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Fecal Microbiota Transplantation for Diabetes Mellitus Type II in Obese Patients

This study is currently recruiting participants.
Verified June 2016 by Tel-Aviv Sourasky Medical Center
Sponsor:
ClinicalTrials.gov Identifier:
NCT02346669
First Posted: January 27, 2015
Last Update Posted: June 9, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Tel-Aviv Sourasky Medical Center
  Purpose
The incidence of obesity has dramatically increased during the last three decades, leading to a significant increase of obesity-related morbidity, including type 2 diabetes mellitus (T2DM) that is characterized by resistance of target tissues to insulin action. T2DM obese patients may be treated by medications or by bariatric surgery. Both alternatives have limitations due to incomplete resolution of the diseases, high cost or potential procedural related morbidity. An increasing body of evidence points to a role of the enteric microbiota in the pathogenesis of obesity-related insulin resistance. In addition to that, the gut microbiota is directly affected by the diet composition. Studies in T2DM mice carrying human gut germs, demonstrated special interactions between the gut microbiota and the host, creating a typical microbiota composition which changes significantly following diet change from a western diet, rich with sugar, to a vegetarian diet rich with fibers. This rapid alternations in the microbiota composition has also shown in humans, after changing from western to high fiber diet. A change in diet life style may lead to an improvement in T2DM symptoms such as decrease in visceral adipose tissue.

Condition Intervention 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 Type: Interventional
Study Design: 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

Resource links provided by NLM:

MedlinePlus related topics: Bowel Movement
U.S. FDA Resources

Further study details as provided by Tel-Aviv Sourasky Medical Center:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]
Estimated Enrollment: 30
Study Start Date: April 2016
Estimated Primary Completion Date: January 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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:

  1. at time 0
  2. 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.
 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:

  1. at time 0
  2. 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.
 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:

  1. at time 0
  2. 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.
 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

Detailed Description:

Study design:

30 Patients will undergo 2 FMT's from a lean donor and will be randomized into 3 types of diet groups:

  1. low fat high fiber diet (20% fat)
  2. no change in fat intake (sham diet)
  3. 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.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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

Inclusion Criteria:

  • 30≤BMI

  • A diagnosis of T2DM (≥3 months) and one of the following:

    1. Fasting glucose level≥126mg/dL and/ or
    2. A stable dose of anti-diabetic drugs for ≥2 weeks and/or
    3. 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
  Contacts and Locations
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): NCT02346669


Contacts
Contact: Nitsan Maharshak, MD 972-3-6972488 nitsanm@tlvmc.gov.il

Locations
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.         
Sponsors and Collaborators
Tel-Aviv Sourasky Medical Center
Investigators
Principal Investigator: Nitsan Maharshak, MD Tel Aviv Medical Center
  More Information

Responsible Party: Tel-Aviv Sourasky Medical Center
ClinicalTrials.gov Identifier: NCT02346669     History of Changes
Other Study ID Numbers: TASMC-14-NM-447-CTIL
First Submitted: January 8, 2015
First Posted: January 27, 2015
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


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