Trial Outcomes & Findings for Proton Pump Inhibitors and Dysbiosis in Cirrhosis (NCT NCT01458990)

NCT ID: NCT01458990

Last Updated: 2018-03-19

Results Overview

Analysis at baseline will be compared to that at 2 weeks using Multitagged sequencing. Number of patients with overgrowth of oral microbiota in their stool after PPI therapy withdrawal or initiation were specifically analyzed.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 60 participants
• Primary outcome timeframe: 2 weeks
• Results posted on: 2018-03-19

Participant Flow

Participants recruited from McGuire VAMC hepatology clinics

Participant milestones

Measure	PPI Inititation Adding 40mg omeprazole QD for 14 days	PPI Withdrawal The intervention here is systematically withdrawing chronic PPI for 14 days
Overall Study STARTED	45	15
Overall Study COMPLETED	45	15
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Proton Pump Inhibitors and Dysbiosis in Cirrhosis

Baseline characteristics by cohort

Measure	PPI Inititation n=45 Participants Adding 40mg omeprazole QD for 14 days	PPI Withdrawal n=15 Participants The intervention here is systematically withdrawing chronic PPI for 14 days	Total n=60 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	40 Participants n=5 Participants	14 Participants n=7 Participants	54 Participants n=5 Participants
Age, Categorical >=65 years	5 Participants n=5 Participants	1 Participants n=7 Participants	6 Participants n=5 Participants
Age, Continuous	58 years STANDARD_DEVIATION 7.6 • n=5 Participants	59 years STANDARD_DEVIATION 6.7 • n=7 Participants	58 years STANDARD_DEVIATION 7.0 • n=5 Participants
Sex: Female, Male Female	3 Participants n=5 Participants	1 Participants n=7 Participants	4 Participants n=5 Participants
Sex: Female, Male Male	42 Participants n=5 Participants	14 Participants n=7 Participants	56 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	16 Participants n=5 Participants	6 Participants n=7 Participants	22 Participants n=5 Participants
Race (NIH/OMB) White	29 Participants n=5 Participants	9 Participants n=7 Participants	38 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	45 participants n=5 Participants	15 participants n=7 Participants	60 participants n=5 Participants

PRIMARY outcome

Timeframe: 2 weeks

Population: Comparison were made between groups on/off PPI therapy using Linear discriminant analysis effect size (LEFSe) and using the Quantitative Insights Into Microbial Ecology (QIIME) pipeline and also the relative proportion (%) of oral-origin microbiota were studied

Analysis at baseline will be compared to that at 2 weeks using Multitagged sequencing. Number of patients with overgrowth of oral microbiota in their stool after PPI therapy withdrawal or initiation were specifically analyzed.

Outcome measures

Measure	PPI Inititation n=45 Participants Adding 40mg omeprazole QD for 14 days Omeprazole: 20mg PO BID for 20 days	PPI Withdrawal n=15 Participants The intervention here is systematically withdrawing chronic PPI for 14 days Omeprazole: 20mg PO BID for 20 days
Number of Patients With Overgrowth of Oral Microbiota in Their Stool After PPI Therapy Withdrawal or Initiation	45 Participants	15 Participants

SECONDARY outcome

Timeframe: 2 weeks

Population: No safety or tolerability issues were seen during the study

Analysis at baseline will be compared to that at 2 weeks. This will be specifically, changes in those with PPI withdrawal compared to those with PPI initiation

Outcome measures

Measure	PPI Inititation n=45 Participants Adding 40mg omeprazole QD for 14 days Omeprazole: 20mg PO BID for 20 days	PPI Withdrawal n=15 Participants The intervention here is systematically withdrawing chronic PPI for 14 days Omeprazole: 20mg PO BID for 20 days
Number of Patients With Adverse Events During Initiation or Withdrawal of PPI Therapy	0 Participants	0 Participants

Adverse Events

PPI Inititation

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

PPI Withdrawal

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

Jasmohan Bajaj

Hunter Holmes McGuire VA Medical Center

Phone: 804 675 5802

Email: jasmohan.bajaj@va.gov

Results disclosure agreements

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