Trial Outcomes & Findings for Treating Bacterial Overgrowth in Parkinson's Disease (NCT NCT02470780)

NCT ID: NCT02470780

Last Updated: 2024-03-01

Results Overview

OFF time is the time in which levodopa has ceased to be effective and Parkinsonian symptoms reemerge.

• Recruitment status: COMPLETED
• Study phase: PHASE2/PHASE3
• Target enrollment: 4 participants
• Primary outcome timeframe: baseline to 1 month and 3 months; new baseline at 3 months to 4 months and 6 months
• Results posted on: 2024-03-01

Participant Flow

Participant milestones

Measure	Rifaximin (3-month Follow-up) Participants in this group received a 7-day treatment with Rifaximin and were followed for three months. Participants were blinded to their treatment assignment until the conclusions of the 3-month visit.	Placebo Then Rifaximin (6-month Follow-up) Participants in this group received a 7-day treatment with placebo and were followed for three months. Participants were blinded to their treatment assignment until the conclusions of the 3-month visit. At the end of the 3-month visit, they were given a 7-day course of Rifaximin and followed for an additional 3 months.
Phase 1 STARTED	2	2
Phase 1 COMPLETED	2	2
Phase 1 NOT COMPLETED	0	0
Phase 2 STARTED	0	2
Phase 2 COMPLETED	0	2
Phase 2 NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Treating Bacterial Overgrowth in Parkinson's Disease

Baseline characteristics by cohort

Measure	Rifaximin (3-month Follow-up) n=2 Participants Participants in this group received a 7-day treatment with Rifaximin and were followed for three months. Participants were blinded to their treatment assignment until the conclusions of the 3-month visit.	Placebo Then Rifaximin (6-month Follow-up) n=2 Participants Participants in this group received a 7-day treatment with placebo and were followed for three months. Participants were blinded to their treatment assignment until the conclusions of the 3-month visit. At the end of the 3-month visit, they were given a 7-day course of Rifaximin and followed for an additional 3 months.	Total n=4 Participants Total of all reporting groups
Age, Continuous	72.2 years STANDARD_DEVIATION 5.3 • n=5 Participants	61.2 years STANDARD_DEVIATION 5.8 • n=7 Participants	66.7 years STANDARD_DEVIATION 7.8 • n=5 Participants
Sex: Female, Male Female	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	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	2 Participants n=5 Participants	2 Participants n=7 Participants	4 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
OFF time	1.4 hours STANDARD_DEVIATION 2.0 • n=5 Participants	5.2 hours STANDARD_DEVIATION 0.7 • n=7 Participants	3.3 hours STANDARD_DEVIATION 2.5 • n=5 Participants

PRIMARY outcome

Timeframe: baseline to 1 month and 3 months; new baseline at 3 months to 4 months and 6 months

Population: Participants in this group completed the study at 3 months after treatment with rifaximin. They were not assessed at 4 and 6 months.

OFF time is the time in which levodopa has ceased to be effective and Parkinsonian symptoms reemerge.

Outcome measures

Measure	Rifaximin (3-month Follow-up) n=2 Participants Participants in this group received a 7-day treatment with Rifaximin and were followed for three months. Participants were blinded to their treatment assignment until the conclusions of the 3-month visit.	Placebo Then Rifaximin n=2 Participants Participants in this group received a 7-day treatment with placebo and then received rifaximin.
Change in "Off" Time as Measured by Patient Diary 1 month change from baseline	-1.4 hours Standard Deviation 2.0	-2.8 hours Standard Deviation 0.7
Change in "Off" Time as Measured by Patient Diary 3 month change from baseline	-0.9 hours Standard Deviation 1.3	-2.0 hours Standard Deviation 2.8
Change in "Off" Time as Measured by Patient Diary 4 month change from new baseline (P to R group only)	—	-1.4 hours Standard Deviation 2.5
Change in "Off" Time as Measured by Patient Diary 6 month change from new baseline (P to R group only)	—	-2.2 hours Standard Deviation 3.5

PRIMARY outcome

Timeframe: 1, 3, and 6 months

Population: This outcome measure was not analyzed due to low subject enrollment as well as poor subject compliance or data quality in some cases. No data were collected for this outcome measure.

This outcome measure was not analyzed due to low subject enrollment as well as poor subject compliance or data quality in some cases.

Outcome measures

Outcome data not reported

Adverse Events

Rifaximin

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo

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

Hilary Perez PhD

University of Cincinnati/UC Health

Phone: 5135582577

Email: perezhe@ucmail.uc.edu

Results disclosure agreements

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