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Clinical Trials/NCT01180556
NCT01180556
Completed
Not Applicable

The Effect of Probiotics in Childhood Abdominal Pain

Soroka University Medical Center1 site in 1 country101 target enrollmentMarch 2011
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ConditionsAbdominal Pain

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Abdominal Pain
Sponsor
Soroka University Medical Center
Enrollment
101
Locations
1
Primary Endpoint
Frequency and intensity of abdominal pain
Status
Completed
Last Updated
10 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

Overview

Brief Summary

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

Prospective randomized double-blind placebo-controlled trial.

Registry
clinicaltrials.gov
Start Date
March 2011
End Date
October 2013
Last Updated
10 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • •Healthy children

Exclusion Criteria

  • •Any chronic or organic illness

Outcomes

Primary Outcomes

Frequency and intensity of abdominal pain

Time Frame: Eight weeks

Number of pain episodes and pain intensity based on a visual scale

Secondary Outcomes

  • School absenteeism(Eight weeks)
  • Other gastrointestinal symptoms(Eight weeks)
  • Adverse effects related to treatment(Eight weeks)

Study Sites (1)

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