Lcr35 for Children With Functional Constipation

Constipation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01985867
• Other study ID #: 1-2013
• Status: Completed
• Phase: N/A
• Start date: November 2013
• Est. completion date: November 2016

Study information

• Verified date: May 2023
• Source: Medical University of Warsaw
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 94
• Est. completion date: November 2016
• Est. primary completion date: November 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 5 Years

Eligibility

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

Related Conditions & MeSH terms

• Constipation

Intervention

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
Eligible children will receive placebo (maltodextrin), twice daily, orally for 4 weeks

Locations

Country	Name	City	State
Poland	Department of Pediatrics, Medical University of Warsaw	Warsaw

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Warsaw

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With Treatment Success (=3 Spontaneous Defecations Per Week With no Fecal Soiling		in the fourth week of the intervention
Secondary	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
Secondary	Defecation Frequency at Week 4	For single value median was calculated.	during fourth week of intervention
Secondary	Fecal Soiling Episodes at Week 4	For single value median was calculated.	during fourth week of intervention
Secondary	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
Secondary	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
Secondary	Number of Participants With Use of Laxatives		during 4 weeks of intervention
Secondary	Number of Participants With Adverse Effects		during 4 weeks of intervention
Secondary	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
Secondary	Defecation Frequency at Week 1		during first week of intervention
Secondary	Fecal Soiling Episodes at Week 1		during first week of intervention
Secondary	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
Secondary	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
Secondary	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
Secondary	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