Lcr35 for Children With Functional Constipation

Effectiveness of Lactobacillus Casei Rhamnosus Lcr35 in the Management of Children With Functional Constipation: a Randomized, Double-blind, Placebo- Controlled Trial.

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

Study Overview

• Status: Completed
• Conditions: Constipation
• Intervention / Treatment: Dietary supplement: Lactobacillus casei rhamnosus Lcr35; Dietary supplement: Placebo

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.

• Study Type: Interventional
• Enrollment (Actual): 94
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Poland
  • Warsaw, Poland, 01-184
    • Department of Pediatrics, Medical University of Warsaw

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 5 years (Child)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Lactobacillus casei rhamnosus Lcr35; Eligible children will receive Lactobacillus casei rhamnosus Lcr35 8×10^8 colony forming units (CFU), twice daily, orally for 4 weeks	Dietary supplement: Lactobacillus casei rhamnosus Lcr35; Eligible children will receive Lactobacillus casei rhamnosus Lcr35 (8×10^8 CFU, twice daily, orally for 4 weeks)
Placebo Comparator: Placebo; Eligible children will receive placebo (maltodextrin), twice daily, orally for 4 weeks	Dietary supplement: Placebo; Eligible children will receive placebo (maltodextrin), twice daily, orally for 4 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Number of Participants With Treatment Success (≥3 Spontaneous Defecations Per Week With no Fecal Soiling	in the fourth week of the intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Stool Consistency at Week 4	Stool consistency scores were determined using the 7-point Bristol Stool Form Scale (1 for hard lumps to 7 for watery stools). For single value median was calculated.	during fourth week of intervention
Defecation Frequency at Week 4	For single value median was calculated.	during fourth week of intervention
Fecal Soiling Episodes at Week 4	For single value median was calculated.	during fourth week of intervention
Number of Defecations That Were Painful at Week 4	Pain reported by child or symptoms of pain observed by parents. For single value median was calculated.	during fourth weeks of intervention
Abdominal Pain at Week 4	Abdominal pain reported by child or symptoms of pain observed by parents. For single value median was calculated.	during fourth weeks of intervention
Number of Participants With Use of Laxatives		during 4 weeks of intervention
Number of Participants With Adverse Effects		during 4 weeks of intervention
Stool Consistency at Week 1	Stool consistency scores were determined using the 7-point Bristol Stool Form Scale (1 for hard lumps to 7 for watery stools). For single value median was calculated.	during first week of intervention
Defecation Frequency at Week 1		during first week of intervention
Fecal Soiling Episodes at Week 1		during first week of intervention
Pain During Defecation at Week 1	Pain reported by child or symptoms of pain observed by parents. For single value median was calculated.	during first weeks of intervention
Abdominal Pain at Week 1	Abdominal pain reported by child or symptoms of pain observed by parents. For single value median was calculated.	during first weeks of intervention
Flatulence at Week 4	Flatulence reported by child or symptoms of pain observed by parents. For single value median was calculated.	during fourth weeks of intervention
Flatulence at Week 1	Flatulence reported by child or symptoms of pain observed by parents. For single value median was calculated.	during first weeks of intervention

Collaborators and Investigators

• Sponsor: Medical University of Warsaw
• Investigators: Principal Investigator: Hania Szajewska, MD, Medical University of Warsaw

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: November 1, 2013
• Primary Completion (Actual): November 1, 2016
• Study Completion (Actual): November 1, 2016

Study Registration Dates

• First Submitted: October 30, 2013
• First Submitted That Met QC Criteria: November 9, 2013
• First Posted (Estimate): November 15, 2013

Study Record Updates

• Last Update Posted (Actual): May 17, 2023
• Last Update Submitted That Met QC Criteria: May 16, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Signs and Symptoms, Digestive; Constipation
• Other Study ID Numbers: 1-2013