Effects of Probiotics in Patients With Ulcerative Colitis

NCT00578799 | Withdrawn Phase 1 DMC

• 1 other identifier: OCRT07053 [2007-6028]
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Ulcerative Colitis

Keywords

ulcerative colitis

Outcome Measures

Primary Outcomes (3)

• The UCDAI (Ulcerative Colitis Disease Activity Index) scores will be used to measure disease remission

  2 years

• Results of patient questionnaires.

  2 years

• Histopathological scoring of disease activity

  2 years

Study Arms (2)

Kyo-Dophilus

ACTIVE COMPARATOR

Kyo-Dophilus (5x109 bacteria/capsule, twice a day, 1 in the morning, 1 in the evening)

Dietary Supplement: Kyo-Dophilus

Placebo

PLACEBO COMPARATOR

placebo capsules (potato starch)

Dietary Supplement: placebo

Interventions

Kyo-Dophilus DIETARY_SUPPLEMENT

5x109 bacteria/capsule, twice a day, 1 in the morning, 1 in the evening

Kyo-Dophilus

placebo DIETARY_SUPPLEMENT

placebo capsules (potato starch

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• University of California, Irvine: lead
• Wakunaga Pharmaceutical Co., Ltd.: collaborator

Study Sites (1)

University of California, Irvine, Health Sciences Medical Center

Orange, California, 92868, United States

Location

MeSH Terms

Conditions

Colitis, Ulcerative

Condition Hierarchy (Ancestors)

Colitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Inflammatory Bowel Diseases; Colonic Diseases; Intestinal Diseases

Study Officials

• Dwight M Nance, Ph.D

  University of California, Irvine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 18, 2007
• First Posted: December 21, 2007
• Study Start: December 1, 2007
• Primary Completion: December 1, 2007
• Study Completion: December 1, 2007
• Last Updated: January 25, 2021

Record last verified: 2021-01

Locations

US (1)