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Treatment of Chronic Constipation in Children With Lactobacillus Reuteri

Primary Purpose

Constipation

Status
Unknown status
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Biogaia
Placebo
Sponsored by
Sheba Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Constipation focused on measuring Constipation

Eligibility Criteria

4 Years - 10 Years (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Sheba medical center
  • Asaf Harofe medical center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Biogaia

Placebo

Arm Description

5 drops containing Lactobacillus reuteri Protectis

- 5 drops identical in appearance and taste

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Full Information

First Posted
June 24, 2012
Last Updated
May 21, 2014
Sponsor
Sheba Medical Center
Collaborators
Assaf-Harofeh Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT01629147
Brief Title
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

2. Study Status

Record Verification Date
May 2014
Overall Recruitment Status
Unknown status
Study Start Date
July 2014 (undefined)
Primary Completion Date
September 2015 (Anticipated)
Study Completion Date
September 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sheba Medical Center
Collaborators
Assaf-Harofeh Medical Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Constipation
Keywords
Constipation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Biogaia
Arm Type
Experimental
Arm Description
5 drops containing Lactobacillus reuteri Protectis
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
- 5 drops identical in appearance and taste
Intervention Type
Dietary Supplement
Intervention Name(s)
Biogaia
Intervention Description
5 drops containing Lactobacillus reuteri Protectis
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
5 drops
Primary Outcome Measure Information:
Title
Increase in stool number/week to at least 4 bowel movements
Description
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.
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Improved stool consistency- measured by Bristol Stool Scale
Time Frame
4 weeks
Title
Improved defecation pain - measured as reduction of a pain score of 0-4 at clinic visits 2 and 4.
Time Frame
4 -8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
10 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. 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). 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. Parents or tutors signed informed consent to the child's participation the study. Willingness to comply with the protocol.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Batia Weiss, MD
Phone
972526666315
Email
weissb@sheba.health.gov.il
Facility Information:
Facility Name
Sheba medical center
City
Ramat Gan
State/Province
Tel Hashomer
ZIP/Postal Code
52625
Country
Israel
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Batia Weiss, MD
Phone
972526666315
Email
weissb@sheba.health.gov.il
First Name & Middle Initial & Last Name & Degree
Batia Weiss, MD
Facility Name
Asaf Harofe medical center
City
Zrifin
Country
Israel
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Efrat Broide, MD
Email
efibroide@yahoo.com

12. IPD Sharing Statement

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Treatment of Chronic Constipation in Children With Lactobacillus Reuteri

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