Pre-DiabetesPhase 2NCT02730962
Interventional Bioremediation of Microbiota in Metabolic Syndrome
A Phase 2 study testing Vancomycin, Neomycin and Clindamycin in people with Pre-Diabetes, run by University of Minnesota at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Pre-Diabetes
- What is being tested?
- Vancomycin, Neomycin and Clindamycin
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2016to Jan 2018
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Minnesota Medical Center
Minneapolis, Minnesota, 55455
About this study
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.
- Conditions
- Pre-Diabetes
- Being tested
- Vancomycin, Placebo, Neomycin, Clindamycin, Fecal Microbiota Transplantation
- Medical subject headings
- Glucose Intolerance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VancomycinDrug
Vancomycin 3 times a day for 7 days
PlaceboOther
Placebo pills identical in appearance to each antibiotics to be taken on the same schedule as each antibiotic
NeomycinDrug
Neomycin 3 times a day for 1 day
ClindamycinDrug
Clindamycin 3 times a day for 5 days
Fecal Microbiota TransplantationProcedure or surgery
FMT conducted via colonoscopy
| Study group | Role | What they receive |
|---|---|---|
| Antibiotics prior to FMT | Experimental | One week prior to FMT, a course of three oral antibiotics are taken: Vancomycin 500mg, Neomycin 1000mg, and Clindamycin 300mg. Receives: Drug: Vancomycin; Drug: Neomycin; Drug: Clindamycin; Procedure: Fecal Microbiota Transplantation |
| Placebo prior to FMT | Placebo comparator | One week prior to FMT, a course of three sugar pills identical to each antibiotic. Receives: Other: Placebo; Procedure: Fecal Microbiota Transplantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Insulin Sensitivity
Insulin sensitivity measured by standard euglycemic insulin clamp.
Measured: 10 weeks
Secondary outcomes (3)
Microbiome Composition
Outcome is reported as the Shannon alpha diversity index (unitless measure) at baseline and 7 days post FMT.
Measured: 7 days
Changes in Fecal Bacterial Composition Associated With FMT Overall Antibiotic and Placebo Conditioning Groups) by Laboratory Analysis.
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.
Measured: Baseline and 10 weeks
Adverse Event Rates
Outcome is reported as a patient self report of adverse events over 10 weeks.
Measured: 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2016 (estimated)
- Study startJun 2016
- Primary completionJan 2018
- Study completionJan 2018
Why it stopped: Delays in IND approval caused a lack of funding to conduct the trial.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Pre-DiabetesStudies of the same condition, open and under way.
- More trials run by University of MinnesotaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alexander Khoruts, MD, Principal investigator, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02730962
- Sponsor's protocol ID
- GI-2015-22791
- Status last verified
- Feb 2023
- First submitted
- 16 Mar 2016
- Last updated
- 22 Feb 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interventional Bioremediation of Microbiota in Metabolic Syndrome
- ClinicalTrials.gov ID
- NCT02730962
- Acronym / sponsor ID
- GI-2015-22791
- Conditions
- Pre-Diabetes
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Delays in IND approval caused a lack of funding to conduct the trial.
- Enrolment
- 12 participants (actual)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Study start
- Jun 2016
- Primary completion
- Jan 2018 (actual)
- Study completion
- Jan 2018 (actual)
- First posted
- 7 Apr 2016 (estimated)
- Results
- Posted 20 Nov 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Antibiotics prior to FMT | Experimental | Drug: Vancomycin, Drug: Neomycin, Drug: Clindamycin, Procedure: Fecal Microbiota TransplantationOne week prior to FMT, a course of three oral antibiotics are taken: Vancomycin 500mg, Neomycin 1000mg, and Clindamycin 300mg. |
| Placebo prior to FMT | Placebo comparator | Other: Placebo, Procedure: Fecal Microbiota TransplantationOne week prior to FMT, a course of three sugar pills identical to each antibiotic. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (30 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VancomycinVancomycin 3 times a day for 7 days | Drug | Antibiotics prior to FMT |
| PlaceboPlacebo pills identical in appearance to each antibiotics to be taken on the same schedule as each antibiotic | Other | Placebo prior to FMT |
| NeomycinNeomycin 3 times a day for 1 day | Drug | Antibiotics prior to FMT |
| ClindamycinClindamycin 3 times a day for 5 days | Drug | Antibiotics prior to FMT |
| Fecal Microbiota TransplantationFMT conducted via colonoscopy | Procedure or surgery | Antibiotics prior to FMT, Placebo prior to FMT |
Primary outcome
Insulin Sensitivity
Time frame: 10 weeks
Insulin sensitivity measured by standard euglycemic insulin clamp.
3 secondary outcomes
Microbiome Composition
Time frame: 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
Adverse Event Rates
Time frame: 10 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Feb 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alexander Khoruts, MD principal investigator
University of Minnesota
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Vancomycin, Neomycin and Clindamycin in people with Pre-Diabetes, run by University of Minnesota at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 30 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 22 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 20 Nov 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Insulin Sensitivity (time frame: 10 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Feb 2023.