Lcr35 for Children With Functional Constipation

N/ACompletedNCT01985867

Medical University of Warsaw94 enrolled

Overview

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

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Constipation

Interventions

Lactobacillus casei rhamnosus Lcr35DIETARY_SUPPLEMENT

Eligible children will receive Lactobacillus casei rhamnosus Lcr35 (8×10\^8 CFU, twice daily, orally for 4 weeks)

PlaceboDIETARY_SUPPLEMENT

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

Eligibility

Sex: ALLMax age: 5 Years

Medical Language ↔ Plain English

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

Locations (1)

Department of Pediatrics, Medical University of Warsaw

Warsaw, Poland

Outcomes

Primary Outcomes

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 Outcomes

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.

Time frame: during fourth week of intervention

Defecation Frequency at Week 4

For single value median was calculated.

Time frame: during fourth week of intervention

Fecal Soiling Episodes at Week 4

For single value median was calculated.

Time frame: 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.

Time frame: 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.

Time frame: during fourth weeks of intervention

Number of Participants With Use of Laxatives

Time frame: during 4 weeks of intervention

Number of Participants With Adverse Effects

Time frame: during 4 weeks of intervention

Data from ClinicalTrials.gov

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