Effect of Probiotics in Childhood Abdominal Pain

NCT ID: NCT01180556

Last Updated: 2016-03-29

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

COMPLETED

Clinical Phase

NA

Total Enrollment

101 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-03-31

Study Completion Date

2013-10-31

Brief Summary

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The purpose of this study is to assess the effect of probiotics in childhood recurrent abdominal pain. Patients will be randomly assigned to receive L. reuteri or placebo for 4 weeks with a follow up phase of additional 4 weeks.

Detailed Description

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Prospective randomized double-blind placebo-controlled trial.

Conditions

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Abdominal Pain

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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Probiotics supplementation

Supplementation by probiotics for 4 weeks

Group Type EXPERIMENTAL

Probiotics

Intervention Type DIETARY_SUPPLEMENT

Daily oral supplementation for four weeks

Placebo

Supplementation of placebo for 4 weeks

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DIETARY_SUPPLEMENT

Placebo administration

Interventions

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Probiotics

Daily oral supplementation for four weeks

Intervention Type DIETARY_SUPPLEMENT

Placebo

Placebo administration

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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probiotic agent, L. reuteri placebo tablets

Eligibility Criteria

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Inclusion Criteria

* Healthy children

Exclusion Criteria

* Any chronic or organic illness
Minimum Eligible Age

6 Years

Maximum Eligible Age

15 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Soroka University Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Zvi Weizman, MD

Role: PRINCIPAL_INVESTIGATOR

Soroka University Medical Center

Locations

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Soroka Medical Center

Beersheba, , Israel

Site Status

Countries

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Israel

References

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Weizman Z, Abu-Abed J, Binsztok M. Lactobacillus reuteri DSM 17938 for the Management of Functional Abdominal Pain in Childhood: A Randomized, Double-Blind, Placebo-Controlled Trial. J Pediatr. 2016 Jul;174:160-164.e1. doi: 10.1016/j.jpeds.2016.04.003. Epub 2016 May 4.

Reference Type DERIVED
PMID: 27156182 (View on PubMed)

Other Identifiers

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4930

Identifier Type: OTHER

Identifier Source: secondary_id

Sor493009ctil

Identifier Type: -

Identifier Source: org_study_id

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