Lactobacillus Reuteri in Treatment of Functional Abdominal Pain and Chronic Constipation in Children

Summary

Beneficial therapeutic effect of probiotics has been reported in children with irritable bowel syndrome, but not consistently in other functional gastrointestinal disorders. Although there is evidence that probiotics increase stool frequency and decrease stool consistency in healthy individuals the evidence for efficacy in constipation is limited.

Children with functional abdominal pain (FAP) and constipation will be included in the study. Children with FAP will be randomized in one of two groups and will receive either L. reuteri in a daily dose of 108 CFU, or placebo during three months. Children with chronic constipation will receive either L. reuteri in a daily dose of 108 CFU and lactulose, or placebo and lactulose. Frequency and intensity of episodes of abdominal pain during and after intervention will be recorded in children with FAP. Frequency of defecation, stool consistency and need for lactulose will be recorded in children with chronic constipation.

Conditions

• Abdominal Pain
• Constipation - Functional

Interventions

DIETARY_SUPPLEMENT

Administration of L.reuteri in children with abdominal pain

Group of around 75 children which will receive L. reuteri at a dose 100.000.000 CFU per dose for 3 months. The active study product consists of a citrus flavored 450 mg chewable tablet containing freeze-dried L. reuteri DSM 17938. The study product is a convex tablet 10.3 mm in diameter, plain on both sides and with faint spots. It is composed of freeze-dried L. reuteri, isomalt, xylitol, sucrose distearate, hydrogenated palm oil, lemon-lime flavoring and anhydrous citric acid. The total viable count of L. reuteri is 1x100.000.000 live bacteria (CFU)/tablet.

DIETARY_SUPPLEMENT

Administration of placebo in children with abdominal pain

Group of around 75 children which will receive placebo for 3 months. The placebo consists of a citrus flavored 450 mg chewable convex tablet 10.3 mm in diameter, plain on both sides and with faint spots. It is composed of isomalt, xylitol, sucrose distearate, hydrogenated palm oil, lemon-lime flavoring and anhydrous citric acid.

DIETARY_SUPPLEMENT

Administration of L.reuteri in children with constipation

Group of around 75 children which will receive L. reuteri at a dose 100.000.000 CFU per dose plus lactulose in a dose 1-3 ml/kg, according to the stool frequency and consistency, for 3 months. The active study product consists of a citrus flavored 450 mg chewable tablet containing freeze-dried L. reuteri DSM 17938. The study product is a convex tablet 10.3 mm in diameter, plain on both sides and with faint spots. It is composed of freeze-dried L. reuteri, isomalt, xylitol, sucrose distearate, hydrogenated palm oil, lemon-lime flavoring and anhydrous citric acid. The total viable count of L. reuteri is 1x100.000.000 live bacteria (CFU)/tablet.

DIETARY_SUPPLEMENT

Administration of placebo in children with constipation

Group of around 75 children which will receive placebo plus lactulose in a dose 1-3 ml/kg, according to the stool frequency and consistency, for 3 months. The placebo study product consists of a citrus flavored 450 mg chewable convex tablet 10.3 mm in diameter, plain on both sides and with faint spots. It is composed of isomalt, xylitol, sucrose distearate, hydrogenated palm oil, lemon-lime flavoring and anhydrous citric acid.

Sponsors & Collaborators

• BioGaia AB

  collaborator INDUSTRY

• Sisters of Mercy University Hospital

  lead OTHER

Principal Investigators

• Sanja Kolaček, MD, PhD · Head, Department of Pediatrics, Clinical Professor

• Iva Hojsak, MD, PhD · Consultant in Pediatric Gastroenterology

• Oleg Jadrešin, MD, MSc · Consultant in Pediatric Gastroenterology

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

2 Years

Max Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2012-10-31

Primary Completion

2013-06-30

Completion

2013-10-31

Countries

• Croatia

Study Locations