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

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

Status

Terminated

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00793494

Acronym

POPSII

Enrollment

Registered

2008-11-19

Start date

2009-01-31

Completion date

2015-05-31

Last updated

2016-04-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Irritable Bowel Syndrome

Keywords

Irritable bowel syndrome, Children, Pediatrics, Probiotics

Brief summary

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.

Interventions

OTHERProbaclac

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™)

OTHERPlacebo

Placebo composition matodextrin, gelatin, ascorbic acid, soya

Study design

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

8 Years to 18 Years

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

Design outcomes

Primary

Measure	Time frame
Subjective assessment of improvement of symptoms	4 weeks

Secondary

Measure	Time frame
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
Change in severity of symptoms (likert scale)	4 weeks
Quality of Life	4 weeks
Adverse Events	2 months
School and social absenteism	4 weeks

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026