Constipation-predominant Irritable Bowel SyndromeC-IBSNCT00945334
Neomycin and Rifaximin Plus Neomycin in Treating Methane Positive Constipation Predominant Irritable Bowel Syndrome
A study testing Neomycin and Rifaximin in people with Constipation-predominant Irritable Bowel Syndrome, run by Mark Pimentel, MD at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Constipation-predominant Irritable Bowel Syndrome
- What is being tested?
- Neomycin and Rifaximin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 37 participants
- Where
- 2 sitesUnited States
- Study dates
- Aug 2009to Jun 2013
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 12Show fewer
- Subjects with hearing loss and/or tinnitus
- History of bowel obstruction
- History of celiac disease
- History of inflammatory bowel disease
- Cirrhosis
- Diabetes
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Georgia Health Sciences University
Augusta, Georgia, 30912
Cedars-Sinai Medical Center
Los Angeles, California, 90048
About this study
Official title: Double-blind, Placebo Controlled Trial Comparing Neomycin to Rifaximin Plus Neomycin in the Treatment of Methane Positive Subjects With Constipation-predominant Irritable Bowel Syndrome
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.
- Being tested
- Neomycin, Placebo, Rifaximin
- Keywords
- Constipation predominant Irritable Bowel Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NeomycinDrug
Also called Mycifradin, Neo-Tab, Neo-Fradin
500 mg po bid for 14 days
PlaceboDrug
placebo for 14 days tid
RifaximinDrug
Also called Xifaxan
550 mg po tid
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | Group 1 will receive neomycin (500 mg po bid) and placebo (tid) for 14 days Receives: Drug: Neomycin; Drug: Placebo |
| Group 2 | Experimental | Group 2 will receive neomycin (500 mg po bid) and rifaximin (550mg po tid) for 14 days Receives: Drug: Neomycin; Drug: Rifaximin |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 1 year
Secondary outcomes (1)
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.
Measured: Baseline (Day 0) and Final Visit (Day 44)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2009 (estimated)
- Study startAug 2009
- Primary completionJun 2013
- Study completionJun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Constipation-predominant Irritable Bowel SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mark Pimentel, MD
- Sponsor type
- University, hospital or other
- Collaborators
- Bausch Health Americas, Inc.
- Responsible party
- Sponsor-investigator, Mark Pimentel, MD, Cedars-Sinai Medical Center
- Investigators
- Mark Pimentel, MD, FRCP(C), Principal investigator, Cedars-Sinai Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00945334
- Sponsor's protocol ID
- 18709
- Acronym
- C-IBS
- Status last verified
- Jul 2015
- First submitted
- 23 Jul 2009
- Last updated
- 10 Aug 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Pimentel M, Park S, Mirocha J, Kane SV, Kong Y. The effect of a nonabsorbed oral antibiotic (rifaximin) on the symptoms of the irritable bowel syndrome: a randomized trial. Ann Intern Med. 2006 Oct 17;145(8):557-63. doi: 10.7326/0003-4819-145-8-200610170-00004.
PubMed 17043337Pimentel M, Chatterjee S, Chow EJ, Park S, Kong Y. Neomycin improves constipation-predominant irritable bowel syndrome in a fashion that is dependent on the presence of methane gas: subanalysis of a double-blind randomized controlled study. Dig Dis Sci. 2006 Aug;51(8):1297-301. doi: 10.1007/s10620-006-9104-6. Epub 2006 Jul 11.
PubMed 16832617
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Double-blind, Placebo Controlled Trial Comparing Neomycin to Rifaximin Plus Neomycin in the Treatment of Methane Positive Subjects With Constipation-predominant Irritable Bowel Syndrome
- ClinicalTrials.gov ID
- NCT00945334
- Acronym / sponsor ID
- C-IBS / 18709
- Keywords
- Constipation predominant Irritable Bowel Syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- Mark Pimentel, MDUniversity, hospital or other
- Collaborators
- Bausch Health Americas, Inc.
- Study start
- Aug 2009
- Primary completion
- Jun 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 24 Jul 2009 (estimated)
- Results
- Posted 10 Aug 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Drug: Neomycin, Drug: PlaceboGroup 1 will receive neomycin (500 mg po bid) and placebo (tid) for 14 days |
| Group 2 | Experimental | Drug: Neomycin, Drug: RifaximinGroup 2 will receive neomycin (500 mg po bid) and rifaximin (550mg po tid) for 14 days |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NeomycinAlso: Mycifradin, Neo-Tab, Neo-Fradin500 mg po bid for 14 days | Drug | Group 1, Group 2 |
| Placeboplacebo for 14 days tid | Drug | Group 1 |
| RifaximinAlso: Xifaxan550 mg po tid | Drug | Group 2 |
Primary outcome
Severity of Constipation in Each Arm at Week 1 After Completion of Therapy
Time frame: 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).
1 secondary outcome
Change in Methane From Baseline
Time frame: Baseline (Day 0) and Final Visit (Day 44)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 17043337Pimentel M, Park S, Mirocha J, Kane SV, Kong Y. The effect of a nonabsorbed oral antibiotic (rifaximin) on the symptoms of the irritable bowel syndrome: a randomized trial. Ann Intern Med. 2006 Oct 17;145(8):557-63. doi: 10.7326/0003-4819-145-8-200610170-00004.
- Background: PubMed 16832617Pimentel M, Chatterjee S, Chow EJ, Park S, Kong Y. Neomycin improves constipation-predominant irritable bowel syndrome in a fashion that is dependent on the presence of methane gas: subanalysis of a double-blind randomized controlled study. Dig Dis Sci. 2006 Aug;51(8):1297-301. doi: 10.1007/s10620-006-9104-6. Epub 2006 Jul 11.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mark Pimentel, MD, FRCP(C) principal investigator
Cedars-Sinai Medical Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Neomycin and Rifaximin in people with Constipation-predominant Irritable Bowel Syndrome, run by Mark Pimentel, MD at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 10 Aug 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Severity of Constipation in Each Arm at Week 1 After Completion of Therapy (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00945334, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Aug 2015.