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Lactobacillus Reuteri in Children With Constipation

This study is currently recruiting participants.
Verified April 2012 by Children's Memorial Health Institute, Poland
Sponsor:
Information provided by (Responsible Party):
JAROSLAW KIERKUS, Children's Memorial Health Institute, Poland
ClinicalTrials.gov Identifier:
NCT01388712
First received: July 5, 2011
Last updated: April 1, 2012
Last verified: April 2012
History of Changes
  Purpose

The most common cause of children chronic constipation is functional disorders. Functional constipation is diagnosed after excluding organic causes of constipation (anatomical, neurological, endocrinological) and identification of two symptoms defined by the Rome III criteria. There could be low number of bowel movements (below three times a week), defecation pain, fecal incontinence (once a week), stool consistency or occurrence of large diameter stools. The treatment is change of diet, defecation training and application of laxatives.

The probiotics are defined as living microorganisms, which provided in a proper doses should result in beneficial effect on a host health. The assessment of its characteristic is related to strain of bacteria affiliation.

Taking into the consideration that patients with constipation may experience microflora intestine disorders, using the probiotics can have the positive impact on process of treating this disease. The additional reason for using the probiotics during the constipation treatment is an influence of probiotics on movement of the alimentary canal.

In spite of proved effectiveness of some probiotics' strains further research are required, because clinical significance is ambiguous and the effect is confirmed among patients with short medical history. That's way the further analysis of probiotic Lactobacillus reuteri DSM 17938, which was successful treatment method of chronic constipation amongst children (infants) should be performed.

The primary aim of the study is the assessment of Lactobacillus reuteri DSM 17938 efficacy, provided with macrogol (Forlax), as treatment of constipation in 3-7 years old children. The baseline of estimation is the frequency comparison of bowel movement in children belonging into two groups: Lactobacillus reuteri treatment and placebo.

The secondary aim of the study is the assessment of frequency the additional symptoms connected with defecation disorders: such as: number of pain episodes during defecation, the intensity of pain, number of hard stools, number of fecal incontinence per week, number of macrogol (Forlax) pockets used.

The investigators believe that constipation treatment (laxatives- macrogol) with Lactobacillus reuteri has better efficacy that the same treatment without Lactobacillus reuteri in 3-7 years old children with medical history of chronic constipation.


Condition Intervention Phase
Functional Constipation
 Dietary Supplement: Lactobacillus reuteri DSM 17938
Dietary Supplement: Placebo
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: The Assessment of Lactobacillus Reuteri Efficacy, Provided With Forlax, as Treatment of Incurable Constipation in Children 3-7 Years. Double Blind, Placebo-controlled, Randomized and Multicenter Trial

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Children's Memorial Health Institute, Poland:

Primary Outcome Measures:
  • Number of bowel movement per week, without fecal incontinence [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • The number of bowel movements per week [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
    Other secondary items are: the number of pain episodes during defecation per week, the number of hard stools, the number of fecal incontinence per week, the number of patients who have to change amount of drug or use of enema.

  • The number of pain episodes during defecation per week, [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
  • The number of hard stools [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
  • The number of fecal incontinence per week [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
  • The number of patients who have to change amount of drug [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
  • The number of patients who have to change use of enema. [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 128
Study Start Date: July 2011
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo Dietary Supplement: Placebo
Patients, who met inclusion criteria, will receive an identical to probiotic looking and tasting placebo.
Active Comparator: Probiotics
Lactobacillus reuteri DSM 17938
 Dietary Supplement: Lactobacillus reuteri DSM 17938
Patients, who met inclusion criteria, will receive following medicaments during 8 weeks: Lactobacillus reuteri DSM 17938 in form of chewing (one tablets containing 10^8CFU).

  Eligibility

Ages Eligible for Study:   3 Years to 7 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Children 3-7 years old
  • Occurrence less than three bowel movement per week
  • Medical history from at least two months]
  • Ineffective laxative treatment at least two months
  • The parents approval for child participation in the study and for the treatment

Exclusion Criteria:

  • Well-known, organic cause of constipation (i.e. hypothyroidism, Hirschprung disease, cystis fibrosis)
  • Anatomic defects of the alimentary canal
  • The surgery of the alimentary canal in the past
  • Treatment of antibiotics/probiotics during last two weeks before start of the study
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01388712

Contacts
Contact: Jaroslaw Kierkus, Ph.D. +48 228157384

Locations
Poland
ChildrensMHIPoland Recruiting
Warsaw, Poland, 04-730
Contact: Jaroslaw Kierkus, Ph.D.     +48 228157384        
Sponsors and Collaborators
Children's Memorial Health Institute, Poland
Investigators
Study Chair: Jaroslaw Kierkus, Ph.D. Children's Memorial Health Institute, Poland
Principal Investigator: Agnieszka Wegner, M.D. Children's Memorial Health Institute, Poland
  More Information

No publications provided

Responsible Party: JAROSLAW KIERKUS, Ph.D., Children's Memorial Health Institute, Poland
ClinicalTrials.gov Identifier: NCT01388712     History of Changes
Other Study ID Numbers: CZDGA23.01.2011
Study First Received: July 5, 2011
Last Updated: April 1, 2012
Health Authority: Poland: Ethics Committee

Keywords provided by Children's Memorial Health Institute, Poland:
Probiotics
constipation
children

Additional relevant MeSH terms:
Constipation
Signs and Symptoms, Digestive
Signs and Symptoms

ClinicalTrials.gov processed this record on May 16, 2013