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Trial record 17 of 99 for:    Lactobacillus | maltodextrin

Lcr35 for Children With Functional Constipation

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

Tracking Information
First Submitted Date  ICMJE October 30, 2013
First Posted Date  ICMJE November 15, 2013
Last Update Posted Date November 8, 2016
Study Start Date  ICMJE November 2013
Actual Primary Completion Date November 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (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  ICMJE Same as current
Change History Complete list of historical versions of study NCT01985867 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (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  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Lcr35 for Children With Functional Constipation
Official Title  ICMJE 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  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Constipation
Intervention  ICMJE
  • 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  ICMJE
  • 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 9, 2013)
94
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE November 2016
Actual Primary Completion Date November 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE up to 5 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Poland
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01985867
Other Study ID Numbers  ICMJE 1-2013
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Katarzyna Wojtyniak, Medical University of Warsaw
Study Sponsor  ICMJE Medical University of Warsaw
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Hania Szajewska, MD Medical University of Warsaw
PRS Account Medical University of Warsaw
Verification Date November 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP