Treatment of Chronic Constipation in Children With Lactobacillus Reuteri

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

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

Study Overview

• Status: Unknown
• Conditions: Constipation
• Intervention / Treatment: Dietary supplement: Biogaia; Other: Placebo

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 Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Batia Weiss, MD; Phone Number: 972526666315; Email: weissb@sheba.health.gov.il

Study Locations

• Israel
  • Zrifin, Israel
    • Asaf Harofe Medical Center
    • Contact: Efrat Broide, MD; Email: efibroide@yahoo.com
  • Tel Hashomer
    • Ramat Gan, Tel Hashomer, Israel, 52625
      • Sheba Medical Center
      • Contact: Batia Weiss, MD; Phone Number: 972526666315; Email: weissb@sheba.health.gov.il
      • Principal Investigator: Batia Weiss, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 4 years to 10 years (CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Biogaia; 5 drops containing Lactobacillus reuteri Protectis	Dietary supplement: Biogaia; 5 drops containing Lactobacillus reuteri Protectis
PLACEBO_COMPARATOR: Placebo; - 5 drops identical in appearance and taste	Other: Placebo; 5 drops

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Sheba Medical Center
• Collaborators: Assaf-Harofeh Medical Center

Study record dates

Study Major Dates

• Study Start: July 1, 2014
• Primary Completion (ANTICIPATED): September 1, 2015
• Study Completion (ANTICIPATED): September 1, 2016

Study Registration Dates

• First Submitted: June 24, 2012
• First Submitted That Met QC Criteria: June 26, 2012
• First Posted (ESTIMATE): June 27, 2012

Study Record Updates

• Last Update Posted (ESTIMATE): May 22, 2014
• Last Update Submitted That Met QC Criteria: May 21, 2014
• Last Verified: May 1, 2014

More Information

Terms related to this study

• Keywords: Constipation
• Additional Relevant MeSH Terms: Signs and Symptoms, Digestive; Constipation
• Other Study ID Numbers: SHEBA-11-8960-BW-CTIL