Probiotic preparation VSL#3 induces remission in children with mild to moderate acute ulcerative colitis: a pilot study.
BACKGROUND
Ulcerative colitis (UC) is a form of inflammatory bowel disease (IBD) that has periods of exacerbated symptoms and periods that are symptom-free. The treatment of active UC with probiotic bacteria could possibly induce remission. We evaluated the clinical efficacy and safety profile of probiotic preparation VSL#3 in the treatment of mild to moderate acute UC in the pediatric population.


METHODS
Eighteen eligible patients between the ages of 3-17 with mild to moderate acute UC received open-label VSL#3 daily in 2 divided doses for 8 weeks. The disease activity pre- and post-VSL#3 therapy was assessed by the simple clinical colitis activity index (SCCAI); Mayo ulcerative colitis endoscopic score; inflammatory markers: erythrocyte sedimentation rate (ESR) and C-reactive protein (CRP); serum cytokine profiling; and rectal tissue microbial profiling done at baseline and at week 8.


RESULTS
Thirteen patients completed 8 weeks of VSL#3 treatment and 5 patients were withdrawn due to lack of improvement. Remission (defined as SCCAI <or=3) was achieved in 56% of children (n = 10); response (decrease in SCCAI >or=2, but final score <or=5) in 6% (n = 1); and no change or worsening in 39% (n = 7). Post-VSL#3 treatments demonstrated a bacterial taxonomy change in rectal biopsy. The VSL#3 was well tolerated in clinical trials and no biochemical and clinical adverse effects attributed to VSL#3 were identified.


CONCLUSIONS
Treatment of pediatric patients diagnosed with mild to moderate UC with VSL#3 resulted in a remission rate of 56% and a combined remission/response rate of 61%.
Huynh
Hien Q
HQ
Division of Pediatric Gastroenterology and Nutrition, Department of Pediatrics, University of Alberta, Stollery Children's Hospital, Edmonton, Alberta, Canada. Hien.Huynh@ualberta.ca
deBruyn
Jennifer
J
Guan
Leluo
L
Diaz
Hugo
H
Li
Meiju
M
Girgis
Safwat
S
Turner
Justine
J
Fedorak
Richard
R
Madsen
Karen
K
D000293:Adolescent; D002648:Child; D002675:Child, Preschool; D003093:Colitis, Ulcerative / Q000473:pathology / Q000628:therapy*; D005260:Female; D006801:Humans; D008297:Male; D010865:Pilot Projects; D019936:Probiotics / Q000627:therapeutic use*; D012074:Remission Induction; D012449:Safety; D016896:Treatment Outcome