Treatment of Chronic Constipation in Children With Lactobacillus Reuteri

Not Applicable

• Conditions: Constipation
• Interventions: Other: Placebo; Dietary Supplement: Biogaia

• Registration Number: NCT01629147
• Lead Sponsor: Sheba Medical Center

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.

Study Timeline

• Study First Submitted: 2012-06-24
• Study First Submitted QC: 2012-06-26
• Study First Posted: 2012-06-27
• Status Verified: 2014-05
• Last Update Submitted: 2014-05-21
• Last Update Posted: 2014-05-22
• Study Start: 2014-07
• Primary Completion: 2015-09
• Study Completion: 2016-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

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.

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	- 5 drops identical in appearance and taste
Biogaia	Biogaia	5 drops containing Lactobacillus reuteri Protectis

Primary Outcome Measures

Name	Time	Method
Increase in stool number/week to at least 4 bowel movements	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.

Secondary Outcome Measures

Name	Time	Method
Improved stool consistency- measured by Bristol Stool Scale	4 weeks
Improved defecation pain - measured as reduction of a pain score of 0-4 at clinic visits 2 and 4.	4 -8 weeks

Trial Locations

Locations (2)

Sheba medical center; 🇮🇱 Ramat Gan, Tel Hashomer, Israel

Asaf Harofe medical center; 🇮🇱 Zrifin, Israel