Trial Outcomes & Findings for Effects of Gastric Acid on Colonic Microbiome (NCT NCT01901276)

NCT ID: NCT01901276

Last Updated: 2024-08-15

Results Overview

In order to assess the diversity of the colonic microbiome, the Shannon diversity index will be calculated for each subject: * After four weeks of no acid suppression (Week 0 vs. Week 4) * After four weeks of twice daily PPI (Week 4 vs. Week 8) The Shannon diversity index is a mathematical measure of species diversity in a given community. The Shannon index is calculated as: -∑\[(pi)×ln(pi)\] where H is the Shannon diversity index, and pi is the proportion of individuals of i-th species in a whole community. The minimum value of the Shannon diversity index is 0, which indicates there's no diversity - only one species is found in that habitat. There is no upper limit to the Shannon index. The higher the value of H, the higher the diversity of species in a particular community.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

14 participants

Primary outcome timeframe

Baseline (Week 0), Week 4, Week 8

Results posted on

2024-08-15

Participant Flow

Participant milestones

Participant milestones
Measure	Omeprazole 40 mg Bid Participants will take Omeprazole 40 mg twice daily for 4 weeks.	No Treatment Participants will not receive a study intervention.
No PPI: Week 0 to Week 4 STARTED	0	14
No PPI: Week 0 to Week 4 COMPLETED	0	12
No PPI: Week 0 to Week 4 NOT COMPLETED	0	2
On PPI: Week 4 to Week 8 STARTED	12	0
On PPI: Week 4 to Week 8 COMPLETED	12	0
On PPI: Week 4 to Week 8 NOT COMPLETED	0	0
Randomization: Week 8 to Week 12 STARTED	6	6
Randomization: Week 8 to Week 12 COMPLETED	6	6
Randomization: Week 8 to Week 12 NOT COMPLETED	0	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Omeprazole 40 mg Bid Participants will take Omeprazole 40 mg twice daily for 4 weeks.	No Treatment Participants will not receive a study intervention.
No PPI: Week 0 to Week 4 Withdrawal by Subject	0	2

Baseline Characteristics

Effects of Gastric Acid on Colonic Microbiome

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Omeprazole 40 mg Bid x 4-8 Weeks n=12 Participants See study description for further details. Omeprazole 40 mg bid: As above.
Age, Continuous	40 years STANDARD_DEVIATION 11 • n=5 Participants
Sex: Female, Male Female	3 Participants n=5 Participants
Sex: Female, Male Male	9 Participants n=5 Participants
Region of Enrollment United States	12 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline (Week 0), Week 4, Week 8

Outcome measures

Outcome measures
Measure	Omeprazole 40 mg Bid x 4-8 Weeks n=12 Participants Includes all participants who completed the study.
Shannon Diversity Index Measuring Change in Microbiome Diversity Change in Shannon indices from Baseline to Week 4 (no PPIs)	0.18 Shannon index Interval -0.32 to 0.68
Shannon Diversity Index Measuring Change in Microbiome Diversity Change in Shannon indices from Week 4 to Week 8 (on PPIs)	0.14 Shannon index Interval -0.23 to 0.51

Adverse Events

Omeprazole 40 mg Bid x 4-8 Weeks

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

Daniel Freedberg, MD, MS

Columbia University Medical Center

Phone: 212-305-1021

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place