Trial Outcomes & Findings for Interventional Bioremediation of Microbiota in Metabolic Syndrome (NCT NCT02730962)

NCT ID: NCT02730962

Last Updated: 2023-02-22

Results Overview

Insulin sensitivity measured by standard euglycemic insulin clamp.

• Recruitment status: TERMINATED
• Study phase: PHASE2
• Target enrollment: 12 participants
• Primary outcome timeframe: 10 weeks
• Results posted on: 2023-02-22

Participant Flow

Participant milestones

Measure	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: Vancomycin 3 times a day for 7 days Neomycin: Neomycin 3 times a day for 1 day Clindamycin: Clindamycin 3 times a day for 5 days Fecal Microbiota Transplantation: FMT conducted via colonoscopy	Placebo Prior to FMT One week prior to FMT, a course of three sugar pills identical to each antibiotic. Placebo: Placebo pills identical in appearance to each antibiotics to be taken on the same schedule as each antibiotic Fecal Microbiota Transplantation: FMT conducted via colonoscopy
Overall Study STARTED	7	5
Overall Study COMPLETED	7	5
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Interventional Bioremediation of Microbiota in Metabolic Syndrome

Baseline characteristics by cohort

Measure	Antibiotics Prior to FMT n=7 Participants One week prior to FMT, a course of three oral antibiotics are taken: Vancomycin 500mg, Neomycin 1000mg, and Clindamycin 300mg. Vancomycin: Vancomycin 3 times a day for 7 days Neomycin: Neomycin 3 times a day for 1 day Clindamycin: Clindamycin 3 times a day for 5 days Fecal Microbiota Transplantation: FMT conducted via colonoscopy	Placebo Prior to FMT n=5 Participants One week prior to FMT, a course of three sugar pills identical to each antibiotic. Placebo: Placebo pills identical in appearance to each antibiotics to be taken on the same schedule as each antibiotic Fecal Microbiota Transplantation: FMT conducted via colonoscopy	Total n=12 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	7 Participants n=5 Participants	5 Participants n=7 Participants	12 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	43.7 Years STANDARD_DEVIATION 9.63 • n=5 Participants	46.6 Years STANDARD_DEVIATION 7.95 • n=7 Participants	44.9 Years STANDARD_DEVIATION 8.71 • n=5 Participants
Sex: Female, Male Female	5 Participants n=5 Participants	4 Participants n=7 Participants	9 Participants n=5 Participants
Sex: Female, Male Male	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	6 Participants n=5 Participants	5 Participants n=7 Participants	11 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	7 Participants n=5 Participants	5 Participants n=7 Participants	12 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	7 Participants n=5 Participants	5 Participants n=7 Participants	12 Participants n=5 Participants

PRIMARY outcome

Timeframe: 10 weeks

Population: Due to errors in formulation of the euglycemic insulin clamp solutions, insulin sensitivity data is not able to be analyzed.

Insulin sensitivity measured by standard euglycemic insulin clamp.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 7 days

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

Outcome measures

Measure	Antibiotics Prior to FMT n=7 Participants One week prior to FMT, a course of three oral antibiotics are taken: Vancomycin 500mg, Neomycin 1000mg, and Clindamycin 300mg. Vancomycin: Vancomycin 3 times a day for 7 days Neomycin: Neomycin 3 times a day for 1 day Clindamycin: Clindamycin 3 times a day for 5 days Fecal Microbiota Transplantation: FMT conducted via colonoscopy	Placebo Prior to FMT n=5 Participants One week prior to FMT, a course of three sugar pills identical to each antibiotic. Placebo: Placebo pills identical in appearance to each antibiotics to be taken on the same schedule as each antibiotic Fecal Microbiota Transplantation: FMT conducted via colonoscopy
Microbiome Composition Baseline	3.3 unitless measure Standard Deviation 0.5	3.3 unitless measure Standard Deviation 0.5
Microbiome Composition 7 days post FMT	3.3 unitless measure Standard Deviation 0.5	1.2 unitless measure Standard Deviation 0.2

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Antibiotics Prior to FMT n=7 Participants One week prior to FMT, a course of three oral antibiotics are taken: Vancomycin 500mg, Neomycin 1000mg, and Clindamycin 300mg. Vancomycin: Vancomycin 3 times a day for 7 days Neomycin: Neomycin 3 times a day for 1 day Clindamycin: Clindamycin 3 times a day for 5 days Fecal Microbiota Transplantation: FMT conducted via colonoscopy	Placebo Prior to FMT n=5 Participants One week prior to FMT, a course of three sugar pills identical to each antibiotic. Placebo: Placebo pills identical in appearance to each antibiotics to be taken on the same schedule as each antibiotic Fecal Microbiota Transplantation: FMT conducted via colonoscopy
Changes in Fecal Bacterial Composition Associated With FMT Overall Antibiotic and Placebo Conditioning Groups) by Laboratory Analysis.	5 percent relative abundance Standard Deviation 2	17 percent relative abundance Standard Deviation 1

