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

This study has been completed.
Sponsor:
Collaborator:
BioBalance Corporation
Information provided by:
Weill Medical College of Cornell University
ClinicalTrials.gov Identifier:
NCT00194922
First received: September 12, 2005
Last updated: April 3, 2008
Last verified: April 2008
  Purpose

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).


Condition Intervention Phase
Irritable Bowel Syndrome (IBS)
Dietary Supplement: E. Coli Strain M17 Probiotic
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
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)

Resource links provided by NLM:


Further study details as provided by Weill Medical College of Cornell University:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Changes in stool consistency, stool frequency, and bloating [ Time Frame: At the completion of the study ] [ Designated as safety issue: No ]

Enrollment: 35
Study Start Date: August 2004
Study Completion Date: November 2006
Primary Completion Date: November 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: A Dietary Supplement: E. Coli Strain M17 Probiotic
30 ml PO BID for 12 weeks
Other Name: ProBactrix

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).

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00194922

Locations
United States, New York
Cornell Weill Medical College
New York City, New York, United States, 10021
Sponsors and Collaborators
Weill Medical College of Cornell University
BioBalance Corporation
Investigators
Principal Investigator: Christine Frissora, MD Weill Medical College of Cornell University
Principal Investigator: Mark B Pochapin, MD Weill Medical College of Cornell University
  More Information

No publications provided

Responsible Party: Robert Hoerr, The BioBalance Corporation
ClinicalTrials.gov Identifier: NCT00194922     History of Changes
Other Study ID Numbers: BB-03-02003
Study First Received: September 12, 2005
Last Updated: April 3, 2008
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Irritable Bowel Syndrome
Syndrome
Colonic Diseases
Colonic Diseases, Functional
Digestive System Diseases
Disease
Gastrointestinal Diseases
Intestinal Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on November 25, 2014