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

St. Justine's Hospital

Status and phase: Terminated; Phase 2

Conditions: Irritable Bowel Syndrome

Treatments: Other: Probaclac; Other: Placebo

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00793494

Probaclac-HSJ

Details and patient eligibility

About

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.

Enrollment: 44 patients

Sex: All

Ages: 8 to 18 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Quadruple Blind

---

44 participants in 2 patient groups, including a placebo group

Probaclac

Experimental group

Description:

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.

Treatment:

Other: Probaclac

Placebo

Placebo Comparator group

Treatment:

Other: Placebo