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Study to Determine the Effectiveness of the Probiotic E. Coli Strain M17 in Treating Irritable Bowel Syndrome (IBS)

Primary Purpose

Irritable Bowel Syndrome (IBS)

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
E. Coli Strain M17 Probiotic
Sponsored by
Weill Medical College of Cornell University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Irritable Bowel Syndrome (IBS)

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Age =18 or =80, males and females. Diagnosed with IBS by Rome II criteria , also called "bloating" Normal colonic anatomy in the past 5 years as evidenced by a colonoscopy, flex sigmoidoscopy, Barium enema, Sonography, or other exam deemed acceptable by the study physician Normal thyroid function tests (or compensated on thyroid replacement) and negative antibody screening test for celiac disease. Normal blood chemistries and CBC for age, sex measured within 6 months of starting study. Exclusion Criteria: Pregnant, breast-feeding, or not using approved methods of contraception (if of childbearing potential) Unstable medical disorder or other GI disorder (per discretion of screening physician), especially Crohn's disease, history of carcinomas of the bowel, malabsorption syndrome, intolerance to certain food types (such as lactose), functional diarrhea, and functional constipation Patient has undergone MAJOR abdominal surgery in the past (note: an appendectomy, for example, is not included in this definition. Patient has had E. coli strain M17 administered in the past six months History of major psychiatric disorder or substance abuse within the previous 2 years, including psychiatric illnesses requiring medication that may cause doubt in the validity of the signed Informed Consent form -- Existing illness or medical condition that will prevent the patient from participating in the study (such as severe heart disease, insulin dependent diabetes, hyperactive thyroid gland, HIV positive, anemia, etc.) Participation in another clinical study during the past four weeks. Candidate will not be available for the next 18 weeks (2 weeks run-in, 12 weeks study, 4 weeks follow-up) Recent abnormal values in any routine lab tests prior to beginning the trial product, with values deviating from normal in either direction by a factor of 2.5, unless follow up test has been shown to be normal. Elevated liver function tests: aspartate aminotransferase or alanine aminotransferase >2.5 times upper limit of normal. Elevated renal function test: serum creatinine > 152.4 mmol/L (or appropriate upper cutoff per lab. Abnormal CBC indicating anemia by age and sex standards. Abnormal urinalysis (evidence of infection or albumin). Hyperthyroidism or hypothyroidism: T4 or TSH greater than or less than normal range. If previously diagnosed, disease must be managed and stable. Positive antibody test for celiac disease. Non-skin malignancy in previous 5 years Any use of an investigational drug within 30 days of screening period Any use of a probiotic supplement within 30 days of the screening period (with the exception of standard food yogurt products) Any use of antibiotics within 42 days of the screening period (however, candidate may wait to initiate screening exam until 42 days have lapsed since antibiotic course was completed) Current use of any drugs or treatments which the study physician believes has caused gastrointestinal symptoms that may be confused with or add to the symptoms of IBS.

Sites / Locations

  • Cornell Weill Medical College

Arms of the Study

Arm 1

Arm Type

Placebo Comparator

Arm Label

A

Arm Description

Outcomes

Primary Outcome Measures

Relief of pain and discomfort for at least 2 weeks per month over a 12 week period

Secondary Outcome Measures

Changes in stool consistency, stool frequency, and bloating

Full Information

First Posted
September 12, 2005
Last Updated
April 3, 2008
Sponsor
Weill Medical College of Cornell University
Collaborators
BioBalance Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT00194922
Brief Title
Study to Determine the Effectiveness of the Probiotic E. Coli Strain M17 in Treating Irritable Bowel Syndrome (IBS)
Official Title
A Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study of the Tolerance and Efficacy of the Probiotic E. Coli Strain M17 on Symptoms and Quality of Life in Individuals With Irritable Bowel Syndrome (IBS)
Study Type
Interventional

2. Study Status

Record Verification Date
April 2008
Overall Recruitment Status
Completed
Study Start Date
August 2004 (undefined)
Primary Completion Date
November 2006 (Actual)
Study Completion Date
November 2006 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Weill Medical College of Cornell University
Collaborators
BioBalance Corporation

