Lcr35 for Children With Functional Constipation

Not Applicable

Completed

• Conditions: Constipation
• Interventions: Dietary Supplement: Placebo; Dietary Supplement: Lactobacillus casei rhamnosus Lcr35

• Registration Number: NCT01985867
• Lead Sponsor: Medical University of Warsaw

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.

Study Timeline

• Study First Submitted: 2013-10-30
• Study Start: 2013-11
• Study First Submitted QC: 2013-11-09
• Study First Posted: 2013-11-15
• Primary Completion: 2016-11
• Study Completion: 2016-11
• Results First Submitted: 2017-07-02
• Status Verified: 2023-05
• Results First Submitted QC: 2023-05-16
• Last Update Submitted: 2023-05-16
• Results First Posted: 2023-05-17
• Last Update Posted: 2023-05-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 94

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Eligible children will receive placebo (maltodextrin), twice daily, orally for 4 weeks
Lactobacillus casei rhamnosus Lcr35	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

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Fecal Soiling Episodes at Week 1	during first week of intervention
Defecation Frequency at Week 1	during first week of intervention
Stool Consistency at Week 4	during fourth week of intervention	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.
Defecation Frequency at Week 4	during fourth week of intervention	For single value median was calculated.
Fecal Soiling Episodes at Week 4	during fourth week of intervention	For single value median was calculated.
Number of Defecations That Were Painful at Week 4	during fourth weeks of intervention	Pain reported by child or symptoms of pain observed by parents. For single value median was calculated.
Abdominal Pain at Week 4	during fourth weeks of intervention	Abdominal pain reported by child or symptoms of pain observed by parents. For single value median was calculated.
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	during first week of intervention	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.
Pain During Defecation at Week 1	during first weeks of intervention	Pain reported by child or symptoms of pain observed by parents. For single value median was calculated.
Abdominal Pain at Week 1	during first weeks of intervention	Abdominal pain reported by child or symptoms of pain observed by parents. For single value median was calculated.
Flatulence at Week 4	during fourth weeks of intervention	Flatulence reported by child or symptoms of pain observed by parents. For single value median was calculated.
Flatulence at Week 1	during first weeks of intervention	Flatulence reported by child or symptoms of pain observed by parents. For single value median was calculated.

Trial Locations

Locations (1)

Department of Pediatrics, Medical University of Warsaw; 🇵🇱 Warsaw, Poland