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Trial record 1 of 1 for:    NCT02730962
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Interventional Bioremediation of Microbiota in Metabolic Syndrome

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ClinicalTrials.gov Identifier: NCT02730962
Recruitment Status : Terminated (Delays in IND approval caused a lack of funding to conduct the trial.)
First Posted : April 7, 2016
Results First Posted : November 20, 2020
Last Update Posted : February 22, 2023
Information provided by (Responsible Party):
University of Minnesota

Brief Summary:
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 or disease Intervention/treatment Phase
Pre-Diabetes Drug: Vancomycin Other: Placebo Drug: Neomycin Drug: Clindamycin Procedure: Fecal Microbiota Transplantation Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Interventional Bioremediation of Microbiota in Metabolic Syndrome
Study Start Date : June 2016
Actual Primary Completion Date : January 2018
Actual Study Completion Date : January 2018

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Insulin Sensitivity [ Time Frame: 10 weeks ]
    Insulin sensitivity measured by standard euglycemic insulin clamp.

Secondary Outcome Measures :
  1. Microbiome Composition [ Time Frame: 7 days ]
    Outcome is reported as the Shannon alpha diversity index (unitless measure) at baseline and 7 days post FMT.

  2. Changes in Fecal Bacterial Composition Associated With FMT Overall Antibiotic and Placebo Conditioning Groups) by Laboratory Analysis. [ Time Frame: Baseline and 10 weeks ]
    Microbiome composition was assessed post FMT using fecal DNA extraction and sequences. Outcome is reported as the change in relative abundance of the family Ruminococcaceae.

  3. Adverse Event Rates [ Time Frame: 10 weeks ]
    Outcome is reported as a patient self report of adverse events over 10 weeks.

Information from the National Library of Medicine

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

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.

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): NCT02730962

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United States, Minnesota
University of Minnesota Medical Center
Minneapolis, Minnesota, United States, 55455
Sponsors and Collaborators
University of Minnesota
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Principal Investigator: Alexander Khoruts, MD University of Minnesota
  Study Documents (Full-Text)

Documents provided by University of Minnesota:
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Responsible Party: University of Minnesota
ClinicalTrials.gov Identifier: NCT02730962    
Other Study ID Numbers: GI-2015-22791
First Posted: April 7, 2016    Key Record Dates
Results First Posted: November 20, 2020
Last Update Posted: February 22, 2023
Last Verified: February 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Metabolic Syndrome
Prediabetic State
Insulin Resistance
Glucose Metabolism Disorders
Metabolic Diseases
Diabetes Mellitus
Endocrine System Diseases
Clindamycin palmitate
Clindamycin phosphate
Anti-Bacterial Agents
Anti-Infective Agents
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action