Lcr35 for Children With Functional Constipation

• ClinicalTrials.gov Identifier: NCT01985867
• Recruitment Status: Completed
• First Posted: November 15, 2013
• Last Update Posted: November 8, 2016
• Sponsor: Medical University of Warsaw
• Information provided by (Responsible Party): Katarzyna Wojtyniak, Medical University of Warsaw

Tracking Information

• First Submitted Date: October 30, 2013
• First Posted Date: November 15, 2013
• Last Update Posted Date: November 8, 2016
• Study Start Date: November 2013
• Actual Primary Completion Date: November 2016 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: November 9, 2013): treatment success (≥3 spontaneous defecations per week with no fecal soiling) [ Time Frame: in the fourth week of the intervention ]
• Original Primary Outcome Measures: Same as current
• Change History: Complete list of historical versions of study NCT01985867 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures (submitted: November 9, 2013)

• stool consistency (with the use of the Bristol Stool Scale Form) [ Time Frame: during 4 weeks of intervention ]
• stool frequency [ Time Frame: during 4 weeks of intervention ]
• fecal soiling episodes [ Time Frame: during 4 weeks of intervention ]
• pain during defecation [ Time Frame: during 4 weeks of intervention ]
• abdominal pain and/or flatulence [ Time Frame: during 4 weeks of intervention ]
• use of laxatives [ Time Frame: during 4 weeks of intervention ]
• adverse effects [ Time Frame: during 4 weeks of intervention ]
• fecal microbiological sampling (global evolution of Lactobacillus and Bifidobacterium) [ Time Frame: during 4 weeks of intervention ]
  fecal sampling will be performed before and at the 4th week of intervention

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Lcr35 for Children With Functional Constipation
• Official Title: Effectiveness of Lactobacillus Casei Rhamnosus Lcr35 in the Management of Children With Functional Constipation: a Randomized, Double-blind, Placebo- Controlled Trial.
• 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.
• Study Type: Interventional
• Study Phase: Phase 4
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment
• Condition: Constipation

Intervention

• Dietary Supplement: Lactobacillus casei rhamnosus Lcr35
  Eligible children will receive Lactobacillus casei rhamnosus Lcr35 (8×10^8 CFU, twice daily, orally for 4 weeks)
• Dietary Supplement: Placebo
  Eligible children will receive placebo (maltodextrin), twice daily, orally for 4 weeks

Study Arms

• Experimental: 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
  Intervention: Dietary Supplement: Lactobacillus casei rhamnosus Lcr35
• Placebo Comparator: Placebo
  Eligible children will receive placebo (maltodextrin), twice daily, orally for 4 weeks
  Intervention: Dietary Supplement: Placebo

• Publications *: 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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: November 9, 2013): 94
• Original Estimated Enrollment: Same as current
• Actual Study Completion Date: November 2016
• Actual Primary Completion Date: November 2016 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: up to 5 Years (Child)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Poland

Administrative Information

• NCT Number: NCT01985867
• Other Study ID Numbers: 1-2013
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Katarzyna Wojtyniak, Medical University of Warsaw
• Study Sponsor: Medical University of Warsaw
• Collaborators: Not Provided

Investigators

• Principal Investigator: Hania Szajewska, MD; Medical University of Warsaw

• PRS Account: Medical University of Warsaw
• Verification Date: November 2016