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this study is to determine the tolerance and efficacy of the probiotic E. Coli Strain M17 on symptoms and Quality of Life in Individuals with Irritable Bowel Syndrome (IBS).
Detailed Description
IBS is characterized by abdominal discomfort and altered bowel function, without identifiable structural or biochemical abnormalities. Current management approaches are not satisfactory for many individuals, who continue to have intermittent constipation or diarrhea, associated with abdominal discomfort. Probiotics, or "friendly bacteria", is the name given to a new category of products that show promise for managing the symptoms of IBS. In the intestine they are believed to compete with other bacteria, to product substances that interfere with other bacteria, and to improve the function of the mucous lining and immune function of the gastrointestinal tract. A common source of probiotics is in cultured dairy products,m such as yogurt or cheese. E. coli Strain M17 is not regulated vy the Food and Drug Administration. It is considered to be a health food supplement. E. coli strain M17 was identified in Russia more than 70 years ago. It became widely used in countries of the former Soviet Union for a variety of gastrointestinal problems, including IBS, inflammatory bowel disease (ulcerative colitis or Crohn's disease), and diarrhea, including infants and children. It continues to be produced and marketed under government control in the Russian Federation. E. coli strain M17 was brought to Israel in the early 1990's by two Russian scientists. It was developed for human use and animal feed and approved for use by the Israeli health authorities. A special liquid formulation was developed and sold as a nutritional supplement in pharmacies in Israel until 2002 when the product was acquired by a U.S. company, the BioBalance Corporation, for the purpose of introducing it outside Israel as a medical food and nutritional supplement in the U.S. and other countries. The purpose of this research study is to compare the tolerability and effectiveness of E. coli strain M17 to placebo in the treatment of Irritable Bowel Syndrome (IBS).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Irritable Bowel Syndrome (IBS)

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
35 (Actual)

8. Arms, Groups, and Interventions

Arm Title
A
Arm Type
Placebo Comparator
Intervention Type
Dietary Supplement
Intervention Name(s)
E. Coli Strain M17 Probiotic
Other Intervention Name(s)
ProBactrix
Intervention Description
30 ml PO BID for 12 weeks
Primary Outcome Measure Information:
Title
Relief of pain and discomfort for at least 2 weeks per month over a 12 week period
Time Frame
at the completion of the study
Secondary Outcome Measure Information:
Title
Changes in stool consistency, stool frequency, and bloating
Time Frame
At the completion of the study

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age =18 or =80, males and females. Diagnosed with IBS by Rome II criteria , also called "bloating" Normal colonic anatomy in the past 5 years as evidenced by a colonoscopy, flex sigmoidoscopy, Barium enema, Sonography, or other exam deemed acceptable by the study physician Normal thyroid function tests (or compensated on thyroid replacement) and negative antibody screening test for celiac disease. Normal blood chemistries and CBC for age, sex measured within 6 months of starting study. Exclusion Criteria: Pregnant, breast-feeding, or not using approved methods of contraception (if of childbearing potential) Unstable medical disorder or other GI disorder (per discretion of screening physician), especially Crohn's disease, history of carcinomas of the bowel, malabsorption syndrome, intolerance to certain food types (such as lactose), functional diarrhea, and functional constipation Patient has undergone MAJOR abdominal surgery in the past (note: an appendectomy, for example, is not included in this definition. Patient has had E. coli strain M17 administered in the past six months History of major psychiatric disorder or substance abuse within the previous 2 years, including psychiatric illnesses requiring medication that may cause doubt in the validity of the signed Informed Consent form -- Existing illness or medical condition that will prevent the patient from participating in the study (such as severe heart disease, insulin dependent diabetes, hyperactive thyroid gland, HIV positive, anemia, etc.) Participation in another clinical study during the past four weeks. Candidate will not be available for the next 18 weeks (2 weeks run-in, 12 weeks study, 4 weeks follow-up) Recent abnormal values in any routine lab tests prior to beginning the trial product, with values deviating from normal in either direction by a factor of 2.5, unless follow up test has been shown to be normal. Elevated liver function tests: aspartate aminotransferase or alanine aminotransferase >2.5 times upper limit of normal. Elevated renal function test: serum creatinine > 152.4 mmol/L (or appropriate upper cutoff per lab. Abnormal CBC indicating anemia by age and sex standards. Abnormal urinalysis (evidence of infection or albumin). Hyperthyroidism or hypothyroidism: T4 or TSH greater than or less than normal range. If previously diagnosed, disease must be managed and stable. Positive antibody test for celiac disease. Non-skin malignancy in previous 5 years Any use of an investigational drug within 30 days of screening period Any use of a probiotic supplement within 30 days of the screening period (with the exception of standard food yogurt products) Any use of antibiotics within 42 days of the screening period (however, candidate may wait to initiate screening exam until 42 days have lapsed since antibiotic course was completed) Current use of any drugs or treatments which the study physician believes has caused gastrointestinal symptoms that may be confused with or add to the symptoms of IBS.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christine Frissora, MD
Organizational Affiliation
Weill Medical College of Cornell University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Mark B Pochapin, MD
Organizational Affiliation
Weill Medical College of Cornell University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cornell Weill Medical College
City
New York City
State/Province
New York
ZIP/Postal Code
10021
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Study to Determine the Effectiveness of the Probiotic E. Coli Strain M17 in Treating Irritable Bowel Syndrome (IBS)

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