Fecal Microbiota Transplantation for Diabetes Mellitus Type II in Obese Patients
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ClinicalTrials.gov Identifier: NCT02346669 |
Recruitment Status
:
Recruiting
First Posted
: January 27, 2015
Last Update Posted
: June 9, 2016
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Diabetes Mellitus, Type 2 Obesity | Procedure: gastroscopy Drug: Fecal Microbiota Transplantation Other: high fat low fiber diet Other: sham diet Other: low fat high fiber diet | Phase 2 |
Study design:
30 Patients will undergo 2 FMT's from a lean donor and will be randomized into 3 types of diet groups:
- low fat high fiber diet (20% fat)
- no change in fat intake (sham diet)
- high fat low fiber diet (40-45% fat)
The treating physicians and the patients will be blinded for the diet arm. Before and after FMT, patients will be assessed after an overnight fast (and before taking medications) for weight, anthropometric measures, questionnaires (dietary, general health, antibiotic and probiotic exposure, oral diabetes medication quantity, and other drug exposure), blood and stool.
The investigators hypothesize that fecal microbial transplantation from a lean donor to T2DM obese patients, with the combination of low fat high fiber diet, will alter the gut microbiota composition to decrease insulin resistance through microbiota dependent metabolic and immunologic effects.
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 30 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double (Participant, Investigator) |
Primary Purpose: | Treatment |
Official Title: | Fecal Microbiota Transplantation for Diabetes Mellitus Type II in Obese Patients |
Study Start Date : | April 2016 |
Estimated Primary Completion Date : | January 2018 |

Arm | Intervention/treatment |
---|---|
Active Comparator: FMT from a lean donor+ high fat diet
Patients will undergo FMT (Fecal Microboita Transplantation) from a lean donor twice during study through a gastroscopy:
|
Procedure: gastroscopy
as detailed in arm description
Drug: Fecal Microbiota Transplantation
as detailed in arm description
Other: high fat low fiber diet
as detailed in arm description
|
Sham Comparator: FMT from a lean donor+ sham diet
Patients will undergo FMT (Fecal Microboita Transplantation) from a lean donor twice during study through a gastroscopy:
|
Procedure: gastroscopy
as detailed in arm description
Drug: Fecal Microbiota Transplantation
as detailed in arm description
Other: sham diet
as detailed in arm description
|
Active Comparator: FMT from lean donor+ low fat diet
Patients will undergo FMT (Fecal Microboita Transplantation) from a lean donor twice during study through a gastroscopy:
|
Procedure: gastroscopy
as detailed in arm description
Drug: Fecal Microbiota Transplantation
as detailed in arm description
Other: low fat high fiber diet
as detailed in arm description
|
- 30% decrease in insulin resistance [ Time Frame: 6 weeks after first FMT ]Lean donor FMT will result in 30% decrease in insulin resistance that will be further enhanced after a second FMT. These will be meditated by an alteration of intestinal microbiota
- 40% decrease in insulin resistance compared to baseline [ Time Frame: 12 weeks after second FMT ]
- Decreased use of diabetes medications [ Time Frame: Week 6 and 12 post FMT ]
- Improvement in anthropometric measures and in metabolic indices [ Time Frame: week 6 and 12 post FMT ]At least 5% decrease in waist to hip ratio and in total body weight
- Maintenance of an improved insulin resistance [ Time Frame: 28 weeks post FMT ]Insulin resistance at 28 weeks will be in the range (+5% to -5%) of the value achieved at week 12.
- Maintenance of altered of enteric microbiota in the three diet groups [ Time Frame: 6, 12, 28 weeks post FMT ]

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Ages Eligible for Study: | 18 Years to 65 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
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

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): NCT02346669
Contact: Nitsan Maharshak, MD | 972-3-6972488 | nitsanm@tlvmc.gov.il |
Israel | |
Department of Gastroentherology | Recruiting |
Tel Aviv, Israel, 64239 | |
Contact: Nitsan Maharshak, MD 972-3-6972488 nitsanm@tlvmc.gov.il | |
Principal Investigator: Nitsan Maharshak, MD | |
Sub-Investigator: Zamir Halpern, Prof. | |
Sub-Investigator: Nethaniel Cohen, MD | |
Sub-Investigator: Meirav Ben-Yehoyada, PHD | |
Sub-Investigator: Iddo Bar Yishay, MD | |
Sub-Investigator: Ronnie Baruch, B.Sc Nut | |
Sub-Investigator: Eran Segal, Prof. |
Principal Investigator: | Nitsan Maharshak, MD | Tel Aviv Medical Center |
Responsible Party: | Tel-Aviv Sourasky Medical Center |
ClinicalTrials.gov Identifier: | NCT02346669 History of Changes |
Other Study ID Numbers: |
TASMC-14-NM-447-CTIL |
First Posted: | January 27, 2015 Key Record Dates |
Last Update Posted: | June 9, 2016 |
Last Verified: | June 2016 |
Keywords provided by Tel-Aviv Sourasky Medical Center:
Microbiota Diabetes Mellitus, Type 2 Obesity |
Additional relevant MeSH terms:
Diabetes Mellitus Diabetes Mellitus, Type 2 Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases |