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.
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.
- We will be studying patients with mild to moderate active ulcerative colitis (UC).
- Patients are eligible to participate if:
- they are between 18 and 65 yr of age;
- have an endoscopic and histologic confirmed diagnosis of UC for at least 1 yr;
- have at least a 2 week history of active UC that has not responded to mesalamine
- Subjects will not have consumed any fermented products, such as yogurt, for at least
6 weeks prior to being entered into the trial.
- Subjects will be excluded if they have the following:
- Crohn's disease,
- disease less than 25 cm from the anal canal,
- active enteric infection,
- evidence of severe disease characterized by hemoglobin <8.0 g/dl, white blood
cell count >20,000 cells/mm3, temperature >38.5◦C, albumin <25 g/dl, active
disease >2 months, UCDAI < 2 or >9,
- history of dysplasia of the colon or any cancer within 5 years,
- clinically significant hematologic values (see above) or biochemical values
(serum creatinine concentrations >1.5 times the upper limit of normal or
alkaline phosphatase, aspartate aminotransferase, or alanine aminotransferase
concentrations >2.5 times the upper limit of normal) are also ineligible.