SECONDARY outcome

Timeframe: 10 weeks

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

Outcome measures

Measure	Antibiotics Prior to FMT n=7 Participants One week prior to FMT, a course of three oral antibiotics are taken: Vancomycin 500mg, Neomycin 1000mg, and Clindamycin 300mg. Vancomycin: Vancomycin 3 times a day for 7 days Neomycin: Neomycin 3 times a day for 1 day Clindamycin: Clindamycin 3 times a day for 5 days Fecal Microbiota Transplantation: FMT conducted via colonoscopy	Placebo Prior to FMT n=5 Participants One week prior to FMT, a course of three sugar pills identical to each antibiotic. Placebo: Placebo pills identical in appearance to each antibiotics to be taken on the same schedule as each antibiotic Fecal Microbiota Transplantation: FMT conducted via colonoscopy
Adverse Event Rates	6 Number of adverse events	4 Number of adverse events

Adverse Events

Antibiotics Prior to FMT

Serious events: 1 serious events

Other events: 6 other events

Deaths: 0 deaths

Placebo Prior to FMT

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Serious adverse events

Measure	Antibiotics Prior to FMT n=7 participants at risk One week prior to FMT, a course of three oral antibiotics are taken: Vancomycin 500mg, Neomycin 1000mg, and Clindamycin 300mg. Vancomycin: Vancomycin 3 times a day for 7 days Neomycin: Neomycin 3 times a day for 1 day Clindamycin: Clindamycin 3 times a day for 5 days Fecal Microbiota Transplantation: FMT conducted via colonoscopy	Placebo Prior to FMT n=5 participants at risk One week prior to FMT, a course of three sugar pills identical to each antibiotic. Placebo: Placebo pills identical in appearance to each antibiotics to be taken on the same schedule as each antibiotic Fecal Microbiota Transplantation: FMT conducted via colonoscopy
Gastrointestinal disorders Clostridium Difficile Infection	14.3% 1/7 • Number of events 1 • 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.	0.00% 0/5 • 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.

Other adverse events

Measure	Antibiotics Prior to FMT n=7 participants at risk One week prior to FMT, a course of three oral antibiotics are taken: Vancomycin 500mg, Neomycin 1000mg, and Clindamycin 300mg. Vancomycin: Vancomycin 3 times a day for 7 days Neomycin: Neomycin 3 times a day for 1 day Clindamycin: Clindamycin 3 times a day for 5 days Fecal Microbiota Transplantation: FMT conducted via colonoscopy	Placebo Prior to FMT n=5 participants at risk One week prior to FMT, a course of three sugar pills identical to each antibiotic. Placebo: Placebo pills identical in appearance to each antibiotics to be taken on the same schedule as each antibiotic Fecal Microbiota Transplantation: FMT conducted via colonoscopy
Gastrointestinal disorders Diarrhea	71.4% 5/7 • Number of events 9 • 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.	20.0% 1/5 • Number of events 2 • 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.
Gastrointestinal disorders Abdominal Pain	28.6% 2/7 • Number of events 2 • 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.	40.0% 2/5 • Number of events 2 • 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.
Gastrointestinal disorders Bloating	14.3% 1/7 • Number of events 1 • 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.	0.00% 0/5 • 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.
Gastrointestinal disorders Nausea	28.6% 2/7 • Number of events 2 • 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.	0.00% 0/5 • 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.
Gastrointestinal disorders Constipation	28.6% 2/7 • Number of events 3 • 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.	0.00% 0/5 • 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.
Nervous system disorders Headache	42.9% 3/7 • Number of events 4 • 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.	0.00% 0/5 • 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.
General disorders Chills	14.3% 1/7 • Number of events 1 • 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.	0.00% 0/5 • 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.
Skin and subcutaneous tissue disorders Contact Dermatitis	28.6% 2/7 • Number of events 2 • 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.	0.00% 0/5 • 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.
Gastrointestinal disorders Dyspepsia	14.3% 1/7 • Number of events 2 • 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.	20.0% 1/5 • Number of events 1 • 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.
General disorders Fatigue	57.1% 4/7 • Number of events 4 • 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.	0.00% 0/5 • 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.
General disorders Fever	14.3% 1/7 • Number of events 1 • 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.	0.00% 0/5 • 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.
Gastrointestinal disorders Flatulence	14.3% 1/7 • Number of events 1 • 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.	20.0% 1/5 • Number of events 1 • 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.
Psychiatric disorders Insomnia	14.3% 1/7 • Number of events 1 • 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.	0.00% 0/5 • 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.
Vascular disorders Superficial Thrombophlebitis	14.3% 1/7 • Number of events 1 • 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.	20.0% 1/5 • Number of events 1 • 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.

Additional Information

Dr. Alexander Khoruts

University of Minnesota

Phone: 612-624-2101

Email: khoru001@umn.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place