Lactobacillus Reuteri in Treatment of Functional Abdominal Pain and Chronic Constipation in Children - Full Text View

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:

MedlinePlus related topics: Abdominal Pain Bowel Movement Constipation

Drug Information available for: Lactobacillus

U.S. FDA Resources

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

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:

Savino F, Cordisco L, Tarasco V, Palumeri E, Calabrese R, Oggero R, Roos S, Matteuzzi D. Lactobacillus reuteri DSM 17938 in infantile colic: a randomized, double-blind, placebo-controlled trial. Pediatrics. 2010 Sep;126(3):e526-33. Epub 2010 Aug 16.

Coccorullo P, Strisciuglio C, Martinelli M, Miele E, Greco L, Staiano A. Lactobacillus reuteri (DSM 17938) in infants with functional chronic constipation: a double-blind, randomized, placebo-controlled study. J Pediatr. 2010 Oct;157(4):598-602. Epub 2010 Jun 12.

Szajewska H. Probiotics and functional gastrointestinal disorders. J Pediatr Gastroenterol Nutr. 2011 Dec;53 Suppl 2:S30-2.

Tabbers MM, Chmielewska A, Roseboom MG, Crastes N, Perrin C, Reitsma JB, Norbruis O, Szajewska H, Benninga MA. Fermented milk containing Bifidobacterium lactis DN-173 010 in childhood constipation: a randomized, double-blind, controlled trial. Pediatrics. 2011 Jun;127(6):e1392-9. Epub 2011 May 23.

Horvath A, Dziechciarz P, Szajewska H. Meta-analysis: Lactobacillus rhamnosus GG for abdominal pain-related functional gastrointestinal disorders in childhood. Aliment Pharmacol Ther. 2011 Jun;33(12):1302-10. doi: 10.1111/j.1365-2036.2011.04665.x. Epub 2011 Apr 20.

Chmielewska A, Szajewska H. Systematic review of randomised controlled trials: probiotics for functional constipation. World J Gastroenterol. 2010 Jan 7;16(1):69-75. Review.

Gawrońska A, Dziechciarz P, Horvath A, Szajewska H. A randomized double-blind placebo-controlled trial of Lactobacillus GG for abdominal pain disorders in children. Aliment Pharmacol Ther. 2007 Jan 15;25(2):177-84.

Szajewska H, Setty M, Mrukowicz J, Guandalini S. Probiotics in gastrointestinal diseases in children: hard and not-so-hard evidence of efficacy. J Pediatr Gastroenterol Nutr. 2006 May;42(5):454-75. Review.

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 June 17, 2013