Effect of Probiotics in Childhood Abdominal Pain

March 27, 2016 updated by: Soroka University Medical Center

The Effect of Probiotics in Childhood Abdominal Pain

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Prospective randomized double-blind placebo-controlled trial.

Study Type

Interventional

Enrollment (Actual)

101

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.

Study Locations

  • Israel
      • Beer-Sheva, Israel, 84101
        • Soroka Medical Center

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

6 years to 15 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Healthy children

Exclusion Criteria:

  • Any chronic or organic illness

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
Experimental: Probiotics supplementation
Supplementation by probiotics for 4 weeks
Dietary supplement: Probiotics
Daily oral supplementation for four weeks
Other Names:
  • probiotic agent, L. reuteri
Placebo Comparator: Placebo
Supplementation of placebo for 4 weeks
Dietary supplement: Placebo
Placebo administration
Other Names:
  • placebo tablets

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Frequency and intensity of abdominal pain
Time Frame: Eight weeks
Number of pain episodes and pain intensity based on a visual scale
Eight weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
School absenteeism
Time Frame: Eight weeks
Number of patients with school absenteeism
Eight weeks
Other gastrointestinal symptoms
Time Frame: Eight weeks
Any gastrointestinal symptom such as nausea, vomiting, diarrhea, bloating
Eight weeks
Adverse effects related to treatment
Time Frame: Eight weeks
Any adverse effects related to the probiotic supplementation
Eight weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Soroka University Medical Center

Investigators

  • Principal Investigator: Zvi Weizman, MD, Soroka University Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

March 1, 2011

Primary Completion (Actual)

October 1, 2013

Study Completion (Actual)

October 1, 2013

Study Registration Dates

First Submitted

August 9, 2010

First Submitted That Met QC Criteria

August 11, 2010

First Posted (Estimate)

August 12, 2010

Study Record Updates

Last Update Posted (Estimate)

March 29, 2016

Last Update Submitted That Met QC Criteria

March 27, 2016

Last Verified

March 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Sor493009ctil
  • 4930 (Other Identifier: SMC)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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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