Effect of Probiotics in Childhood Abdominal Pain

Not Applicable

Completed

• Conditions: Abdominal Pain
• Interventions: Dietary Supplement: Probiotics; Dietary Supplement: Placebo

• Registration Number: NCT01180556
• Lead Sponsor: Soroka University Medical Center

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.

Study Timeline

• Study First Submitted: 2010-08-09
• Study First Submitted QC: 2010-08-11
• Study First Posted: 2010-08-12
• Study Start: 2011-03
• Primary Completion: 2013-10
• Study Completion: 2013-10
• Status Verified: 2016-03
• Last Update Submitted: 2016-03-27
• Last Update Posted: 2016-03-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 101

Inclusion Criteria

• Healthy children

Exclusion Criteria

• Any chronic or organic illness

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Probiotics supplementation	Probiotics	Supplementation by probiotics for 4 weeks
Placebo	Placebo	Supplementation of placebo for 4 weeks

Primary Outcome Measures

Name	Time	Method
Frequency and intensity of abdominal pain	Eight weeks	Number of pain episodes and pain intensity based on a visual scale

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Soroka Medical Center; 🇮🇱 Beer-Sheva, Israel