Metabolic SyndromePhase 2NCT02050607
Fecal Microbiota Transplantation for the Treatment of Metabolic Syndrome
A Phase 2 study testing fecal microbiota transplantation from healthy lean donors in people with Metabolic Syndrome, run by Catholic University of the Sacred Heart at 1 site in Italy.
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)… Read more about this study
- Who is it for?
- Ages 30 to 60 years
- Conditions the study is for
- Metabolic Syndrome
- What is being tested?
- fecal microbiota transplantation from healthy lean donors
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteItaly
- Study dates
- Jan 2014to Jul 2020
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Italy1 site
Catholic University of Sacred Heart - "A. Gemelli" University Hospital
Rome, 00168
About this study
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
- Being tested
- fecal microbiota transplantation from healthy lean donors
- Medical subject headings
- Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fecal microbiota transplantation from healthy lean donorsOther
fecal microbiota transplantation from healthy lean donors
| Study group | Role | What they receive |
|---|---|---|
| Control group | No intervention | Control group |
| Fecal microbiota transplantation | Experimental | Fecal microbiota transplantation from healthy lean donors Receives: Other: fecal microbiota transplantation from healthy lean donors |
What is being measured
The primary outcome is the main question the study is designed to answer.
difference in euglycemic clamp value at baseline and after the treatment
Measured: 6 months
Secondary outcomes (10)
Disappearance of metabolic syndrome
Measured: 6 months
Modification in fasting blood glucose
Measured: 6 months
Modification in serum triglycerides
Measured: 6 months
Modification in serum High Density Lipoprotein cholesterol
Measured: 6 months
Modification in blood pressure
Measured: 6 months
Modification in abdominal circumference
Measured: 6 months
Modification in serum Tumor Necrosis Factor-alpha
Measured: 6 months
Modification in serum C-Reactive Protein
Measured: 6 months
Modification in serum interleukin-6
Measured: 6 months
Modification in flow-mediated dilatation (FMD) of the brachial artery
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2014 (estimated)
- Study startJan 2014
- Primary completionJul 2020
- Study completionJul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metabolic SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Catholic University of the Sacred Heart
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Giovanni Cammarota, Catholic University of the Sacred Heart
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02050607
- Sponsor's protocol ID
- FMTandMETs-001
- Other IDs
- FMTandMETs-002
- Status last verified
- Jul 2020
- First submitted
- 7 Nov 2013
- Last updated
- 15 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fecal Microbiota Transplantation for the Treatment of Metabolic Syndrome
- ClinicalTrials.gov ID
- NCT02050607
- Acronym / sponsor ID
- FMTandMETs-001
- Conditions
- Metabolic Syndrome
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Catholic University of the Sacred HeartUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- Jul 2020 (actual)
- Study completion
- Jul 2020 (actual)
- First posted
- 31 Jan 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | No intervention | –Control group |
| Fecal microbiota transplantation | Experimental | Other: fecal microbiota transplantation from healthy lean donorsFecal microbiota transplantation from healthy lean donors |
Who may qualify
- Ages
- 30 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| fecal microbiota transplantation from healthy lean donorsfecal microbiota transplantation from healthy lean donors | Other | Fecal microbiota transplantation |
Primary outcome
difference in euglycemic clamp value at baseline and after the treatment
Time frame: 6 months
10 secondary outcomes
Disappearance of metabolic syndrome
Time frame: 6 months
Modification in fasting blood glucose
Time frame: 6 months
Modification in serum triglycerides
Time frame: 6 months
Modification in serum High Density Lipoprotein cholesterol
Time frame: 6 months
Modification in blood pressure
Time frame: 6 months
Modification in abdominal circumference
Time frame: 6 months
Modification in serum Tumor Necrosis Factor-alpha
Time frame: 6 months
Modification in serum C-Reactive Protein
Time frame: 6 months
Modification in serum interleukin-6
Time frame: 6 months
Modification in flow-mediated dilatation (FMD) of the brachial artery
Time frame: 6 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing fecal microbiota transplantation from healthy lean donors in people with Metabolic Syndrome, run by Catholic University of the Sacred Heart at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 15 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
difference in euglycemic clamp value at baseline and after the treatment (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jul 2020.