Clinical trial NCT01985867: Lcr35 for Children With Functional Constipation
Official title: Effectiveness of Lactobacillus Casei Rhamnosus Lcr35 in the Management of Children With Functional Constipation: a Randomized, Double-blind, Placebo- Controlled Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Constipation
Lead sponsor: Medical University of Warsaw
Sponsor class: OTHER
First posted: 2013-11-15
Enrollment: 94
Sex: ALL
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study is to assess the effectiveness of Lactobacillus casei rhamnosus Lcr35 administration for the treatment of functional constipation in children.

Detailed description: Functional constipation is a common problem which affects over 3% of children. The standard treatment does not provide sustained relief of symptoms. As a consequence, there is interest in other therapeutic options. Previously, one small (n=40) randomized controlled trial (RCT) involving 27 children showed that Lactobacillus rhamnosus casei Lcr35 compared with placebo increased treatment success defined as ≥ 3 spontaneous defecations per week with no episodes of faecal soiling, increased the defecation frequency, reduced the frequency of abdominal pain, reduced the use of glycerin enemas during the four weeks of therapy, and decreased the percentage of hard stools. However, there was no difference between groups in the use of lactulose or the number of episodes of faecal soiling. Available evidence is insufficient to draw meaningful conclusion. Further studies are needed.

Eligibility criteria: 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

Primary outcomes:
measure: Number of Participants With Treatment Success (≥3 Spontaneous Defecations Per Week With no Fecal Soiling
timeFrame: in the fourth week of the intervention
Secondary outcomes:
measure: Stool Consistency at Week 4
timeFrame: during fourth week of intervention
measure: Defecation Frequency at Week 4
timeFrame: during fourth week of intervention
measure: Fecal Soiling Episodes at Week 4
timeFrame: during fourth week of intervention
measure: Number of Defecations That Were Painful at Week 4
timeFrame: during fourth weeks of intervention
measure: Abdominal Pain at Week 4
timeFrame: during fourth weeks of intervention
measure: Number of Participants With Use of Laxatives
timeFrame: during 4 weeks of intervention
measure: Number of Participants With Adverse Effects
timeFrame: during 4 weeks of intervention
measure: Stool Consistency at Week 1
timeFrame: during first week of intervention
measure: Defecation Frequency at Week 1
timeFrame: during first week of intervention
measure: Fecal Soiling Episodes at Week 1
timeFrame: during first week of intervention
measure: Pain During Defecation at Week 1
timeFrame: during first weeks of intervention
measure: Abdominal Pain at Week 1
timeFrame: during first weeks of intervention
measure: Flatulence at Week 4
timeFrame: during fourth weeks of intervention
measure: Flatulence at Week 1
timeFrame: during first weeks of intervention
Other outcomes:
Locations:
city: Warsaw
country: Poland
facility: Department of Pediatrics, Medical University of Warsaw
Study officials:
affiliation: Medical University of Warsaw
name: Hania Szajewska, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Wojtyniak K, Horvath A, Dziechciarz P, Szajewska H. Lactobacillus casei rhamnosus Lcr35 in the Management of Functional Constipation in Children: A Randomized Trial. J Pediatr. 2017 May;184:101-105.e1. doi: 10.1016/j.jpeds.2017.01.068. Epub 2017 Mar 8.