Lactobacillus GG in Pediatric Ulcerative Colitis (UC)

This study has been withdrawn prior to enrollment.
(IND for this study remained on clinical hold)
Sponsor:
Information provided by:
Children's Hospital Medical Center, Cincinnati
ClinicalTrials.gov Identifier:
NCT00895336
First received: April 27, 2009
Last updated: February 8, 2011
Last verified: February 2011
  Purpose

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 Colitis (UC). Studies using probiotic administration to modify the flora for either induction or maintenance of remission in IBD have had mixed results. Whether probiotics may exert an anti-inflammatory effect in IBD is not known. The investigators hypothesize that daily administration of a probiotic, Lactobacillus GG, for four weeks will reduce objective markers of mucosal inflammation in pediatric UC patients. The investigators will enroll 20 UC patients in remission or with mild disease activity. These patients will have a one month period of observation without intervention. They will then receive Lactobacillus GG (Culturelle), 1010 CFU by mouth twice a day for four weeks (28 days). At baseline and Day 28, and at day 56 clinical disease activity will be measured using the Pediatric UC Activity Index (PUCAI), a blood sample for determination of circulating granulocyte pSTAT3+ activation will be obtained, and a stool sample for determination of fecal calprotectin will be obtained. In addition, =the investigators will sample subject saliva to determine salivary glycan phenotype as a surrogate marker of changes of mucosal glycan expression in response to probiotic administration. The investigators anticipate that both circulating granulocyte pSTAT3+ activation and fecal calprotectin, as established biomarkers of colonic inflammation, will be reduced in subjects who receive Lactobacillus GG. Completion of the proposed studies will determine whether Lactobacillus GG reduces mucosal inflammation in pediatric UC, and will provide information to design a larger randomized trial.

The investigators' study design is novel in that it is the first probiotic study in children with UC and it will measure outcomes utilizing the biomarkers fecal calprotectin and pSTAT3+ circulating granulocytes.


Condition Intervention Phase
Ulcerative Colitis
Biological: Lactobacillus GG
Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open Label Pilot Study of Lactobacillus GG in Pediatric Ulcerative Colitis

Resource links provided by NLM:


Further study details as provided by Children's Hospital Medical Center, Cincinnati:

Primary Outcome Measures:
  • The primary endpoint will be a reduction in the fecal calprotectin level following the receipt of study agent. [ Time Frame: after dosing 28 - 35 days with LGG ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 20
Study Start Date: March 2011
Estimated Study Completion Date: October 2012
Estimated Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Intervention Details:
    Biological: Lactobacillus GG
    1 capsule taken twice daily for a minimum of 28 days to a maximum of 35 days.
    Other Name: Culturelle
  Eligibility

Ages Eligible for Study:   5 Years to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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 Criteria:

  • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00895336

Locations
United States, Ohio
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States, 45229
Sponsors and Collaborators
Children's Hospital Medical Center, Cincinnati
Investigators
Principal Investigator: Lee Denson, M.D. Children's Hospital Medical Center, Cincinnati
  More Information

No publications provided

Responsible Party: Lee Denson, M.D., Cincinnati Childrens
ClinicalTrials.gov Identifier: NCT00895336     History of Changes
Other Study ID Numbers: 2009-0443
Study First Received: April 27, 2009
Last Updated: February 8, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Children's Hospital Medical Center, Cincinnati:
Pediatric Ulcerative Colitis

Additional relevant MeSH terms:
Colitis
Ulcer
Colitis, Ulcerative
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
Intestinal Diseases
Pathologic Processes
Inflammatory Bowel Diseases

ClinicalTrials.gov processed this record on October 19, 2014