( Other Identifier: Catholic University of Sacred Heart - Rome )
First Posted: January 31, 2014    Key Record Dates
Last Update Posted: January 31, 2014
Last Verified: January 2014

Additional relevant MeSH terms:
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Syndrome
Metabolic Syndrome
Disease
Pathologic Processes
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases