Trial Outcomes & Findings for Manipulating the Gut Microbiome Study (NCT NCT03181828)
NCT ID: NCT03181828
Last Updated: 2021-12-15
Results Overview
Difference in the % enrichment of Carbon-13 in blood CO2 as compared to baseline measurement, at sequential time points, after a single bolus of intravenous \[13C\]-Urea,
Recruitment status
TERMINATED
Study phase
PHASE1/PHASE2
Target enrollment
4 participants
Primary outcome timeframe
Time +0 minutes, +30 minutes, +60 minutes, +90 minutes, +120 minutes, +180 minutes, and +240 minutes from time of infused [13C] Urea IV
Results posted on
2021-12-15
Participant Flow
Participant milestones
| Measure |
No Intervention, Then Acetohydroxamic Acid Oral Tablet [Lithostat]
Cross over from No Intervention- Non AHA; Period 1. Subjects (healthy adults and UCD patients) will receive a single oral dose of 60 mg/kg acetohydroxamic acid during one of the treatment periods, based on the randomization assignment determining whether treatment occurs in the first or the second treatment cycle; doses will be rounded to the nearest 250 mg to coincide with the available dosage form since the tablets cannot be scored.
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Acetohydroxamic Acid Oral Tablet [Lithostat], Then No Intervention
All subjects (healthy adults and UCD patients) will receive a single oral dose of 60 mg/kg acetohydroxamic acid during one of the treatment periods, based on the randomization assignment determining whether treatment occurs in the first or the second treatment cycle; doses will be rounded to the nearest 250 mg to coincide with the available dosage form since the tablets cannot be scored. Patients will be instructed to fast for 4 hours prior to the study; subsequently, the 13C-Urea tracer will be administered 60 minutes after the ingestion of the acetohydroxamic acid dose.
Acetohydroxamic Acid Oral Tablet \[Lithostat\]: AHA:
Acetohydroxamic acid has been an FDA approved medication for the treatment of struvite nephrolithiasis for over 25 years. According to the prescribing information, about 150 patients, including children, have been treated, most for periods of more than 1 year.
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|---|---|---|
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Overall Study
STARTED
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2
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2
|
|
Overall Study
COMPLETED
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2
|
2
|
|
Overall Study
NOT COMPLETED
|
0
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0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Manipulating the Gut Microbiome Study
Baseline characteristics by cohort
| Measure |
No Intervention Then Acetohydroxamic Acid Oral Tablet
n=2 Participants
Participants completed a 4-h study in the fasted state without acetohydroxamic acid. 3 days later, participants then completed an identical 4-h study in the fasted state, after having received a single oral dose of 60 mg/kg acetohydroxamic acid (rounded to the nearest 250 mg).
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Acetohydroxamic Acid Oral Tablet Then No Intervention
n=2 Participants
Participants receive a single oral dose of 60 mg/kg acetohydroxamic acid (rounded to the nearest 250 mg) in the fasted state on the morning of the study. After completion of the 4-h study, participants then enter a wash-out period of 3 days. Participants then completed an identical 4-h study in the fasted state without acetohydroxamic acid.
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Total
n=4 Participants
Total of all reporting groups
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|---|---|---|---|
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Age, Categorical
<=18 years
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0 Participants
n=5 Participants
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0 Participants
n=7 Participants
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0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
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2 Participants
n=5 Participants
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2 Participants
n=7 Participants
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4 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
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0 Participants
n=5 Participants
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0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
47 years
n=5 Participants
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40 years
n=7 Participants
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43.5 years
n=5 Participants
|
|
Sex: Female, Male
Female
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1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 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
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 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
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1 Participants
n=5 Participants
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2 Participants
n=7 Participants
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3 Participants
n=5 Participants
|
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Race (NIH/OMB)
White
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0 Participants
n=5 Participants
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0 Participants
n=7 Participants
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0 Participants
n=5 Participants
|
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Race (NIH/OMB)
More than one race
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0 Participants
n=5 Participants
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0 Participants
n=7 Participants
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0 Participants
n=5 Participants
|
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Race (NIH/OMB)
Unknown or Not Reported
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0 Participants
n=5 Participants
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0 Participants
n=7 Participants
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0 Participants
n=5 Participants
|
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Region of Enrollment
United States
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2 participants
n=5 Participants
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2 participants
n=7 Participants
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4 participants
n=5 Participants
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PRIMARY outcome
Timeframe: Time +0 minutes, +30 minutes, +60 minutes, +90 minutes, +120 minutes, +180 minutes, and +240 minutes from time of infused [13C] Urea IVDifference in the % enrichment of Carbon-13 in blood CO2 as compared to baseline measurement, at sequential time points, after a single bolus of intravenous \[13C\]-Urea,
Outcome measures
| Measure |
Acetohydroxamic Acid Oral Tablet
n=4 Participants
Participants receive a single oral dose of 60 mg/kg acetohydroxamic acid (rounded to the nearest 250 mg) in the fasted state on the morning of the study.
|
No Intervention
n=4 Participants
Participants completed a 4-h study in the fasted state without acetohydroxamic acid.
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|---|---|---|
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Atom Percent Excess of 13CO2
0 min
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0 Atom % Excess
Standard Deviation 0
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0 Atom % Excess
Standard Deviation 0
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Atom Percent Excess of 13CO2
30 min
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-0.00216 Atom % Excess
Standard Deviation 0.00376
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0.00268 Atom % Excess
Standard Deviation 0.00531
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Atom Percent Excess of 13CO2
60 min
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0.000959 Atom % Excess
Standard Deviation 0.00130
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0.000318 Atom % Excess
Standard Deviation 0.0105
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Atom Percent Excess of 13CO2
90 min
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0.00129 Atom % Excess
Standard Deviation 0.00101
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0.00336 Atom % Excess
Standard Deviation 0.00583
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Atom Percent Excess of 13CO2
120 min
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0.00152 Atom % Excess
Standard Deviation 0.00117
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0.00277 Atom % Excess
Standard Deviation 0.00528
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Atom Percent Excess of 13CO2
180
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-0.00392 Atom % Excess
Standard Deviation 0.00561
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-0.000982 Atom % Excess
Standard Deviation 0.00122
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Atom Percent Excess of 13CO2
240
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-0.000537 Atom % Excess
Standard Deviation 0.00386
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0.00203 Atom % Excess
Standard Deviation 0.00617
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SECONDARY outcome
Timeframe: Time +O minutes, +30 minutes, +60 minutes, +90 minutes, +120 minutes, +180 minutes, and +240 minutes from time of [13C] Urea IVConcentration of urea labeled with Carbon-13
Outcome measures
| Measure |
Acetohydroxamic Acid Oral Tablet
n=4 Participants
Participants receive a single oral dose of 60 mg/kg acetohydroxamic acid (rounded to the nearest 250 mg) in the fasted state on the morning of the study.
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No Intervention
n=4 Participants
Participants completed a 4-h study in the fasted state without acetohydroxamic acid.
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|---|---|---|
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Blood [13C]-Urea
0 Min
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0 micromol/L
Standard Deviation 0
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0 micromol/L
Standard Deviation 0
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Blood [13C]-Urea
30 Min
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174.9 micromol/L
Standard Deviation 43.57
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199.5 micromol/L
Standard Deviation 9.12
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Blood [13C]-Urea
60 Min
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151.9 micromol/L
Standard Deviation 30.05
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165.2 micromol/L
Standard Deviation 6.07
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Blood [13C]-Urea
90 Min
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140.9 micromol/L
Standard Deviation 12.48
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152.4 micromol/L
Standard Deviation 6.14
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Blood [13C]-Urea
120 Min
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137.3 micromol/L
Standard Deviation 9.58
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136.8 micromol/L
Standard Deviation 6.65
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Blood [13C]-Urea
180 Min
|
127.8 micromol/L
Standard Deviation 9.87
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126.5 micromol/L
Standard Deviation 7.78
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Blood [13C]-Urea
240
|
119.9 micromol/L
Standard Deviation 11.93
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117.2 micromol/L
Standard Deviation 9.95
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Adverse Events
Acetohydroxamic Acid Oral Tablet
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
No Intervention
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Acetohydroxamic Acid Oral Tablet
n=4 participants at risk
Participants receive a single oral dose of 60 mg/kg acetohydroxamic acid (rounded to the nearest 250 mg) in the fasted state on the morning of the study.
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No Intervention
n=4 participants at risk
Participants completed a 4-h study in the fasted state without acetohydroxamic acid.
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|---|---|---|
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Nervous system disorders
Headache
|
100.0%
4/4 • Number of events 4 • 1 week
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0.00%
0/4 • 1 week
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Nervous system disorders
Nausea
|
50.0%
2/4 • Number of events 2 • 1 week
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0.00%
0/4 • 1 week
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Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place