Interventional Bioremediation of Microbiota in Metabolic Syndrome

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.