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

Abdominal Pain research study

What is the primary objective of this study?

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.

Who is eligible to participate?

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)

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Abdominal Pain

Constipation - Functional

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Dietary Supplement:Administration of L.reuteri in children with abdominal painGroup 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 painGroup 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 constipationGroup 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 constipationGroup 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.

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

Probiotic/abdominal painChildren with functional abdominal pain that will receive probiotic.

Placebo/abdominal painChildren with functional abdominal pain that will receive placebo.

Probiotic/constipationChildren with chronic constipation tha will receive probiotic plus lactulose

Placebo/chronic constipationChildren with chronic constipation that will receive placebo plus lactulose

Study Status

Unknown status

Start Date: October 2012

Completed Date: October 2013

Phase: Phase 3

Type: Interventional

Design:

Primary Outcome: Intensity of abdominal pain

Secondary Outcome: Intensity of abdominal pain after treatment

Study sponsors, principal investigator, and references

Principal Investigator: Sanja Kolańćek, MD, PhD

Lead Sponsor: Sisters of Mercy University Hospital

Collaborator: BioGaia AB

More information:https://clinicaltrials.gov/show/NCT01587846

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. doi: 10.1542/peds.2010-0433. Epub 2010 Aug 16.

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