Constipation-predominant Irritable Bowel Syndrome
Conditions
Keywords
Constipation predominant Irritable Bowel Syndrome
Brief summary
In this study the investigators aim to compare the efficacy of neomycin to a combination of rifaximin and neomycin in the treatment of C-IBS subjects with methane on their breath test. This study will be conducted in collaboration with Dr. John DiBaise at the Mayo Clinic in Scottsdale, AZ and Dr. Satish Rao in Georgia Regents University in Augusta, GA.
Interventions
Sponsors
Mark Pimentel, MD
Bausch Health Americas, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Rome III positive IBS subjects (18-75 years of age) * Meet criteria for constipation predominant IBS symptoms including ≤ 3 complete spontaneous bowel movements per week with hard or lumpy stools. * Presence of detectable methane on single breath sample (≥ 3ppm). * If subjects are ≥ 50 years old, a colonoscopy had to have been completed within the past 5 years.
Exclusion criteria
* Subjects with history of intestinal surgery (except appendectomy or cholecystectomy) * Recent antibiotic use (within the last 30 days) * Subjects with known pelvic floor dysfunction * Pregnancy * Creatinine level \> 1.4 * Poorly controlled/uncontrolled significant medical condition that would interfere with study procedures * Subjects with hearing loss and/or tinnitus * History of bowel obstruction * History of celiac disease * History of inflammatory bowel disease * Cirrhosis * Diabetes
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Severity of Constipation in Each Arm at Week 1 After Completion of Therapy | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Methane From Baseline | Baseline (Day 0) and Final Visit (Day 44) | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 16 |
| 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 | 15 |
| Total | 31 |
Baseline characteristics
| Characteristic | Group 2 | Group 1 | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 15 Participants | 16 Participants | 31 Participants |
| Age, Continuous | 45.5 years STANDARD_DEVIATION 16.9 | 40.4 years STANDARD_DEVIATION 14.3 | 42.8 years STANDARD_DEVIATION 15.6 |
| Region of Enrollment United States | 15 participants | 16 participants | 31 participants |
| Sex: Female, Male Female | 13 Participants | 12 Participants | 25 Participants |
| Sex: Female, Male Male | 2 Participants | 4 Participants | 6 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 1 / 16 | 1 / 15 |
| serious Total, serious adverse events | 0 / 16 | 0 / 15 |
Outcome results
Primary
Severity of Constipation in Each Arm at Week 1 After Completion of Therapy
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).
Time frame: 1 year
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group 1 | Severity of Constipation in Each Arm at Week 1 After Completion of Therapy | 61.2 units on a scale | Standard Deviation 24.1 |
| Group 2 | Severity of Constipation in Each Arm at Week 1 After Completion of Therapy | 28.6 units on a scale | Standard Deviation 30.8 |
Secondary
Change in Methane From Baseline
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.
Time frame: Baseline (Day 0) and Final Visit (Day 44)
Population: Change in breath test methane gas levels: baseline breath test minus final breath test measurement.
| Arm | Measure | Value (MEDIAN) | Dispersion |
|---|---|---|---|
| Group 1 | Change in Methane From Baseline | 7.5 parts per million | Standard Deviation 9.739557195 |
| Group 2 | Change in Methane From Baseline | 15 parts per million | Standard Deviation 24.81324182 |