Fecal Microbiota Transplantation for Diabetes Mellitus Type II in Obese Patients
Diabetes Mellitus, Type 2, Obesity
About this trial
This is an interventional treatment trial for Diabetes Mellitus, Type 2 focused on measuring Microbiota, Diabetes Mellitus, Type 2, Obesity
Eligibility Criteria
Inclusion Criteria:
- 30≤BMI
A diagnosis of T2DM (≥3 months) and one of the following:
- Fasting glucose level≥126mg/dL and/ or
- A stable dose of anti-diabetic drugs for ≥2 weeks and/or
- HbA1C≥6.5
- Access to a smart phone supporting the research application for tracking food consumption.
Exclusion Criteria:
- participation in other clinical trial
- incapable of signing an informed consent
- pregnancy or breast feeding
- Antibiotic treatment within the prior 3 months or predicted antibiotic treatment
- insulin medications
- drugs or alcohol addiction
- immune mediated diseases
- type 1 diabetes and latent autoimmune diabetes of adults
- systemic disease
- ischemic heart disease
- probiotics consumption
- a new or unstable treatment with anti diabetic medications
Patients will also be excluded if:
- treated by systemic antibiotic during the study
- will not be compliant with the diet
Sites / Locations
- Department of GastroentherologyRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Active Comparator
Sham Comparator
Active Comparator
FMT from a lean donor+ high fat diet
FMT from a lean donor+ sham diet
FMT from lean donor+ low fat diet
Patients will undergo FMT (Fecal Microboita Transplantation) from a lean donor twice during study through a gastroscopy: at time 0 after 6 weeks Patient will start high fat low fiber diet 2 weeks before first FMT and continue on consuming the same diet 9 weeks after the first FMT. Patient will be followed up by a nutritionist through the the study.
Patients will undergo FMT (Fecal Microboita Transplantation) from a lean donor twice during study through a gastroscopy: at time 0 after 6 weeks Patient will start sham diet (no change in fat/fiber consumption) 2 weeks before first FMT and continue on consuming the same diet 9 weeks after the first FMT. Patient will be followed up by a nutritionist through the the study.
Patients will undergo FMT (Fecal Microboita Transplantation) from a lean donor twice during study through a gastroscopy: at time 0 after 6 weeks Patient will start low fat high fiber diet 2 weeks before first FMT and continue on consuming the same diet 9 weeks after the first FMT. Patient will be followed up by a nutritionist through the the study.