Treatment of Chronic Constipation in Children With Lactobacillus Reuteri
1 other identifier
interventional
40
1 country
2
Brief Summary
Lactobacillus reuteri (Biogaia) may be beneficial for treatment of chronic constipation in children 4-10 years of age.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jul 2014
Typical duration for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 24, 2012
CompletedFirst Posted
Study publicly available on registry
June 27, 2012
CompletedStudy Start
First participant enrolled
July 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2016
CompletedMay 22, 2014
May 1, 2014
1.2 years
June 24, 2012
May 21, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (2)
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
Study Arms (2)
Biogaia
EXPERIMENTAL5 drops containing Lactobacillus reuteri Protectis
Placebo
PLACEBO COMPARATOR\- 5 drops identical in appearance and taste
Interventions
Eligibility Criteria
You may qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Sheba Medical Centerlead
- Assaf-Harofeh Medical Centercollaborator
Study Sites (2)
Sheba medical center
Ramat Gan, Tel Hashomer, 52625, Israel
Asaf Harofe medical center
Zrifin, Israel
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, CARE PROVIDER
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Director, Division of Pediatric Gastroenterology and Nutrition
Study Record Dates
First Submitted
June 24, 2012
First Posted
June 27, 2012
Study Start
July 1, 2014
Primary Completion
September 1, 2015
Study Completion
September 1, 2016
Last Updated
May 22, 2014
Record last verified: 2014-05