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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 : Completed
First Posted : April 7, 2016
Last Update Posted : October 22, 2018
Sponsor:
Information provided by (Responsible Party):
University of Minnesota

Tracking Information
First Submitted Date  ICMJE March 16, 2016
First Posted Date  ICMJE April 7, 2016
Last Update Posted Date October 22, 2018
Study Start Date  ICMJE June 2016
Actual Primary Completion Date January 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 1, 2016)
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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 24, 2016)
  • 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 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: April 1, 2016)
  • Changes in fecal bacterial composition (pre- vs. post-FMT) associated with antibiotic vs. placebo conditioning, assessed by laboratory analysis. [ Time Frame: 10 weeks ]
  • Changes in fecal bacterial composition associated with FMT overall (pooling antibiotic and placebo conditioning groups) by laboratory analysis. [ Time Frame: 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 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Interventional Bioremediation of Microbiota in Metabolic Syndrome
Official Title  ICMJE Interventional Bioremediation of Microbiota in Metabolic Syndrome
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Pre-Diabetes
Intervention  ICMJE
  • Drug: Vancomycin
    Vancomycin 3 times a day for 7 days
  • Other: Placebo
    Placebo pills identical in appearance to each antibiotics to be taken on the same schedule as each antibiotic
  • 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
Study Arms  ICMJE
  • 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.
    Interventions:
    • Drug: Vancomycin
    • Drug: Neomycin
    • Drug: Clindamycin
    • Procedure: Fecal Microbiota Transplantation
  • Placebo Comparator: Placebo prior to FMT
    One week prior to FMT, a course of three sugar pills identical to each antibiotic.
    Interventions:
    • Other: Placebo
    • Procedure: Fecal Microbiota Transplantation
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 19, 2018)
12
Original Estimated Enrollment  ICMJE
 (submitted: April 1, 2016)
20
Actual Study Completion Date  ICMJE January 2018
Actual Primary Completion Date January 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02730962
Other Study ID Numbers  ICMJE 1602M84262
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party University of Minnesota
Study Sponsor  ICMJE University of Minnesota
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Alexander Khoruts, MD University of Minnesota
PRS Account University of Minnesota
Verification Date October 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP