Lcr35 for Children With Functional Constipation

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

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.

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 Lactobacillus casei rhamnosus Lcr35 (8×10^8 CFU, twice daily, orally for 4 weeks)

Number of Participants With Treatment Success (≥3 Spontaneous Defecations Per Week With no Fecal Soiling

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 reported by child or symptoms of pain observed by parents. For single value median was calculated.

Abdominal pain reported by child or symptoms of pain observed by parents. For single value median was calculated.

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 reported by child or symptoms of pain observed by parents. For single value median was calculated.

Abdominal pain reported by child or symptoms of pain observed by parents. For single value median was calculated.

Flatulence reported by child or symptoms of pain observed by parents. For single value median was calculated.

Flatulence reported by child or symptoms of pain observed by parents. For single value median was calculated.

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

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.