Ignite Creation Date:
2024-05-05 @ 11:57 AM
Last Modification Date:
2024-10-26 @ 9:17 AM
Study NCT ID:
NCT00194922
Status:
COMPLETED
Last Update Posted:
2008-04-04
First Post:
2005-09-12
Brief Title:
Study to Determine the Effectiveness of the Probiotic E Coli Strain M17 in Treating Irritable Bowel Syndrome IBS
Sponsor:
Weill Medical College of Cornell University
Organization:
Weill Medical College of Cornell University
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2008-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 productsm 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 Crohns 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 1990s 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 US company the BioBalance Corporation for the purpose of introducing it outside Israel as a medical food and nutritional supplement in the US 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
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 productsm 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 Crohns 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 1990s 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 US company the BioBalance Corporation for the purpose of introducing it outside Israel as a medical food and nutritional supplement in the US 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None