Lcr35 for Children With Functional Constipation

NCT ID: NCT01985867

Last Updated: 2023-05-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 94 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-11-30
• Study Completion Date: 2016-11-30

Brief Summary

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

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.

Conditions

Constipation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Lactobacillus casei rhamnosus Lcr35

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

Group Type: EXPERIMENTAL

Lactobacillus casei rhamnosus Lcr35

Intervention Type: DIETARY_SUPPLEMENT

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

Placebo

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

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DIETARY_SUPPLEMENT

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

Interventions

Lactobacillus casei rhamnosus Lcr35

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

Intervention Type: DIETARY_SUPPLEMENT

Placebo

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

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

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

• Maximum Eligible Age: 5 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medical University of Warsaw

OTHER

Sponsor Role: lead

Responsible Party

Katarzyna Wojtyniak

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Hania Szajewska, MD

Role: PRINCIPAL_INVESTIGATOR

Medical University of Warsaw

Locations

Department of Pediatrics, Medical University of Warsaw

Warsaw, , Poland

Countries

Poland

References

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.

Reference Type: DERIVED

PMID: 28284477 (View on PubMed)

Other Identifiers

1-2013

Identifier Type: -

Identifier Source: org_study_id