Status:
WITHDRAWN
Lactobacillus GG in Pediatric Ulcerative Colitis (UC)
Lead Sponsor:
Children's Hospital Medical Center, Cincinnati
Conditions:
Ulcerative Colitis
Eligibility:
All Genders
5-18 years
Phase:
PHASE2
Brief Summary
Abstract: Current evidence suggests that the enteric flora is the primary trigger for chronic mucosal inflammation in the Inflammatory Bowel Diseases (IBD), Crohn's Disease (CD) and Ulcerative Coliti...
Eligibility Criteria
Inclusion
- Ability to provide written informed consent (and if applicable, Assent) and comply with study assessments for the full duration of the study;
- Enrolled without regard to gender, race, ethnicity;
- Age \> 5 years to \< 18 years;
- Diagnosis of Ulcerative Colitis (UC);
- Remission or mild disease activity defined by a PUCAI \<34;
- Subjects taking stable doses (defined as 30 days) of all UC medications including AZA/6-MP, methotrexate, mesalamine, or infliximab at entry will be included;
- Willing to use birth control during study participation for females of child-bearing potential, as determined by investigator.
Exclusion
- Current use, or use in the last 3 months, of probiotic preparations, not including yogurt;
- Known history of HIV or other known immunocompromised disease;
- Any central vascular line;
- Concomitant administration of an antibiotic, and must be off antibiotics for at least one month prior to enrollment;
- Cardiac valvular disease;
- Any other condition requiring current hospitalization for treatment;
- Current use of prednisone or budesonide;
- Diagnosis of Crohn's disease or indeterminate colitis;
- Pregnancy (positive pregnancy test) prior to enrollment in the study for females of child-bearing potential;
- Females of child-bearing potential who are unwilling to use birth control during study participation;
- Any other condition that the investigator believes would pose a significant hazard to the subject if the investigational therapy were initiated;
- Participation in another simultaneous clinical trial involving a drug or biological other than participation in the Pediatric IBD Registry and/or the Pediatric IBD Network for Research and Improvement.
Key Trial Info
Start Date :
March 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2012
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00895336
Start Date
March 1 2011
End Date
October 1 2012
Last Update
February 7 2017
Active Locations (1)
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1
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States, 45229