Trial Outcomes & Findings for Neomycin and Rifaximin Plus Neomycin in Treating Methane Positive Constipation Predominant Irritable Bowel Syndrome (NCT NCT00945334)

Results Overview

Visual analog scale (VAS) score for constipation: Severity was rated using a VAS from 0 to 100 units (with 0 = no symptom and 100 = severe symptoms).

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

37 participants

Primary outcome timeframe

1 year

Results posted on

2015-08-10

Participant Flow

Participant milestones

Participant milestones
Measure	Group 1 Group 1 will receive neomycin (500 mg po bid) and placebo (tid) for 14 days Neomycin: 500 mg po bid for 14 days Placebo: placebo for 14 days tid	Group 2 Group 2 will receive neomycin (500 mg po bid) and rifaximin (550mg po tid) for 14 days Neomycin: 500 mg po bid for 14 days Rifaximin: 550 mg po tid
Overall Study STARTED	19	18
Overall Study COMPLETED	16	15
Overall Study NOT COMPLETED	3	3

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Neomycin and Rifaximin Plus Neomycin in Treating Methane Positive Constipation Predominant Irritable Bowel Syndrome

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Group 1 n=16 Participants Group 1 will receive neomycin (500 mg po bid) and placebo (tid) for 14 days Neomycin: 500 mg po bid for 14 days Placebo: placebo for 14 days tid	Group 2 n=15 Participants Group 2 will receive neomycin (500 mg po bid) and rifaximin (550mg po tid) for 14 days Neomycin: 500 mg po bid for 14 days Rifaximin: 550 mg po tid	Total n=31 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	16 Participants n=5 Participants	15 Participants n=7 Participants	31 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	40.4 years STANDARD_DEVIATION 14.3 • n=5 Participants	45.5 years STANDARD_DEVIATION 16.9 • n=7 Participants	42.8 years STANDARD_DEVIATION 15.6 • n=5 Participants
Sex: Female, Male Female	12 Participants n=5 Participants	13 Participants n=7 Participants	25 Participants n=5 Participants
Sex: Female, Male Male	4 Participants n=5 Participants	2 Participants n=7 Participants	6 Participants n=5 Participants
Region of Enrollment United States	16 participants n=5 Participants	15 participants n=7 Participants	31 participants n=5 Participants

PRIMARY outcome

Timeframe: 1 year

Visual analog scale (VAS) score for constipation: Severity was rated using a VAS from 0 to 100 units (with 0 = no symptom and 100 = severe symptoms).

Outcome measures

Outcome measures
Measure	Group 1 n=16 Participants Group 1 will receive neomycin (500 mg po bid) and placebo (tid) for 14 days Neomycin: 500 mg po bid for 14 days Placebo: placebo for 14 days tid	Group 2 n=15 Participants Group 2 will receive neomycin (500 mg po bid) and rifaximin (550mg po tid) for 14 days Neomycin: 500 mg po bid for 14 days Rifaximin: 550 mg po tid
Severity of Constipation in Each Arm at Week 1 After Completion of Therapy	61.2 units on a scale Standard Deviation 24.1	28.6 units on a scale Standard Deviation 30.8

SECONDARY outcome

Timeframe: Baseline (Day 0) and Final Visit (Day 44)

Population: Change in breath test methane gas levels: baseline breath test minus final breath test measurement.

Methane output was reported as methane in parts per million (ppm) on breath test: Subjects fast for 12 h prior to a breath sample. Breath samples were collected via a Quintron dual bag collecting system and analyzed using a BreathTracker SC. Output was reported as methane in parts per million (ppm) after correction for alveolar sample quality using breath CO2 concentration.

Outcome measures

Outcome measures
Measure	Group 1 n=16 Participants Group 1 will receive neomycin (500 mg po bid) and placebo (tid) for 14 days Neomycin: 500 mg po bid for 14 days Placebo: placebo for 14 days tid	Group 2 n=15 Participants Group 2 will receive neomycin (500 mg po bid) and rifaximin (550mg po tid) for 14 days Neomycin: 500 mg po bid for 14 days Rifaximin: 550 mg po tid
Change in Methane From Baseline	7.5 parts per million Standard Deviation 9.739557195	15 parts per million Standard Deviation 24.81324182

Adverse Events

Group 1

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Group 2

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Group 1 n=16 participants at risk Group 1 will receive neomycin (500 mg po bid) and placebo (tid) for 14 days Neomycin: 500 mg po bid for 14 days Placebo: placebo for 14 days tid	Group 2 n=15 participants at risk Group 2 will receive neomycin (500 mg po bid) and rifaximin (550mg po tid) for 14 days Neomycin: 500 mg po bid for 14 days Rifaximin: 550 mg po tid
Ear and labyrinth disorders Tinnitus	6.2% 1/16 • Number of events 1 • Immediately	0.00% 0/15 • Immediately
General disorders Unwell	0.00% 0/16 • Immediately	6.7% 1/15 • Number of events 1 • Immediately

Additional Information

Mark Pimentel

Cedars-Sinai Medical Center

Phone: 3104233792

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place