Irritable Bowel Syndrome Clinical Trial
Official title:
The Effect of Kyo-Dophilus 1.5 Billion on the Symptoms of Severe Irritable Bowel Syndrome
The Canadian College of Naturopathic Medicine is conducting a research study on Irritable
Bowel Syndrome (IBS), a common condition in North America. It is a long term, recurring
gastrointestinal disorder that is estimated to affect 30% of the general population. IBS is
characterized by abdominal pain and cramps, and bowel dysfunction such as diarrhea and
bloating.
The medicines that are currently used to help people with IBS are not as effective as we
would like them to be. These medicines are usually only prescribed to reduce the pain of IBS
and not actually treat the disorder itself. Recently, scientists have found that probiotics
(beneficial bacteria that live inside humans) may help reduce the painful symptoms and
diarrhea that are part of IBS.
This research is being conducted to determine whether this particular combination of three
probiotic bacteria (named Lactobacillus gasseri, Bifidobacterium bifidum and Bifidobacterium
longum) will reduce the symptoms of severe IBS.
The purpose of this trial is to investigate the effects of the three strain probiotic,
Kyo-Dophilus, on the symptoms associated with severe Irritable Bowel Syndrome. A previous
pilot clinical trial identified individuals with severe IBS to be most likely to benefit
from the treatment provided in this trial.
The primary objective of this trial is to determine the effectiveness of Kyo-Dophilus on the
symptoms associated with Irritable Bowel Syndrome in an adult population diagnosed with
Irritable Bowel Syndrome by ROME III criteria and classified as severe through the Irritable
Bowel Severity Scoring System and to measure quality of life and global well-being of
patients through the Adequate Relief Criteria and the Irritable Bowel Syndrome-Quality of
Life Questionnaire.
The secondary objective is to assess the tolerability of the treatment through the use of
Adverse Event Reporting Forms.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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