- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02730962
Interventional Bioremediation of Microbiota in Metabolic Syndrome
February 20, 2023 updated by: University of Minnesota
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.
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
12
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Minnesota
-
Minneapolis, Minnesota, United States, 55455
- University of Minnesota Medical Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Provide informed consent
- Ambulatory and community dwelling
- Age 18 - 70 years of age
- Able and willing to comply with the study schedule and procedures
- 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:
- 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.
- Known inflammatory bowel disease (Crohn's disease, ulcerative colitis, lymphocytic colitis).
- 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.
- Renal insufficiency, defined as creatinine ≤ 1.25 mg/dL
- 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.
- Underlying chronic gastrointestinal disease that can cause diarrhea, including short bowel syndrome, diarrhea-predominant irritable bowel syndrome, malabsorption, celiac disease.
- History of partial or complete colectomy.
- History of malabsorptive bariatric surgery.
- Use of insulin or hypoglycemic medications.
- History of anaphylactic food allergies, e.g., peanuts, seafood.
- Food intolerances and allergies, including gluten sensitivity, lactose intolerance, and intolerance of high fiber dietary content.
- Symptomatic problems associated with intestinal gas and bloating.
- Irritable bowel syndrome, including diarrhea-dominant, constipation-dominant, and mixed.
- Functional GI disorder.
- Unable to tolerate a colonoscopy.
- Presence of an indwelling intravenous line.
- Infection requiring antibiotics other than the conditioning antibiotics during the study period.
- Inability to take vancomycin, neomycin, and clindamycin antibiotics prior to FMT due to known hypersensitivity or intolerance.
- Major genetic immune dysfunction (e.g., common variable immune deficiency).
- Acquired immune deficiencies due to infections such as HIV.
- Immunosuppressive medications including one of the following: systemic corticosteroids, calcineurin inhibitors, thiopurines, methotrexate, biologics (e.g., anti-tumor necrosis factor drugs), cancer chemotherapy.
- Planned use of oral probiotics while on study.
- Planned or ongoing chemotherapy for malignancy.
- Planned antibiotic therapy within the period of the study, e.g., perioperative antibiotics.
- 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.
- History of drug or alcohol abuse in the past 2 years.
- Currently participating in another clinical study.
- Legally incompetent and unable to understand the study's purpose, significance and consequences, and to make decisions accordingly.
- Presence of metal implants, such as surgical clips or pacemakers, which will preclude performance of MRI tests.
- Inability to undergo MRI testing for any reason, e.g., claustrophobia.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / 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.
|
Vancomycin 3 times a day for 7 days
Neomycin 3 times a day for 1 day
Clindamycin 3 times a day for 5 days
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.
|
FMT conducted via colonoscopy
Placebo pills identical in appearance to each antibiotics to be taken on the same schedule as each antibiotic
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Insulin Sensitivity
Time Frame: 10 weeks
|
Insulin sensitivity measured by standard euglycemic insulin clamp.
|
10 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Microbiome Composition
Time Frame: 7 days
|
Outcome is reported as the Shannon alpha diversity index (unitless measure) at baseline and 7 days post FMT.
|
7 days
|
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.
|
Baseline and 10 weeks
|
Adverse Event Rates
Time Frame: 10 weeks
|
Outcome is reported as a patient self report of adverse events over 10 weeks.
|
10 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2016
Primary Completion (Actual)
January 1, 2018
Study Completion (Actual)
January 1, 2018
Study Registration Dates
First Submitted
March 16, 2016
First Submitted That Met QC Criteria
April 1, 2016
First Posted (Estimate)
April 7, 2016
Study Record Updates
Last Update Posted (Estimate)
February 22, 2023
Last Update Submitted That Met QC Criteria
February 20, 2023
Last Verified
February 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Glucose Metabolism Disorders
- Metabolic Diseases
- Endocrine System Diseases
- Diabetes Mellitus
- Insulin Resistance
- Hyperinsulinism
- Metabolic Syndrome
- Prediabetic State
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Enzyme Inhibitors
- Anti-Bacterial Agents
- Protein Synthesis Inhibitors
- Vancomycin
- Clindamycin
- Clindamycin palmitate
- Clindamycin phosphate
- Neomycin
Other Study ID Numbers
- GI-2015-22791
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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