Lcr35 for Children With Functional Constipation
Primary Purpose
Constipation
Status
Completed
Phase
Not Applicable
Locations
Poland
Study Type
Interventional
Intervention
Lactobacillus casei rhamnosus Lcr35
Placebo
Sponsored by

About this trial
This is an interventional treatment trial for Constipation
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
Sites / Locations
- Department of Pediatrics, Medical University of Warsaw
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Lactobacillus casei rhamnosus Lcr35
Placebo
Arm Description
Eligible children will receive Lactobacillus casei rhamnosus Lcr35 8×10^8 colony forming units (CFU), twice daily, orally for 4 weeks
Eligible children will receive placebo (maltodextrin), twice daily, orally for 4 weeks
Outcomes
Primary Outcome Measures
Number of Participants With Treatment Success (≥3 Spontaneous Defecations Per Week With no Fecal Soiling
Secondary Outcome Measures
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.
Defecation Frequency at Week 4
For single value median was calculated.
Fecal Soiling Episodes at Week 4
For single value median was calculated.
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.
Abdominal Pain at Week 4
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
Number of Participants With Adverse Effects
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.
Defecation Frequency at Week 1
Fecal Soiling Episodes at Week 1
Pain During Defecation at Week 1
Pain reported by child or symptoms of pain observed by parents. For single value median was calculated.
Abdominal Pain at Week 1
Abdominal pain reported by child or symptoms of pain observed by parents. For single value median was calculated.
Flatulence at Week 4
Flatulence reported by child or symptoms of pain observed by parents. For single value median was calculated.
Flatulence at Week 1
Flatulence reported by child or symptoms of pain observed by parents. For single value median was calculated.
Full Information
NCT ID
NCT01985867
First Posted
October 30, 2013
Last Updated
May 16, 2023
Sponsor
Medical University of Warsaw
1. Study Identification
Unique Protocol Identification Number
NCT01985867
Brief Title
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
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
November 2013 (undefined)
Primary Completion Date
November 2016 (Actual)
Study Completion Date
November 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medical University of Warsaw
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Constipation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
94 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Lactobacillus casei rhamnosus Lcr35
Arm Type
Experimental
Arm Description
Eligible children will receive Lactobacillus casei rhamnosus Lcr35 8×10^8 colony forming units (CFU), twice daily, orally for 4 weeks
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Eligible children will receive placebo (maltodextrin), twice daily, orally for 4 weeks
Intervention Type
Dietary Supplement
Intervention Name(s)
Lactobacillus casei rhamnosus Lcr35
Intervention Description
Eligible children will receive Lactobacillus casei rhamnosus Lcr35 (8×10^8 CFU, twice daily, orally for 4 weeks)
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Intervention Description
Eligible children will receive placebo (maltodextrin), twice daily, orally for 4 weeks
Primary Outcome Measure Information:
Title
Number of Participants With Treatment Success (≥3 Spontaneous Defecations Per Week With no Fecal Soiling
Time Frame
in the fourth week of the intervention
Secondary Outcome Measure Information:
Title
Stool Consistency at Week 4
Description
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.
Time Frame
during fourth week of intervention
Title
Defecation Frequency at Week 4
Description
For single value median was calculated.
Time Frame
during fourth week of intervention
Title
Fecal Soiling Episodes at Week 4
Description
For single value median was calculated.
Time Frame
during fourth week of intervention
Title
Number of Defecations That Were Painful at Week 4
Description
Pain reported by child or symptoms of pain observed by parents. For single value median was calculated.
Time Frame
during fourth weeks of intervention
Title
Abdominal Pain at Week 4
Description
Abdominal pain reported by child or symptoms of pain observed by parents. For single value median was calculated.
Time Frame
during fourth weeks of intervention
Title
Number of Participants With Use of Laxatives
Time Frame
during 4 weeks of intervention
Title
Number of Participants With Adverse Effects
Time Frame
during 4 weeks of intervention
Title
Stool Consistency at Week 1
Description
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.
Time Frame
during first week of intervention
Title
Defecation Frequency at Week 1
Time Frame
during first week of intervention
Title
Fecal Soiling Episodes at Week 1
Time Frame
during first week of intervention
Title
Pain During Defecation at Week 1
Description
Pain reported by child or symptoms of pain observed by parents. For single value median was calculated.
Time Frame
during first weeks of intervention
Title
Abdominal Pain at Week 1
Description
Abdominal pain reported by child or symptoms of pain observed by parents. For single value median was calculated.
Time Frame
during first weeks of intervention
Title
Flatulence at Week 4
Description
Flatulence reported by child or symptoms of pain observed by parents. For single value median was calculated.
Time Frame
during fourth weeks of intervention
Title
Flatulence at Week 1
Description
Flatulence reported by child or symptoms of pain observed by parents. For single value median was calculated.
Time Frame
during first weeks of intervention
10. Eligibility
Sex
All
Maximum Age & Unit of Time
5 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hania Szajewska, MD
Organizational Affiliation
Medical University of Warsaw
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Pediatrics, Medical University of Warsaw
City
Warsaw
ZIP/Postal Code
01-184
Country
Poland
12. IPD Sharing Statement
Citations:
PubMed Identifier
28284477
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.
Results Reference
derived
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Lcr35 for Children With Functional Constipation
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