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| Name | Class |
|---|---|
| Nicar Inc. | INDUSTRY |
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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 (Probaclacâ„¢) 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Probaclac | Experimental | 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 (Probaclacâ„¢) b.i.d. |
|
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Probaclac | Other | 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 (Probaclacâ„¢) |
| Measure | Description | Time Frame |
|---|---|---|
| Subjective assessment of improvement of symptoms | 4 weeks |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Christophe M Faure, MD | Ste-Justine Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hôpital Sainte Justine | Montreal | Quebec | H3T1C5 | Canada |
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| Label | URL |
|---|---|
| Related Info | View source |
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| ID | Term |
|---|---|
| D043183 | Irritable Bowel Syndrome |
| ID | Term |
|---|---|
| D003109 | Colonic Diseases, Functional |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
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| Placebo | Other | Placebo composition matodextrin, gelatin, ascorbic acid, soya |
|
| 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 |
| D004066 | Digestive System Diseases |