Lactobacillus Reuteri in Treatment of Functional Abdominal Pain and Chronic Constipation in Children
Unknown statusPhase 3NCT01587846
View the official record on ClinicalTrials.gov Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.
This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
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.
Study details
- Official title
- Lactobacillus Reuteri in Treatment of Functional Abdominal Pain and Chronic Constipation in Children - Randomized, Double Blind, Placebo Controlled Study
- Conditions
- Abdominal Pain
- Constipation - Functional
- Interventions
- 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
- Sponsor
- Sisters of Mercy University Hospital
- Collaborators
- BioGaia AB
- Start date
- 2012-10
- Primary completion
- 2013-06
- Sex
- All
- Age range
- from 2 Years to 18 Years
- Results posted
- No results posted in this snapshot
- Countries
- Croatia
- Total sites listed
- 1
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
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)
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT01587846