Lactobacillus GG in Pediatric Ulcerative Colitis (UC)
| Status: | Withdrawn |
|---|---|
| Conditions: | Colitis, Colitis, Gastrointestinal |
| Therapuetic Areas: | Gastroenterology |
| Healthy: | No |
| Age Range: | 5 - 18 |
| Updated: | 2/8/2017 |
| Start Date: | March 2011 |
| End Date: | October 2012 |
An Open Label Pilot Study of Lactobacillus GG in Pediatric Ulcerative Colitis
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.
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.
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.
We found this trial at
1
site
3333 Burnet Avenue # Mlc3008
Cincinnati, Ohio 45229
Cincinnati, Ohio 45229
1-513-636-4200
Cincinnati Children's Hospital Medical Center Patients and families from across the region and around the...
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