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Neomycin and Rifaximin Plus Neomycin in Treating Methane Positive Constipation Predominant Irritable Bowel Syndrome (C-IBS)

Primary Purpose

Constipation-predominant Irritable Bowel Syndrome

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Neomycin

Placebo

Rifaximin

About this trial

This is an interventional treatment trial for Constipation-predominant Irritable Bowel Syndrome focused on measuring Constipation predominant Irritable Bowel Syndrome

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Cedars-Sinai Medical Center
Georgia Health Sciences University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Group 1

Group 2

Arm Description

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

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

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

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.

Full Information

NCT ID

NCT00945334

First Posted

July 23, 2009

Last Updated

July 17, 2015

Sponsor

Mark Pimentel, MD

Collaborators

Bausch Health Americas, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT00945334

Brief Title

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

Acronym

C-IBS

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2015

Overall Recruitment Status

Completed

Study Start Date

August 2009 (undefined)

Primary Completion Date

June 2013 (Actual)

Study Completion Date

June 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Mark Pimentel, MD

Collaborators

Bausch Health Americas, Inc.

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Constipation-predominant Irritable Bowel Syndrome

Keywords

Constipation predominant Irritable Bowel Syndrome

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

37 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Group 1

Arm Type

Experimental

Arm Description

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

Arm Title

Group 2

Arm Type

Experimental

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Neomycin

Other Intervention Name(s)

Mycifradin, Neo-Tab, Neo-Fradin

Intervention Description

500 mg po bid for 14 days

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

placebo for 14 days tid

Intervention Type

Drug

Intervention Name(s)

Rifaximin

Other Intervention Name(s)

Xifaxan

Intervention Description

550 mg po tid

Primary Outcome Measure Information:

Title

Severity of Constipation in Each Arm at Week 1 After Completion of Therapy

Description

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

Secondary Outcome Measure Information:

Title

Change in Methane From Baseline

Description

Time Frame

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Mark Pimentel, MD, FRCP(C)

Organizational Affiliation

Cedars-Sinai Medical Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

Cedars-Sinai Medical Center

City

Los Angeles

State/Province

California

ZIP/Postal Code

90048

Country

United States

Facility Name

Georgia Health Sciences University

City

Augusta

State/Province

Georgia

ZIP/Postal Code

30912

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

17043337

Citation

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.

Results Reference

background

PubMed Identifier

16832617

Citation

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.

Results Reference

background

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

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