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The Effect of Bifidobacterium Lactis and Inulin on Functional Constipation

NCT ID: NCT01913665

Last Updated: 2013-08-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-09-30

Brief Summary

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

Detailed Description

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Conditions

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Functional Constipation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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B.Lactis

children with functional constipation

Group Type ACTIVE_COMPARATOR

B.lactis

Intervention Type OTHER

Inulin

children with functional constipation

Group Type ACTIVE_COMPARATOR

Inulin

Intervention Type OTHER

B.Lactis+ınulin

children with functional constipation

Group Type ACTIVE_COMPARATOR

B.Lactis +Inulin

Intervention Type OTHER

plasebo

children with functional constipation

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Interventions

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B.lactis

Intervention Type OTHER

Inulin

Intervention Type OTHER

B.Lactis +Inulin

Intervention Type OTHER

Placebo

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

4 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Eskisehir Osmangazi University

OTHER

Sponsor Role lead

Responsible Party

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Makbule Eren

Associate professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Central Contacts

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Makbule Eren, Associate professor

Role: CONTACT

Phone: 00902222392979

Email: [email protected]

Other Identifiers

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not defined yet

Identifier Type: -

Identifier Source: org_study_id