Constipation | Lcr35 for Children With Functional Constipation
Constipation research study
What is the primary objective of this study?
The aim of this study is to assess the effectiveness of Lactobacillus casei rhamnosus Lcr35 administration for the treatment of functional constipation in children.
Who is eligible to participate?
Inclusion Criteria: - Children below 5 years of age - Functional constipation according to Rome III criteria i.e. 1 month of at least 2 of the following: - Two or fewer defecations per week - At least 1 episode per week of incontinence after the acquisition of toileting skills - History of excessive stool retention - History of painful or hard bowel movements - Presence of a large fecal mass in the rectum - History of large- diameter stools that may obstruct the toilet Exclusion Criteria: - Irritable bowel syndrome - Mental retardation - Endocrine disease (e.g. hypothyroidism) - Organic cause of constipation (e.g. Hirschsprung disease) - Spinal anomalies - Anatomic defects of the anorectum - History of previous gastrointestinal surgery - Functional nonretentive fecal incontinence - Use of drugs that influence gastrointestinal motility
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
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:Lactobacillus casei rhamnosus Lcr35Eligible children will receive Lactobacillus casei rhamnosus Lcr35 (8×10^8 CFU, twice daily, orally for 4 weeks)
Dietary Supplement:PlaceboEligible children will receive placebo (maltodextrin), twice daily, orally for 4 weeks
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.
Lactobacillus casei rhamnosus Lcr35Eligible children will receive Lactobacillus casei rhamnosus Lcr35 8×10^8 colony forming units (CFU), twice daily, orally for 4 weeks
PlaceboEligible children will receive placebo (maltodextrin), twice daily, orally for 4 weeks
Start Date: November 2013
Completed Date: November 2016
Phase: Phase 4
Primary Outcome: treatment success (≥3 spontaneous defecations per week with no fecal soiling)
Secondary Outcome: stool consistency (with the use of the Bristol Stool Scale Form)
Study sponsors, principal investigator, and references
Principal Investigator: Hania Szajewska, MD
Lead Sponsor: Medical University of Warsaw