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The Effect of Bifidobacterium Lactis and Inulin on Functional Constipation

Primary Purpose

Functional Constipation

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
B.lactis
Inulin
B.Lactis +Inulin
Placebo
Sponsored by
Eskisehir Osmangazi University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Functional Constipation

Eligibility Criteria

4 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm Type

    Active Comparator

    Active Comparator

    Active Comparator

    Placebo Comparator

    Arm Label

    B.Lactis

    Inulin

    B.Lactis+ınulin

    plasebo

    Arm Description

    children with functional constipation

    children with functional constipation

    children with functional constipation

    children with functional constipation

    Outcomes

    Primary Outcome Measures

    to compare defecation frequency between baseline and 4 th week of treatment

    Secondary Outcome Measures

    Full Information

    First Posted
    July 30, 2013
    Last Updated
    August 5, 2013
    Sponsor
    Eskisehir Osmangazi University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01913665
    Brief Title
    The Effect of Bifidobacterium Lactis and Inulin on Functional Constipation
    Official Title
    The Effect of Bifidobacterium Lactis and Inulin on Functional Constipation
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2013
    Overall Recruitment Status
    Unknown status
    Study Start Date
    September 2013 (undefined)
    Primary Completion Date
    December 2014 (Anticipated)
    Study Completion Date
    undefined (undefined)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Eskisehir Osmangazi University

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The aim of this study is to asses the effect of Bifidobacterium lactis and Inulin on functional constipation in children

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Functional Constipation

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    200 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    B.Lactis
    Arm Type
    Active Comparator
    Arm Description
    children with functional constipation
    Arm Title
    Inulin
    Arm Type
    Active Comparator
    Arm Description
    children with functional constipation
    Arm Title
    B.Lactis+ınulin
    Arm Type
    Active Comparator
    Arm Description
    children with functional constipation
    Arm Title
    plasebo
    Arm Type
    Placebo Comparator
    Arm Description
    children with functional constipation
    Intervention Type
    Other
    Intervention Name(s)
    B.lactis
    Intervention Type
    Other
    Intervention Name(s)
    Inulin
    Intervention Type
    Other
    Intervention Name(s)
    B.Lactis +Inulin
    Intervention Type
    Other
    Intervention Name(s)
    Placebo
    Primary Outcome Measure Information:
    Title
    to compare defecation frequency between baseline and 4 th week of treatment
    Time Frame
    baseline and 4th week of intervention

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    4 Years
    Maximum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Makbule Eren, Associate professor
    Phone
    00902222392979
    Ext
    2763,2750,2716
    Email
    makbule99@yahoo.com

    12. IPD Sharing Statement

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    The Effect of Bifidobacterium Lactis and Inulin on Functional Constipation

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