Lactobacillus GG in Pediatric Ulcerative Colitis (UC)

NCT00895336 | Withdrawn Phase 2 DMC

• 1 other identifier: 2009-0443
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Ulcerative Colitis

Keywords

Pediatric Ulcerative Colitis

Outcome Measures

Primary Outcomes (1)

• The primary endpoint will be a reduction in the fecal calprotectin level following the receipt of study agent.

  after dosing 28 - 35 days with LGG

Interventions

Lactobacillus GG BIOLOGICAL

1 capsule taken twice daily for a minimum of 28 days to a maximum of 35 days.

Also known as: Culturelle

Eligibility Criteria

• Age: 5 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Children's Hospital Medical Center, Cincinnati: lead

Study Sites (1)

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229, United States

Location

MeSH Terms

Conditions

Colitis, Ulcerative; Pediatric ulcerative colitis

Condition Hierarchy (Ancestors)

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

Study Officials

• Lee Denson, M.D.

  Children's Hospital Medical Center, Cincinnati

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: April 27, 2009
• First Posted: May 8, 2009
• Study Start: March 1, 2011
• Primary Completion: March 1, 2012
• Study Completion: October 1, 2012
• Last Updated: February 7, 2017

Record last verified: 2017-02

Locations

US (1)