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

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ClinicalTrials.gov Identifier: NCT00194922
Recruitment Status : Completed
First Posted : September 19, 2005
Last Update Posted : April 4, 2008
Sponsor:
Collaborator:
BioBalance Corporation
Information provided by:
Weill Medical College of Cornell University

Tracking Information
First Submitted Date  ICMJE September 12, 2005
First Posted Date  ICMJE September 19, 2005
Last Update Posted Date April 4, 2008
Study Start Date  ICMJE August 2004
Actual Primary Completion Date November 2006   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 3, 2008)
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 ]
Original Primary Outcome Measures  ICMJE
 (submitted: September 12, 2005)
 To determine whether consumption of E. coli strain M17 beverage improves the abdominal discomfort and altered bowel function experienced by individuals with IBS
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 3, 2008)
Changes in stool consistency, stool frequency, and bloating [ Time Frame: At the completion of the study ]
Original Secondary Outcome Measures  ICMJE
 (submitted: September 12, 2005)
  •  To study the effect of E. coli strain M17 beverage on stool consistency, sense of urgency, stool frequency
  •  To study the effect of E. coli strain M17 beverage on the quality of life
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study to Determine the Effectiveness of the Probiotic E. Coli Strain M17 in Treating Irritable Bowel Syndrome (IBS)
Official Title  ICMJE 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)
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).

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Irritable Bowel Syndrome (IBS)
Intervention  ICMJE Dietary Supplement: E. Coli Strain M17 Probiotic
30 ml PO BID for 12 weeks
Other Name: ProBactrix
Study Arms  ICMJE Placebo Comparator: A
Intervention: Dietary Supplement: E. Coli Strain M17 Probiotic
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 3, 2008)
35
Original Enrollment  ICMJE
 (submitted: September 12, 2005)
70
Actual Study Completion Date  ICMJE November 2006
Actual Primary Completion Date November 2006   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00194922
Other Study ID Numbers  ICMJE BB-03-02003
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Robert Hoerr, The BioBalance Corporation
Study Sponsor  ICMJE Weill Medical College of Cornell University
Collaborators  ICMJE BioBalance Corporation
Investigators  ICMJE
Principal Investigator: Christine Frissora, MD Weill Medical College of Cornell University
Principal Investigator: Mark B Pochapin, MD Weill Medical College of Cornell University
PRS Account Weill Medical College of Cornell University
Verification Date April 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP