Effects of Probiotics in Patients With Ulcerative Colitis
Withdrawn before enrolling · Phase 1 · Has a placebo group
Conditions studied: Ulcerative Colitis
In brief
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.
Key facts
- Study ID
- NCT00578799
- Run by
- University of California, Irvine
- People needed
- 0
- Starts
- 2007-12-01
- Expected to finish
- 2007-12-01
- Last updated by the study team
- 2021-01-25
Who can join
Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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; and
- have at least a 2 week history of active UC that has not responded to mesalamine therapy.
- Subjects will not have consumed any fermented products, such as yogurt, for at least 6 weeks prior to being entered into the trial.
You may not qualify if…
- 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.
Where it is running
- University of California, Irvine, Health Sciences Medical Center — Orange, California, United States
Full record on ClinicalTrials.gov
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