TerminatedNCT02730962Updated Feb 22, 2023Results posted

Interventional Bioremediation of Microbiota in Metabolic Syndrome

A Phase 2 interventional study of Vancomycin and Placebo in Pre-Diabetes, sponsored by University of Minnesota. Terminated at 1 site in United States. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2023-02-22.

Sponsored by University of Minnesota · Phase 2, Interventional, and Treatment

Why this study was terminated

Delays in IND approval caused a lack of funding to conduct the trial.

Phase: Phase 2
Study type: Interventional
Enrollment: 12
Allocation: Randomized
Ages: 18 Years to 70 Years
Sex: All

Study 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.

Conditions studied

Pre-Diabetes

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In context

Metabolic Syndrome

1,964 studies on the registry are indexed under Metabolic Syndrome; 330 are open to participants now.

This study's enrollment of 12 is below the median of 60 across 1,460 interventional studies indexed under Metabolic Syndrome.

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Lead sponsor

University of Minnesota is the lead sponsor of 1,184 studies on the registry; 195 are open to participants now.

Of its 132 completed or terminated interventional studies of FDA-regulated products, 91 (69%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 70 Years
Sexes eligible: All
Accepts healthy volunteers: No

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

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 design

Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Double (Participant, Investigator)
Enrollment: 12 participants (actual)

Study arms

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 · 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.
Other: Placebo · Procedure: Fecal Microbiota Transplantation

Interventions

DrugVancomycin
Vancomycin 3 times a day for 7 days
OtherPlacebo
Placebo pills identical in appearance to each antibiotics to be taken on the same schedule as each antibiotic
DrugNeomycin
Neomycin 3 times a day for 1 day
DrugClindamycin
Clindamycin 3 times a day for 5 days
ProcedureFecal Microbiota Transplantation
FMT conducted via colonoscopy

What researchers measure

Primary outcomes

Insulin Sensitivity
Insulin sensitivity measured by standard euglycemic insulin clamp.
Time frame: 10 weeks

Secondary outcomes

Microbiome Composition
Outcome is reported as the Shannon alpha diversity index (unitless measure) at baseline and 7 days post FMT.
Time frame: 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.
Time frame: Baseline and 10 weeks
Adverse Event Rates
Outcome is reported as a patient self report of adverse events over 10 weeks.
Time frame: 10 weeks

Results

Posted Nov 20, 2020

Participant flow

Participant flow — Overall Study
Milestone	Antibiotics Prior to FMT	Placebo Prior to FMT
Started	7	5
Completed	7	5
Not completed	0	0

Outcome measures

PrimaryInsulin Sensitivity

Insulin sensitivity measured by standard euglycemic insulin clamp.

Time frame:: 10 weeks

No measurements were reported for this outcome.

SecondaryMicrobiome Composition

Outcome is reported as the Shannon alpha diversity index (unitless measure) at baseline and 7 days post FMT.

Time frame:: 7 days
Reported as:: Mean · unitless measure

Microbiome Composition
unitless measure	Antibiotics Prior to FMT	Placebo Prior to FMT
Baseline	3.3 ± 0.5	3.3 ± 0.5
7 days post FMT	3.3 ± 0.5	1.2 ± 0.2

SecondaryChanges 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.

Time frame:: Baseline and 10 weeks
Reported as:: Mean · percent relative abundance

Changes in Fecal Bacterial Composition Associated With FMT Overall Antibiotic and Placebo Conditioning Groups) by Laboratory Analysis.
percent relative abundance	Antibiotics Prior to FMT	Placebo Prior to FMT
Changes in Fecal Bacterial Composition Associated With FMT Overall Antibiotic and Placebo Conditioning Groups) by Laboratory Analysis.	5 ± 2	17 ± 1

SecondaryAdverse Event Rates

Outcome is reported as a patient self report of adverse events over 10 weeks.

Time frame:: 10 weeks
Reported as:: Number · Number of adverse events

Adverse Event Rates
Number of adverse events	Antibiotics Prior to FMT	Placebo Prior to FMT
Adverse Event Rates	6	4

Adverse events

Collected over Adverse events were collected at each study visit during study participation, which was approximately 3-4 months, and collected again at a 6 month follow up visit after study completion.. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Antibiotics Prior to FMT	0/7 (0%)	1/7 (14.3%)	6/7 (85.7%)
Placebo Prior to FMT	0/5 (0%)	0/5 (0%)	4/5 (80%)

Most frequent serious events

Most frequent serious events
Event	Antibiotics Prior to FMT	Placebo Prior to FMT
Clostridium Difficile InfectionGastrointestinal disorders	1/7	0/5

Most frequent other events

Showing 10 of 14

Most frequent other events
Event	Antibiotics Prior to FMT	Placebo Prior to FMT
DiarrheaGastrointestinal disorders	5/7	1/5
FatigueGeneral disorders	4/7	0/5
HeadacheNervous system disorders	3/7	0/5
Abdominal PainGastrointestinal disorders	2/7	2/5
NauseaGastrointestinal disorders	2/7	0/5
ConstipationGastrointestinal disorders	2/7	0/5
Contact DermatitisSkin and subcutaneous tissue disorders	2/7	0/5
DyspepsiaGastrointestinal disorders	1/7	1/5
FlatulenceGastrointestinal disorders	1/7	1/5
Superficial ThrombophlebitisVascular disorders	1/7	1/5

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)	Antibiotics Prior to FMT	Placebo Prior to FMT	Total
<=18 years	0	0	0
Between 18 and 65 years	7	5	12
>=65 years	0	0	0

Age, Continuous
Age, Continuous(Years)	Antibiotics Prior to FMT	Placebo Prior to FMT	Total
Mean	43.7 ± 9.63	46.6 ± 7.95	44.9 ± 8.71

Sex: Female, Male
Sex: Female, Male(Participants)	Antibiotics Prior to FMT	Placebo Prior to FMT	Total
Female	5	4	9
Male	2	1	3

Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)	Antibiotics Prior to FMT	Placebo Prior to FMT	Total
Hispanic or Latino	0	0	0
Not Hispanic or Latino	6	5	11
Unknown or Not Reported	1	0	1

Race (NIH/OMB)
Race (NIH/OMB)(Participants)	Antibiotics Prior to FMT	Placebo Prior to FMT	Total
American Indian or Alaska Native	0	0	0
Asian	0	0	0
Native Hawaiian or Other Pacific Islander	0	0	0
Black or African American	0	0	0
White	7	5	12
More than one race	0	0	0
Unknown or Not Reported	0	0	0

Region of Enrollment
Region of Enrollment(Participants)	Antibiotics Prior to FMT	Placebo Prior to FMT	Total
United States	7	5	12

Study locations

1 site

University of Minnesota Medical Center
Minneapolis, Minnesota 55455, United States

References and documents

Study documents

Protocol and statistical analysis plan · May 19, 2016

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Feb 22, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT02730962
Lead sponsor: University of Minnesota
Responsible party: Sponsor
First posted: Apr 7, 2016
Start date: Jun 2016
Primary completion: Jan 2018
Completion: Jan 2018
Results posted: Nov 20, 2020
Last update: Feb 22, 2023

Study contacts

Alexander Khoruts, MD

principal investigator · University of Minnesota

Oversight

Data monitoring committee: Yes

View the source record on ClinicalTrials.gov ↗

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This study is terminated, as verified in Feb 2023. You cannot join it, but the record below documents what was studied.

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