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Treatment of Chronic Constipation in Children With Lactobacillus Reuteri

This study is not yet open for participant recruitment.
Verified June 2012 by Sheba Medical Center
Sponsor:
Collaborator:
Assaf-Harofeh Medical Center
Information provided by (Responsible Party):
Batia Weiss, Sheba Medical Center
ClinicalTrials.gov Identifier:
NCT01629147
First received: June 24, 2012
Last updated: June 26, 2012
Last verified: June 2012
History of Changes
  Purpose

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


Condition Intervention
Constipation
 Dietary Supplement: Biogaia
Other: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver)
Primary Purpose: Treatment
Official Title: Treatment of Chronic Constipation in Children With Lactobacillus Reuteri (Biogaia): A Prospective Placebo-controlled Trial

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Sheba Medical Center:

Primary Outcome Measures:
  • Increase in stool number/week to at least 4 bowel movements [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

    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 [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
  • Improved defecation pain - measured as reduction of a pain score of 0-4 at clinic visits 2 and 4. [ Time Frame: 4 -8 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 40
Study Start Date: September 2012
Estimated Study Completion Date: September 2015
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

Ages Eligible for Study:   4 Years to 10 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01629147

Contacts
Contact: Batia Weiss, MD 972526666315 weissb@sheba.health.gov.il

Locations
Israel
Sheba medical center Not yet recruiting
Ramat Gan, Tel Hashomer, Israel, 52625
Contact: Batia Weiss, MD     972526666315     weissb@sheba.health.gov.il    
Principal Investigator: Batia Weiss, MD            
Asaf Harofe medical center Not yet recruiting
Zrifin, Israel
Contact: Efrat Broide, MD         efibroide@yahoo.com    
Sponsors and Collaborators
Sheba Medical Center
Assaf-Harofeh Medical Center
  More Information

No publications provided

Responsible Party: Batia Weiss, Director, Division of Pediatric Gastroenterology and Nutrition, Sheba Medical Center
ClinicalTrials.gov Identifier: NCT01629147     History of Changes
Other Study ID Numbers: SHEBA-11-8960-BW-CTIL
Study First Received: June 24, 2012
Last Updated: June 26, 2012
Health Authority: Israel: Ministry of Health

Keywords provided by Sheba Medical Center:
Constipation

Additional relevant MeSH terms:
Constipation
Signs and Symptoms, Digestive
Signs and Symptoms

ClinicalTrials.gov processed this record on May 19, 2013