NCT00945334

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
37

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2009

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 23, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 24, 2009

Completed
8 days until next milestone

Study Start

First participant enrolled

August 1, 2009

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2013

Completed
2.2 years until next milestone

Results Posted

Study results publicly available

August 10, 2015

Completed
Last Updated

August 10, 2015

Status Verified

July 1, 2015

Enrollment Period

3.8 years

First QC Date

July 23, 2009

Results QC Date

February 25, 2015

Last Update Submit

July 17, 2015

Conditions

Constipation-predominant Irritable Bowel Syndrome

Keywords

Constipation predominant Irritable Bowel Syndrome

Outcome Measures

Primary Outcomes (1)

  • 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).

    1 year

Secondary Outcomes (1)

  • Change in Methane From Baseline

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

Study Arms (2)

Group 1

EXPERIMENTAL

Group 1 will receive neomycin (500 mg po bid) and placebo (tid) for 14 days

Drug: NeomycinDrug: Placebo

Group 2

EXPERIMENTAL

Group 2 will receive neomycin (500 mg po bid) and rifaximin (550mg po tid) for 14 days

Drug: NeomycinDrug: Rifaximin

Interventions

NeomycinDRUG

500 mg po bid for 14 days

Also known as: Mycifradin, Neo-Tab, Neo-Fradin
Group 1Group 2
PlaceboDRUG

placebo for 14 days tid

Group 1
RifaximinDRUG

550 mg po tid

Also known as: Xifaxan
Group 2

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Cedars-Sinai Medical Center

Los Angeles, California, 90048, United States

Location

Georgia Health Sciences University

Augusta, Georgia, 30912, United States

Location

Related Publications (2)

  • 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.

    PMID: 17043337BACKGROUND

  • Pimentel 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.

    PMID: 16832617BACKGROUND

MeSH Terms

Interventions

NeomycinRifaximin

Intervention Hierarchy (Ancestors)

AminoglycosidesGlycosidesCarbohydratesRifamycinsHeterocyclic Compounds, 4 or More RingsHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsLactams, MacrocyclicMacrocyclic CompoundsPolycyclic Compounds

Results Point of Contact

Title
Mark Pimentel
Organization
Cedars-Sinai Medical Center
chuak@cshs.org
3104233792

Study Officials

  • Mark Pimentel, MD, FRCP(C)

    Cedars-Sinai Medical Center

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Director, GI Motility Program

Study Record Dates

First Submitted

July 23, 2009

First Posted

July 24, 2009

Study Start

August 1, 2009

Primary Completion

June 1, 2013

Study Completion

June 1, 2013

Last Updated

August 10, 2015

Results First Posted

August 10, 2015

Record last verified: 2015-07

Locations

US(2)