Lcr35 for Children With Functional Constipation

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Constipation

Intervention / Treatment
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* Dietary Supplement: Lactobacillus casei rhamnosus Lcr35
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Maximum Age: 5 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lactobacillus casei rhamnosus Lcr35<br>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<br>* Eligible children will receive Lactobacillus casei rhamnosus Lcr35 (8×10^8 CFU, twice daily, orally for 4 weeks)<br>|
| Placebo Comparator: Placebo<br>Eligible children will receive placebo (maltodextrin), twice daily, orally for 4 weeks | Dietary Supplement: Placebo<br>* Eligible children will receive placebo (maltodextrin), twice daily, orally for 4 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 |