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Treatment of Chronic Constipation in Children With Lactobacillus Reuteri

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified May 2014 by Sheba Medical Center.
Recruitment status was:  Not yet recruiting
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: May 21, 2014
Last verified: May 2014
  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:


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: July 2014
Estimated Study Completion Date: September 2016
Estimated Primary Completion Date: September 2015 (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   (Child)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01629147

Locations
Israel
Sheba medical center
Ramat Gan, Tel Hashomer, Israel, 52625
Asaf Harofe medical center
Zrifin, Israel
Sponsors and Collaborators
Sheba Medical Center
Assaf-Harofeh Medical Center
  More Information

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: May 21, 2014
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 December 07, 2016