Department of Pediatrics, Medical University of Warsaw
Warsaw, 01-184, Poland
NCT Number: NCT01985867
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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Notify MeUp to 5 year
All sexes
Interventional
Not applicable
Warsaw, 01-184, Poland
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Eligible children will receive Lactobacillus casei rhamnosus Lcr35 (8×10^8 CFU, twice daily, orally for 4 weeks)
Eligible children will receive placebo (maltodextrin), twice daily, orally for 4 weeks
Time frame: in the fourth week of the intervention
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.
Time frame: during fourth week of intervention
For single value median was calculated.
Time frame: during fourth week of intervention
For single value median was calculated.
Time frame: during fourth weeks of intervention
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 reported by child or symptoms of pain observed by parents. For single value median was calculated.
Time frame: during 4 weeks of intervention
Time frame: during 4 weeks of intervention
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.
Time frame: during first week of intervention
Time frame: during first week of intervention
Time frame: during first weeks of intervention
Pain reported by child or symptoms of pain observed by parents. For single value median was calculated.
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.
Time frame: during fourth weeks of intervention
Flatulence reported by child or symptoms of pain observed by parents. For single value median was calculated.
Time frame: during first weeks of intervention
Flatulence reported by child or symptoms of pain observed by parents. For single value median was calculated.
Medical University of Warsaw
Other
Effectiveness of Lactobacillus Casei Rhamnosus Lcr35 in the Management of Children With Functional Constipation: a Randomized, Double-blind, Placebo- Controlled Trial.
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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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