Clinical trial NCT01629147: Treatment of Chronic Constipation in Children With Lactobacillus Reuteri
Official title: Treatment of Chronic Constipation in Children With Lactobacillus Reuteri (Biogaia): A Prospective Placebo-controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Constipation
Keywords: Constipation
Lead sponsor: Sheba Medical Center
Sponsor class: OTHER_GOV
Collaborators: name: Assaf-Harofeh Medical Center
First posted: 2012-06-27
Enrollment: 40
Sex: ALL
Minimum age (years): 4
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

1. Patients 4-10 years old with no underlying chronic illnesses or anatomical abnormalities of the GI tract, with parents agreeing to participate in the study and signing an informed consent.
2. Chronic constipation defined by the Rome III criteria (Must include 2 or more of the following in a child with a developmental age of at least 4 years with insufficient criteria for diagnosis of IBS: 1. Two or fewer defecations in the toilet per week. 2. At least 1 episode of fecal incontinence per week. 3. History of retentive posturing or excessive volitional stool retention. 4. History of painful or hard bowel movements. 5. Presence of a large fecal mass in the rectum. 6. History of large diameter stools that may obstruct the toilet).
3. Normal Thyroid function test and negative celiac serology (IgA or IgG in patients with IgA deficiency), and no evidence of elevated RAST test for milk.
4. Parents or tutors signed informed consent to the child's participation the study.
5. Willingness to comply with the protocol.

Primary outcomes:
measure: Increase in stool number/week to at least 4 bowel movements
timeFrame: 8 weeks
Secondary outcomes:
measure: Improved stool consistency- measured by Bristol Stool Scale
timeFrame: 4 weeks
measure: Improved defecation pain - measured as reduction of a pain score of 0-4 at clinic visits 2 and 4.
timeFrame: 4 -8 weeks
Other outcomes:
Locations:
city: Ramat Gan
country: Israel
facility: Sheba medical center
state: Tel Hashomer
city: Zrifin
country: Israel
facility: Asaf Harofe medical center
Study officials:
References: