Effects of Probiotics in Patients With Ulcerative Colitis
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.
|Ulcerative Colitis||Dietary Supplement: Kyo-Dophilus Dietary Supplement: placebo||Phase 1|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Investigator)
Primary Purpose: Treatment
|Official Title:||Effects of Probiotics in Patients With Ulcerative Colitis.|
- 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 ]
|Study Start Date:||July 2008|
|Estimated Study Completion Date:||January 2010|
|Estimated Primary Completion Date:||January 2010 (Final data collection date for primary outcome measure)|
Active Comparator: Kyo-Dophilus
Kyo-Dophilus (5x109 bacteria/capsule, twice a day, 1 in the morning, 1 in the evening)
Dietary Supplement: Kyo-Dophilus
5x109 bacteria/capsule, twice a day, 1 in the morning, 1 in the evening
Placebo Comparator: Placebo
placebo capsules (potato starch)
Dietary Supplement: placebo
placebo capsules (potato starch
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 assessment and analysis of inflammatory cytokine production (mRNA). Also, 30 ml of venous blood will be collected from each subject for analysis of serum/plasma levels of inflammatory cytokines and stress hormones. Subjects will be randomly assigned to the probiotic or placebo group (blinded to the physicians). After consuming the dietary supplement or placebo for 6 weeks, subjects will complete the SIBDQ questionnaire, the physician complete the UCDAI, be examined by sigmoidoscopy and tissue biopsies and blood samples collected. Also, during the 6 weeks of treatment, subjects will maintain a daily diary of their bowel habits. Data analysis will determine whether, relative to placebo controls, consumption of probiotics reduces the symptoms and levels of intestinal inflammation in patients with ulcerative colitis.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00578799
|United States, California|
|University of California, Irvine, Health Sciences Medical Center|
|Orange, California, United States, 92868|
|Principal Investigator:||Dwight M Nance, Ph.D||University of California, Irvine|