The aim of this study is to determine the efficacy of the administration of Bifidobacterium bifidum R0071, Bifidobacterium longum R0175, Lactobacillus helveticus R0052, Lactobacillus Delb. SSP bulgaricus R9001, Lactobacillus rhamnosus R0011, Lactococcus Lactis SSP. lactis R1058 et Streptococcus thermophilus (Probaclac™) given twice a day for 4 weeks on digestive symptoms evaluated subjectively in children aged 8 to 18 years with irritable bowel syndrome versus placebo. This study is a double-blind randomized controlled study. 84 children will included. After inclusion, a 15-day period of observation precedes the randomization at Day 0. Patients receive Probaclac or placebo for 4 weeks. At the end of the treatment period, patients are followed for a 2-week period of follow-up. 4 visits and 4 phone calls are planned during the study.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
44
Bifidobacterium bifidum R0071, Bifidobacterium longum R0175, Lactobacillus helveticus R0052, Lactobacillus Delb. SSP bulgaricus R9001, Lactobacillus rhamnosus R0011, Lactococcus Lactis SSP. lactis R1058 et Streptococcus thermophilus (Probaclac™)
Placebo composition matodextrin, gelatin, ascorbic acid, soya
Hôpital Sainte Justine
Montreal, Quebec, Canada
Subjective assessment of improvement of symptoms
Time frame: 4 weeks
Change in severity of symptoms (likert scale)
Time frame: 4 weeks
Presence and intensity of pain episodes
Time frame: 4 weeks
Presence or absence of urgency, incomplete evacuation, gas
Time frame: 4 weeks
Number and consistance of the stools
Time frame: 4 weeks
School and social absenteism
Time frame: 4 weeks
Quality of Life
Time frame: 4 weeks
Adverse Events
Time frame: 2 months
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