Efficacy of Probaclac in Irritable Bowel Syndrome in Children Aged 8 to 18 Years

Study Overview
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Brief Summary
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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.

Official Title
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Randomized Controlled Trial of Probaclac Versus Placebo in Children Aged 8 to 18 Years With Irritable Bowel Syndrome

Conditions
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Irritable Bowel Syndrome

Intervention / Treatment
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* Other: Probaclac
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Children 8 to 18 years Irritable bowel syndrome according to Rome III criteria Exclusion Criteria: Not able to collaborate Known Digestive malformation History of digestive surgery (except hernia repair and appendectomy) History of known digestive disease (Crohn's, ulcerative colitis, esophagitis, peptic ulcer, celiac disease) Symptoms suggestive of organic disease (such as rectal bleeding, weight loss History of chronic extra-digestive disease Acute gastroenteritis in th e4 weeks prior to inclusion Central catheter, artificial cardiac valve, endocardiac prothesis Current Antidepressant treatment Patients taking a treatment for irritable bowel syndrome unable to cease their current treatment Patient taking regularly probiotics and natural products

Ages Eligible for Study
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Minimum Age: 8 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Probaclac<br>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™) b.i.d. | Other: Probaclac<br>* 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™)<br>|
| Placebo Comparator: Placebo<br> | Other: Placebo<br>* Placebo composition matodextrin, gelatin, ascorbic acid, soya<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Subjective assessment of improvement of symptoms |  | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in severity of symptoms (likert scale) |  | 4 weeks | 
| Presence and intensity of pain episodes |  | 4 weeks | 
| Presence or absence of urgency, incomplete evacuation, gas |  | 4 weeks | 
| Number and consistance of the stools |  | 4 weeks | 
| School and social absenteism |  | 4 weeks | 
| Quality of Life |  | 4 weeks | 
| Adverse Events |  | 2 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Irritable bowel syndrome, Children, Pediatrics, Probiotics