The Effect of Bifidobacterium Lactis and Inulin on Functional Constipation
1 other identifier
interventional
200
0 countries
N/A
Brief Summary
The aim of this study is to asses the effect of Bifidobacterium lactis and Inulin on functional constipation in children
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
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
July 30, 2013
CompletedFirst Posted
Study publicly available on registry
August 1, 2013
CompletedStudy Start
First participant enrolled
September 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2014
CompletedAugust 7, 2013
August 1, 2013
1.2 years
July 30, 2013
August 5, 2013
Conditions
Outcome Measures
Primary Outcomes (1)
to compare defecation frequency between baseline and 4 th week of treatment
baseline and 4th week of intervention
Study Arms (4)
B.Lactis
ACTIVE COMPARATORchildren with functional constipation
Inulin
ACTIVE COMPARATORchildren with functional constipation
B.Lactis+ınulin
ACTIVE COMPARATORchildren with functional constipation
plasebo
PLACEBO COMPARATORchildren with functional constipation
Interventions
Eligibility Criteria
You may qualify if:
- children with functional constipation over 3 years age
- below 18 years of age
You may not qualify if:
- Chronic gastrointestinal disease,
- hirschsprung disease,
- celiac disease,
- hypothyroids,
- neurological deficit,
- constipation treatment receiving children will be excluded
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate professor
Study Record Dates
First Submitted
July 30, 2013
First Posted
August 1, 2013
Study Start
September 1, 2013
Primary Completion
December 1, 2014
Last Updated
August 7, 2013
Record last verified: 2013-08