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Interventional Bioremediation of Microbiota in Metabolic Syndrome

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2016 by University of Minnesota - Clinical and Translational Science Institute
Sponsor:
Information provided by (Responsible Party):
University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier:
NCT02730962
First received: March 16, 2016
Last updated: June 24, 2016
Last verified: June 2016
  Purpose
The purpose of this study is to determine whether changing the microbial composition in the colon can improve metabolism of sugar in people who are on the verge of developing diabetes (pre-diabetics). Study participants will undergo a fecal microbiota transplantation (FMT) using material from lean donors, as well as a series of tests prior to and after the transplant. The investigators will examine any changes in fecal bacterial composition associated with FMT and determine if any observed changes have an influence on blood sugar metabolism.

Condition Intervention Phase
Pre-Diabetes
Drug: Vancomycin
Other: Placebo
Drug: Neomycin
Drug: Clindamycin
Procedure: Fecal Microbiota Transplantation
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Interventional Bioremediation of Microbiota in Metabolic Syndrome

Resource links provided by NLM:


Further study details as provided by University of Minnesota - Clinical and Translational Science Institute:

Primary Outcome Measures:
  • Insulin sensitivity measured by standard euglycemic insulin clamp. Post-FMT insulin sensitivity measurements between subjects that receive antibiotic versus placebo conditioning will be compared. [ Time Frame: 10 weeks ]

Secondary Outcome Measures:
  • Changes in fecal bacterial composition (pre- vs. post-FMT) associated with antibiotic vs. placebo conditioning, assessed by laboratory analysis. [ Time Frame: Baseline and 10 weeks ]
  • Changes in fecal bacterial composition associated with FMT overall (pooling antibiotic and placebo conditioning groups) by laboratory analysis. [ Time Frame: Baseline and 10 weeks ]
  • Adverse event rates overall and within antibiotic vs. placebo conditioning groups, assessed by review of adverse event diary card, specific questioning, and, as appropriate, examination. [ Time Frame: 10 weeks ]

Estimated Enrollment: 20
Study Start Date: June 2016
Estimated Study Completion Date: June 2019
Estimated Primary Completion Date: June 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Antibiotics prior to FMT
One week prior to FMT, a course of three oral antibiotics are taken: Vancomycin 500mg, Neomycin 1000mg, and Clindamycin 300mg.
Drug: Vancomycin
Vancomycin 3 times a day for 7 days
Drug: Neomycin
Neomycin 3 times a day for 1 day
Drug: Clindamycin
Clindamycin 3 times a day for 5 days
Procedure: Fecal Microbiota Transplantation
FMT conducted via colonoscopy
Placebo Comparator: Placebo prior to FMT
One week prior to FMT, a course of three sugar pills identical to each antibiotic.
Other: Placebo
Placebo pills identical in appearance to each antibiotics to be taken on the same schedule as each antibiotic
Procedure: Fecal Microbiota Transplantation
FMT conducted via colonoscopy

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Provide informed consent
  2. Ambulatory and community dwelling
  3. Age 18 ‐ 70 years of age
  4. Able and willing to comply with the study schedule and procedures
  5. Pre‐diabetic with fasting blood glucose > 100 mg/dL and/or blood glucose 140‐200 mg/dL 2‐hours after ingestion of 75 gm glucose and/or Hemoglobin A1c > 5.7‐6.5 percent

Exclusion Criteria:

  1. Serious, concomitant illness that, in the opinion of the Investigator, would interfere with evaluation of safety or efficacy, or put the subject at risk of harm from study participation.
  2. Known inflammatory bowel disease (Crohn's disease, ulcerative colitis, lymphocytic colitis).
  3. Current abnormal liver tests that may be attributed to a cause other than non-alcoholic liver disease. Note: These exclusionary conditions may include viral hepatitis, alcoholic liver disease, hemochromatosis, Wilson's disease, medication-induced liver test abnormalities, celiac disease.
  4. Renal insufficiency, defined as creatinine ≤ 1.25 mg/dL
  5. Significant alcohol use, defined as > 20 g/day in females and > 30 g/day in males for a period of 3 months within one year prior to screening.
  6. Underlying chronic gastrointestinal disease that can cause diarrhea, including short bowel syndrome, diarrhea-predominant irritable bowel syndrome, malabsorption, celiac disease.
  7. History of partial or complete colectomy.
  8. History of malabsorptive bariatric surgery.
  9. Use of insulin or hypoglycemic medications.
  10. History of anaphylactic food allergies, e.g., peanuts, seafood.
  11. Food intolerances and allergies, including gluten sensitivity, lactose intolerance, and intolerance of high fiber dietary content.
  12. Symptomatic problems associated with intestinal gas and bloating.
  13. Irritable bowel syndrome, including diarrhea-dominant, constipation-dominant, and mixed.
  14. Functional GI disorder.
  15. Unable to tolerate a colonoscopy.
  16. Presence of an indwelling intravenous line.
  17. Infection requiring antibiotics other than the conditioning antibiotics during the study period.
  18. Inability to take vancomycin, neomycin, and clindamycin antibiotics prior to FMT due to known hypersensitivity or intolerance.
  19. Major genetic immune dysfunction (e.g., common variable immune deficiency).
  20. Acquired immune deficiencies due to infections such as HIV.
  21. Immunosuppressive medications including one of the following: systemic corticosteroids, calcineurin inhibitors, thiopurines, methotrexate, biologics (e.g., anti-tumor necrosis factor drugs), cancer chemotherapy.
  22. Planned use of oral probiotics while on study.
  23. Planned or ongoing chemotherapy for malignancy.
  24. Planned antibiotic therapy within the period of the study, e.g., perioperative antibiotics.
  25. Pregnant or lactating. Female participants of child-bearing age and their partners will be counseled on contraceptive measures to prevent pregnancy during the study period.
  26. History of drug or alcohol abuse in the past 2 years.
  27. Currently participating in another clinical study.
  28. Legally incompetent and unable to understand the study's purpose, significance and consequences, and to make decisions accordingly.
  29. Presence of metal implants, such as surgical clips or pacemakers, which will preclude performance of MRI tests.
  30. Inability to undergo MRI testing for any reason, e.g., claustrophobia.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02730962

Contacts
Contact: Alexander Khoruts, MD 612-625-8999 khoru001@umn.edu
Contact: Amanda Kabage, MS 612-624-2956 kabage@umn.edu

Locations
United States, Minnesota
University of Minnesota Medical Center Recruiting
Minneapolis, Minnesota, United States, 55455
Contact: Alexander Khoruts, MD    612-625-8999    khoru001@umn.edu   
Contact: Amanda Kabage, MS    612-624-2956    kabage@umn.edu   
Sponsors and Collaborators
University of Minnesota - Clinical and Translational Science Institute
Investigators
Principal Investigator: Alexander Khoruts, MD University of Minnesota - Clinical and Translational Science Institute
  More Information

Responsible Party: University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier: NCT02730962     History of Changes
Other Study ID Numbers: 1602M84262
Study First Received: March 16, 2016
Last Updated: June 24, 2016
Individual Participant Data  
Plan to Share IPD: No

Additional relevant MeSH terms:
Metabolic Syndrome X
Prediabetic State
Glucose Intolerance
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Diabetes Mellitus
Endocrine System Diseases
Hyperglycemia
Anti-Bacterial Agents
Clindamycin
Clindamycin palmitate
Clindamycin phosphate
Vancomycin
Neomycin
Antibiotics, Antitubercular
Anti-Infective Agents
Antitubercular Agents
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on March 28, 2017