Trial Outcomes & Findings for Effects of Lubiprostone on Small Bowel and Colonic Bacteria: A Correlation Study With Segmental and Whole Gut Transit (NCT NCT00844831)

NCT ID: NCT00844831

Last Updated: 2017-07-27

Results Overview

Percent of patients with bacterial overgrowth before and after treatment.

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 25 participants
• Primary outcome timeframe: 28 days
• Results posted on: 2017-07-27

Participant Flow

Subjects recruited from outpatient clinics and advertisement

Study consisted of a 4-week run-in period to wash out prior therapy for constipation. Subjects may withdraw if they can not stay off their medications for constipation.

Participant milestones

Measure	Lubiprostone Open Label
Overall Study STARTED	25
Overall Study COMPLETED	19
Overall Study NOT COMPLETED	6

Reasons for withdrawal

Measure	Lubiprostone Open Label
Overall Study Withdrawal by Subject	4
Overall Study Adverse Event	1
Overall Study Physician Decision	1

Baseline Characteristics

Effects of Lubiprostone on Small Bowel and Colonic Bacteria: A Correlation Study With Segmental and Whole Gut Transit

Baseline characteristics by cohort

Measure	Lubiprostone Open Label n=25 Participants
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	25 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	52 years STANDARD_DEVIATION 5 • n=5 Participants
Sex: Female, Male Female	22 Participants n=5 Participants
Sex: Female, Male Male	3 Participants n=5 Participants
Region of Enrollment United States	25 participants n=5 Participants

PRIMARY outcome

Timeframe: 28 days

Population: ITT

Percent of patients with bacterial overgrowth before and after treatment.

Outcome measures

Measure	Before Open Label Lubiprostone n=19 Participants Before 4-wk treatment period with open label lubiprostone 24 mcg tablet po twice daily.	After Open Label Treatment n=19 Participants After 4-wk treatment period with open label lubiprostone 24 mcg tablet po twice daily
Presence of Small Intestinal Bacterial Overgrowth	8 Participants	9 Participants

SECONDARY outcome

Timeframe: 28 days

Population: We were unable to obtain the smart pills for this section of the protocol.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 28 days

SIBO was measured before and after treatment.

Outcome measures

Measure	Before Open Label Lubiprostone n=19 Participants Before 4-wk treatment period with open label lubiprostone 24 mcg tablet po twice daily.	After Open Label Treatment n=19 Participants After 4-wk treatment period with open label lubiprostone 24 mcg tablet po twice daily
Small Intestinal Bacterial Overgrowth (SIBO)	8 participants	9 participants

Adverse Events

Lubiprostone Open Label

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	Lubiprostone Open Label n=25 participants at risk 4-wk treatment period with open label lubiprostone 24 mcg tablet po twice daily
Nervous system disorders Transient ischemic attack	4.0% 1/25 • Number of events 1

Other adverse events

Adverse event data not reported

Additional Information

John M. Wo, MD

University of Louisville

Phone: 502-852-6991

Email: johnwogi@gmail.com

Results disclosure agreements

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