Clinical Trial: Treatment of Chronic Constipation in Children With Lactobacillus Reuteri

Study Status: Completed
Recruit Status: Unknown status
Study Type: Interventional

Official Title: Treatment of Chronic Constipation in Children With Lactobacillus Reuteri (Biogaia): A Prospective Placebo-controlled Trial

Brief Summary: Lactobacillus reuteri (Biogaia) may be beneficial for treatment of chronic constipation in children 4-10 years of age.

Detailed Summary:

Functional chronic constipation is very common in childhood and is responsible for 20% of the clinic visits in pediatric gastroenterology. Constipation is defined by the Rome III criteria. The symptoms are difficult to treat in part of the patients and cause frustration to the patient and family.

Probiotics are increasingly used in the treatment of functional gastrointestinal disorders, including chronic constipation in adults and children. A recent study revealed that the administration of Lactobacillus reuteri had a positive effect on bowel frequency in infants with chronic constipation.

The study goal is to evaluate Lactobacillus reuteri (Biogaia) for treatment of chronic constipation in children 4-10 years of age, and to examine the influence of Lactobacillus reuteri (Biogaia) on constipation in different age groups of school aged children between 4-10 yrs of age.


Sponsor: Sheba Medical Center

Current Primary Outcome: Increase in stool number/week to at least 4 bowel movements [ Time Frame: 8 weeks ]

The measurement will be done by phone interview at week 1 and 3, and at clinic visits at week 2 and 4.

A follow-up phone interview after the medication/placebo is stopped, at weeks 6 and 8 post enrolment.



Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Improved stool consistency- measured by Bristol Stool Scale [ Time Frame: 4 weeks ]
  • Improved defecation pain - measured as reduction of a pain score of 0-4 at clinic visits 2 and 4. [ Time Frame: 4 -8 weeks ]


Original Secondary Outcome: Same as current

Information By: Sheba Medical Center

Dates:
Date Received: June 24, 2012
Date Started: July 2014
Date Completion: September 2016
Last Updated: May 21, 2014
Last Verified: May 2014