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Lactobacillus Reuteri in Children With Constipation

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2012 by Children's Memorial Health Institute, Poland.
Recruitment status was  Recruiting
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

July 5, 2011
April 1, 2012
July 2011
April 2012   (final data collection date for primary outcome measure)
Number of bowel movement per week, without fecal incontinence [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01388712 on ClinicalTrials.gov Archive Site
  • 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 ]
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.
Not Provided
Not Provided
 
Lactobacillus Reuteri in Children With Constipation
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

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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Functional Constipation
  • 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).
  • Dietary Supplement: Placebo
    Patients, who met inclusion criteria, will receive an identical to probiotic looking and tasting placebo.
  • Placebo Comparator: Placebo
    Intervention: Dietary Supplement: Placebo
  • Active Comparator: Probiotics
    Lactobacillus reuteri DSM 17938
    Intervention: Dietary Supplement: Lactobacillus reuteri DSM 17938
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
128
December 2012
April 2012   (final data collection date for primary outcome measure)

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
Both
3 Years to 7 Years
No
Contact: Jaroslaw Kierkus, Ph.D. +48 228157384
Poland
 
NCT01388712
CZDGA23.01.2011
Yes
JAROSLAW KIERKUS, Children's Memorial Health Institute, Poland
Children's Memorial Health Institute, Poland
Not Provided
Study Chair: Jaroslaw Kierkus, Ph.D. Children's Memorial Health Institute, Poland
Principal Investigator: Agnieszka Wegner, M.D. Children's Memorial Health Institute, Poland
Children's Memorial Health Institute, Poland
April 2012

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