Trial Outcomes & Findings for The Effect of an Antibiotic on the Production of Uremic Toxins by the Gut Microbiome (NCT NCT03452189)

Results Overview

Plasma concentrations of IS were measured by HPLC (high pressure liquid chromatography). Assessed weekly between day 0 and Week 4; change from baseline/day 0 to Week 4 reported

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

15 participants

Primary outcome timeframe

4 weeks

Results posted on

2021-03-26

Participant Flow

Participant milestones

Participant milestones
Measure	250mg of Oral Vancomycin First, Then Placebo 250mg of Oral Vancomycin given for 3 months then crossed over to placebo for additional 3 months (no washout period).	Placebo First, Then 250mg of Oral Vancomycin Placebo given for 3 months then crossed over to 250 mg of Oral Vancomycin for additional 3 months (no washout period).
First Intervention (3 Months) STARTED	10	5
First Intervention (3 Months) COMPLETED	5	5
First Intervention (3 Months) NOT COMPLETED	5	0
Intervention 2 (3 Months) STARTED	5	5
Intervention 2 (3 Months) COMPLETED	5	5
Intervention 2 (3 Months) NOT COMPLETED	0	0

Reasons for withdrawal

Reasons for withdrawal
Measure	250mg of Oral Vancomycin First, Then Placebo 250mg of Oral Vancomycin given for 3 months then crossed over to placebo for additional 3 months (no washout period).	Placebo First, Then 250mg of Oral Vancomycin Placebo given for 3 months then crossed over to 250 mg of Oral Vancomycin for additional 3 months (no washout period).
First Intervention (3 Months) Adverse Event	1	0
First Intervention (3 Months) insufficient samples of plasma and stool	4	0

Baseline Characteristics

The Effect of an Antibiotic on the Production of Uremic Toxins by the Gut Microbiome

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo First or 250mg of Oral Vancomycin First (Crossover After 3 Months) n=15 Participants Total cohort
Age, Continuous	57.6 years STANDARD_DEVIATION 9 • n=5 Participants
Sex: Female, Male Female	4 Participants n=5 Participants
Sex: Female, Male Male	11 Participants n=5 Participants
Race/Ethnicity, Customized White	2 Participants n=5 Participants
Race/Ethnicity, Customized Black	3 Participants n=5 Participants
Race/Ethnicity, Customized Asian	2 Participants n=5 Participants
Race/Ethnicity, Customized Hispanic	6 Participants n=5 Participants
Race/Ethnicity, Customized Other or more than one	2 Participants n=5 Participants

PRIMARY outcome

Timeframe: 4 weeks

Population: As there was no "washout period" following vancomycin, for the analysis of vancomycin effect, investigators compared the changes in solute levels in all 10 subjects while receiving vancomycin to the changes seen in the 5 "Z" series subjects while receiving placebo as the initial treatment.

Plasma concentrations of IS were measured by HPLC (high pressure liquid chromatography). Assessed weekly between day 0 and Week 4; change from baseline/day 0 to Week 4 reported

Outcome measures

Outcome measures
Measure	250mg of Oral Vancomycin First, Then Placebo n=10 Participants 250mg of Oral Vancomycin given for 3 months then crossed over to placebo for additional 3 months (no washout period).	Placebo First, Then 250mg of Oral Vancomycin n=5 Participants Placebo given for 3 months then crossed over to 250 mg of Oral Vancomycin for additional 3 months (no washout period).
Change in Plasma Concentration Measure of Indoxyl Sulphate (IS)	-25.31 µM/ml Standard Deviation 36.3	9.71 µM/ml Standard Deviation 49.80

PRIMARY outcome

Timeframe: 4 weeks

Population: As there was no "washout period" following vancomycin, for the analysis of vancomycin effect, investigators compared the changes in solute levels in all 10 subjects while receiving vancomycin to the changes seen in the 5 "Z" series subjects while receiving placebo as the initial treatment.

Plasma concentrations of P-Cresyl Sulphate (PCS) were measured by HPLC (high pressure liquid chromatography) Assessed weekly between day 0 and Week 4; change from baseline/day 0 to Week 4 reported

Outcome measures

Outcome measures
Measure	250mg of Oral Vancomycin First, Then Placebo n=10 Participants 250mg of Oral Vancomycin given for 3 months then crossed over to placebo for additional 3 months (no washout period).	Placebo First, Then 250mg of Oral Vancomycin n=5 Participants Placebo given for 3 months then crossed over to 250 mg of Oral Vancomycin for additional 3 months (no washout period).
Change in Plasma Concentration Measure P-Cresyl Sulphate (PCS)	-73.51 µM/ml Standard Deviation 127.00	0.64 µM/ml Standard Deviation 79.50

Adverse Events

250mg of Oral Vancomycin First

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo First

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Jerome Lowenstein

NYU Langone Health

Phone: +1 212 263 5635

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place