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

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2012 by Sisters of Mercy University Hospital
Sponsor:
Collaborator:
BioGaia AB
Information provided by (Responsible Party):
Sanja Kolacek, MD, PhD, Sisters of Mercy University Hospital
ClinicalTrials.gov Identifier:
NCT01587846
First received: April 23, 2012
Last updated: October 2, 2012
Last verified: October 2012
  Purpose

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.


Condition Intervention Phase
Abdominal Pain
Constipation - Functional
Dietary Supplement: Administration of L.reuteri in children with abdominal pain
Dietary Supplement: Administration of placebo in children with abdominal pain
Dietary Supplement: Administration of L.reuteri in children with constipation
Dietary Supplement: Administration of placebo in children with constipation
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Lactobacillus Reuteri in Treatment of Functional Abdominal Pain and Chronic Constipation in Children - Randomized, Double Blind, Placebo Controlled Study

Resource links provided by NLM:


Further study details as provided by Sisters of Mercy University Hospital:

Primary Outcome Measures:
  • Intensity of abdominal pain [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Pain score on visual-analogue scale during treatment

  • Severity of chronic constipation [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Stool consistency score on Bristol stool scale during treatment


Secondary Outcome Measures:
  • Intensity of abdominal pain after treatment [ Time Frame: 1 month ] [ Designated as safety issue: No ]
    Pain score on visual-analogue scale in a period of 1 month after stopping treatment

  • Severity of chronic constipation after treatment [ Time Frame: 1 month ] [ Designated as safety issue: No ]
    Stool consistency score on Bristol stool scale in a period of 1 month after stopping treatment


Estimated Enrollment: 300
Study Start Date: October 2012
Estimated Study Completion Date: October 2013
Estimated Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Probiotic/abdominal pain
Children with functional abdominal pain that will receive probiotic.
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.
Experimental: Placebo/abdominal pain
Children with functional abdominal pain that will receive placebo.
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.
Experimental: Probiotic/constipation
Children with chronic constipation tha will receive probiotic plus lactulose
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.
Experimental: Placebo/chronic constipation
Children with chronic constipation that will receive placebo plus lactulose
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.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   2 Years to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Children with functional abdominal pain (age 4-18 years)
  • Children with chronic constipation (age 2-18 years)

Exclusion Criteria:

  • Immunodeficiency
  • Receiving probiotic and/or prebiotic products 7 days prior to enrolment
  • Neoplasms
  • Chronic disorders
  • Presence of "red flags":

    • Weight loss of more than 10%
    • Growth retardation or growth failure
    • Extraintestinal symptoms (fever, rash, joint pain, aphthae, affection of the urinary system)
    • Frequent vomiting
    • Abnormalities in laboratory findings (anemia, elevated ESR)
    • Abnormalities in clinical findings (organomegaly, perianal disease)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01587846

Contacts
Contact: Oleg Jadrešin, MD, MSc 00385914600130 oleg.jadresin@gmail.com

Locations
Croatia
University Hospital Centre "Sisters of Mercy" Recruiting
Zagreb, Croatia, 10000
Contact: Sanja Kolaček    0038514600291    sanja.kolacek@gmail.com   
Sponsors and Collaborators
Sisters of Mercy University Hospital
BioGaia AB
Investigators
Principal Investigator: Sanja Kolaček, MD, PhD Head, Department of Pediatrics, Clinical Professor
Study Director: Iva Hojsak, MD, PhD Consultant in Pediatric Gastroenterology
Study Chair: Oleg Jadrešin, MD, MSc Consultant in Pediatric Gastroenterology
  More Information

Publications:

Responsible Party: Sanja Kolacek, MD, PhD, Head of the Department of Pediatrics, Clinical Professor, Principal Investigator, Sisters of Mercy University Hospital
ClinicalTrials.gov Identifier: NCT01587846     History of Changes
Other Study ID Numbers: LR-2012-KL
Study First Received: April 23, 2012
Last Updated: October 2, 2012
Health Authority: Croatia: Ministry of Health and Social Care

Keywords provided by Sisters of Mercy University Hospital:
abdominal pain, constipation, Lactobacillus reuteri

Additional relevant MeSH terms:
Abdominal Pain
Constipation
Pain
Signs and Symptoms
Signs and Symptoms, Digestive

ClinicalTrials.gov processed this record on August 26, 2014