Constipation Clinical Trial
Official title:
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.
Status | Not yet recruiting |
Enrollment | 40 |
Est. completion date | September 2016 |
Est. primary completion date | September 2015 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 4 Years to 10 Years |
Eligibility |
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. |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Israel | Sheba medical center | Ramat Gan | Tel Hashomer |
Israel | Asaf Harofe medical center | Zrifin |
Lead Sponsor | Collaborator |
---|---|
Sheba Medical Center | Assaf-Harofeh Medical Center |
Israel,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | No |
Secondary | Improved stool consistency- measured by Bristol Stool Scale | 4 weeks | No | |
Secondary | Improved defecation pain - measured as reduction of a pain score of 0-4 at clinic visits 2 and 4. | 4 -8 weeks | No |
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