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Completed

NCT Number: NCT01985867

Lcr35 for Children With Functional Constipation

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

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Key information

Age range

Up to 5 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Pediatrics, Medical University of Warsaw

Warsaw, 01-184, Poland

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Lactobacillus casei rhamnosus Lcr35

Dietary Supplement

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

Placebo

Dietary Supplement

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

Primary outcomes

  1. 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

  1. Stool Consistency at Week 4

    Time frame: during fourth week of intervention

    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.

  2. Defecation Frequency at Week 4

    Time frame: during fourth week of intervention

    For single value median was calculated.

  3. Fecal Soiling Episodes at Week 4

    Time frame: during fourth week of intervention

    For single value median was calculated.

  4. Number of Defecations That Were Painful at Week 4

    Time frame: during fourth weeks of intervention

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

  5. Abdominal Pain at Week 4

    Time frame: during fourth weeks of intervention

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

  6. Number of Participants With Use of Laxatives

    Time frame: during 4 weeks of intervention

  7. Number of Participants With Adverse Effects

    Time frame: during 4 weeks of intervention

  8. Stool Consistency at Week 1

    Time frame: during first week of intervention

    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.

  9. Defecation Frequency at Week 1

    Time frame: during first week of intervention

  10. Fecal Soiling Episodes at Week 1

    Time frame: during first week of intervention

  11. Pain During Defecation at Week 1

    Time frame: during first weeks of intervention

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

  12. Abdominal Pain at Week 1

    Time frame: during first weeks of intervention

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

  13. Flatulence at Week 4

    Time frame: during fourth weeks of intervention

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

  14. Flatulence at Week 1

    Time frame: during first weeks of intervention

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

Sponsors and collaborators

Lead sponsor

Medical University of Warsaw

Other

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2016
Study completion
2016
First posted
Nov 15, 2013
Registry last updated
May 17, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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