Clinical Trial: Effects of Probiotics in Patients With Ulcerative Colitis

Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional

Official Title: Effects of Probiotics in Patients With Ulcerative Colitis.

Brief Summary:

This study is being conducted in patients who have been diagnosed with ulcerative colitis (UC), a form of inflammatory bowel disease (IBD) - a disease of the intestine.

The purpose of this study is to test the therapeutic (medical treatment) effects of daily consumption of Kyo-Dophilus (a commercially available dietary supplement often used by individuals with inflammatory bowel disease) on their UC. Kyo-Dophilus consists of three probiotic bacteria (beneficial bacteria to help maintain the balance of good bacteria in the intestine) to help treat inflammatory bowel disease caused by bad bacteria. Patients will still be maintained on their clinical standard of care for their UC as part of their participation in this study.


Detailed Summary:

Probiotics are defined as "live microorganisms, which, when administered in adequate amounts, confer a health benefit on the host." Most probiotics are lactic acid producing bacteria that are endogenous to the human GI (gastrointestinal) tract and are commonly utilized in the fermentation of food products, such as yogurt. Disturbances in the composition of the bacterial flora of the GI tract are associated with diarrhea and inflammatory bowel disease (IBD), and consumption of some strains of probiotic bacteria are very effective for treating diarrhea and possibly individuals with ulcerative colitis (UC). We will test the effects of 3 strains of probiotic bacteria on UC. In addition to standard medical care for UC, participants will consume a dietary supplement of 3 probiotic bacteria (Kyo-Dophilus; Lacobacillus acidophilus, Bifidobacterium bifidum, and Bifidobacterium longum) for 6 weeks. Changes in clinical symptoms and physiological markers of systemic and GI inflammation in subjects with UC will be assessed. Significant effects of the probiotics will be determined by comparing pre- and post-probiotic treatment measures for disease severity and level of inflammation and by comparing the probiotic treated group with the placebo treated control group. Any placebo effect on UC will also be assessed.

Forty subjects with ulcerative colitis will be recruited for the study and be provided a dietary supplement (5x109 bacteria/capsule, twice a day) for 6 weeks to 1/2 of the subjects and 1/2 of the UC subjects will be given a placebo control (potato starch). Standard medical care and therapies will be continued throughout the study. Initially, the physician will complete the Ulcerative Colitis Disease Activity Index (UCDAI) and the participants will complete the Shortened Inflammatory Bowel Disease Questionnaire (SIBDQ), and biopsies collected for histopathological asse
Sponsor: University of California, Irvine

Current Primary Outcome:

  • The UCDAI (Ulcerative Colitis Disease Activity Index) scores will be used to measure disease remission [ Time Frame: 2 years ]
  • Results of patient questionnaires. [ Time Frame: 2 years ]
  • Histopathological scoring of disease activity [ Time Frame: 2 years ]


Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: University of California, Irvine

Dates:
Date Received: December 18, 2007
Date Started: July 2008
Date Completion: January 2010
Last Updated: July 1, 2009
Last Verified: July 2009