Treatment of Chronic Constipation in Children With Lactobacillus Reuteri

Constipation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01629147
• Other study ID #: SHEBA-11-8960-BW-CTIL
• Status: Not yet recruiting
• Phase: N/A
• First received: June 24, 2012
• Last updated: May 21, 2014
• Start date: July 2014
• Est. completion date: September 2016

Study information

• Verified date: May 2014
• Source: Sheba Medical Center
• Contact: Batia Weiss, MD
• Phone: 972526666315
• Email: weissb[@]sheba.health.gov.il
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: September 2016
• Est. primary completion date: September 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 4 Years to 10 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Constipation

Intervention

Dietary Supplement:
• Biogaia
5 drops containing Lactobacillus reuteri Protectis

Other:
• Placebo
5 drops

Locations

Country	Name	City	State
Israel	Sheba medical center	Ramat Gan	Tel Hashomer
Israel	Asaf Harofe medical center	Zrifin

Sponsors (2)

Lead Sponsor	Collaborator
Sheba Medical Center	Assaf-Harofeh Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Increase in stool number/week to at least 4 bowel movements	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.	8 weeks	No
Secondary	Improved stool consistency- measured by Bristol Stool Scale		4 weeks	No
Secondary	Improved defecation pain - measured as reduction of a pain score of 0-4 at clinic visits 2 and 4.		4 -8 weeks	No