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.

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
Other: B.lactis
Active Comparator: Inulin
children with functional constipation
Other: Inulin
Active Comparator: B.Lactis+ınulin
children with functional constipation
Other: B.Lactis +Inulin
Placebo Comparator: plasebo
children with functional constipation
Other: Placebo

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

Eskisehir Osmangazi University

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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