Interventional Bioremediation of Microbiota in Metabolic Syndrome

NCT02730962 | Terminated Phase 2 Results DMC

• 1 other identifier: GI-2015-22791
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Pre-Diabetes

Outcome Measures

Primary Outcomes (1)

• Insulin Sensitivity

  Insulin sensitivity measured by standard euglycemic insulin clamp.

  10 weeks

Secondary Outcomes (3)

• Microbiome Composition

  7 days

• Changes in Fecal Bacterial Composition Associated With FMT Overall Antibiotic and Placebo Conditioning Groups) by Laboratory Analysis.

  Baseline and 10 weeks

• Adverse Event Rates

  10 weeks

Study Arms (2)

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.

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.

Other: Placebo; Procedure: Fecal Microbiota Transplantation

Interventions

Vancomycin DRUG

Vancomycin 3 times a day for 7 days

Antibiotics prior to FMT

Placebo OTHER

Placebo pills identical in appearance to each antibiotics to be taken on the same schedule as each antibiotic

Placebo prior to FMT

Neomycin DRUG

Neomycin 3 times a day for 1 day

Antibiotics prior to FMT

Clindamycin DRUG

Clindamycin 3 times a day for 5 days

Antibiotics prior to FMT

Fecal Microbiota Transplantation PROCEDURE

FMT conducted via colonoscopy

Antibiotics prior to FMT; Placebo prior to FMT

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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).
• 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.

Sponsors & Collaborators

• University of Minnesota: lead

Study Sites (1)

University of Minnesota Medical Center

Minneapolis, Minnesota, 55455, United States

Location

MeSH Terms

Conditions

Glucose Intolerance

Interventions

Vancomycin; Neomycin; Clindamycin; Fecal Microbiota Transplantation

Condition Hierarchy (Ancestors)

Hyperglycemia; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Glycopeptides; Glycoconjugates; Carbohydrates; Peptides; Amino Acids, Peptides, and Proteins; Aminoglycosides; Glycosides; Lincomycin; Lincosamides; Pyrrolidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Biological Therapy; Therapeutics

Results Point of Contact

• Title: Dr. Alexander Khoruts
• Organization: University of Minnesota

khoru001@umn.edu

612-624-2101

Study Officials

• Alexander Khoruts, MD

  University of Minnesota

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 16, 2016
• First Posted: April 7, 2016
• Study Start: June 1, 2016
• Primary Completion: January 1, 2018
• Study Completion: January 1, 2018
• Last Updated: February 22, 2023
• Results First Posted: November 20, 2020

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)