- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01913665
The Effect of Bifidobacterium Lactis and Inulin on Functional Constipation
August 5, 2013 updated by: Makbule Eren, Eskisehir Osmangazi University
The aim of this study is to asses the effect of Bifidobacterium lactis and Inulin on functional constipation in children
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
200
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Makbule Eren, Associate professor
- Phone Number: 2763,2750,2716 00902222392979
- Email: makbule99@yahoo.com
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
4 years to 18 years (Child, Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- children with functional constipation over 3 years age
- below 18 years of age
Exclusion Criteria:
- Chronic gastrointestinal disease,
- hirschsprung disease,
- celiac disease,
- hypothyroids,
- neurological deficit,
- constipation treatment receiving children will be excluded
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: B.Lactis
children with functional constipation
|
|
Active Comparator: Inulin
children with functional constipation
|
|
Active Comparator: B.Lactis+ınulin
children with functional constipation
|
|
Placebo Comparator: plasebo
children with functional constipation
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
to compare defecation frequency between baseline and 4 th week of treatment
Time Frame: baseline and 4th week of intervention
|
baseline and 4th week of intervention
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2013
Primary Completion (Anticipated)
December 1, 2014
Study Registration Dates
First Submitted
July 30, 2013
First Submitted That Met QC Criteria
July 31, 2013
First Posted (Estimate)
August 1, 2013
Study Record Updates
Last Update Posted (Estimate)
August 7, 2013
Last Update Submitted That Met QC Criteria
August 5, 2013
Last Verified
August 1, 2013
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- not defined yet
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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-
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