NCT01985867

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
94

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2013

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 30, 2013

Completed
2 days until next milestone

Study Start

First participant enrolled

November 1, 2013

Completed
14 days until next milestone

First Posted

Study publicly available on registry

November 15, 2013

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2016

Completed
6.5 years until next milestone

Results Posted

Study results publicly available

May 17, 2023

Completed
Last Updated

May 17, 2023

Status Verified

May 1, 2023

Enrollment Period

3 years

First QC Date

October 30, 2013

Results QC Date

July 2, 2017

Last Update Submit

May 16, 2023

Conditions

Constipation

Outcome Measures

Primary Outcomes (1)

  • Number of Participants With Treatment Success (≥3 Spontaneous Defecations Per Week With no Fecal Soiling

    in the fourth week of the intervention

Secondary Outcomes (14)

  • Stool Consistency at Week 4

    during fourth week of intervention

  • Defecation Frequency at Week 4

    during fourth week of intervention

  • Fecal Soiling Episodes at Week 4

    during fourth week of intervention

  • Number of Defecations That Were Painful at Week 4

    during fourth weeks of intervention

  • Abdominal Pain at Week 4

    during fourth weeks of intervention

  • +9 more secondary outcomes

Study Arms (2)

Lactobacillus casei rhamnosus Lcr35

EXPERIMENTAL

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

Dietary Supplement: Lactobacillus casei rhamnosus Lcr35

Placebo

PLACEBO COMPARATOR

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

Dietary Supplement: Placebo

Interventions

Lactobacillus casei rhamnosus Lcr35DIETARY_SUPPLEMENT

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

Lactobacillus casei rhamnosus Lcr35
PlaceboDIETARY_SUPPLEMENT

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

Placebo

Eligibility Criteria

AgeUp to 5 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Pediatrics, Medical University of Warsaw

Warsaw, 01-184, Poland

Location

Related Publications (1)

  • 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.

    PMID: 28284477DERIVED

MeSH Terms

Conditions

Constipation

Condition Hierarchy (Ancestors)

Signs and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and Symptoms

Limitations and Caveats

Children were recruited in an academic center specialized in the management of children with constipation. Outcomes were evaluated only based on non-validated stool diaries completed by caregivers, except for stool consistency.

Results Point of Contact

Title
Katarzyna Wojtyniak
Organization
The Medical University of Warsaw
wojtyniakkasia@gmail.com
+48 22 317 94 21

Study Officials

  • Hania Szajewska, MD

    Medical University of Warsaw

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

October 30, 2013

First Posted

November 15, 2013

Study Start

November 1, 2013

Primary Completion

November 1, 2016

Study Completion

November 1, 2016

Last Updated

May 17, 2023

Results First Posted

May 17, 2023

Record last verified: 2023-05

Locations

PL(1)