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NCT01180556 Clinical Trial

Effect of Probiotics in Childhood Abdominal Pain

Abdominal Pain Clinical Trial

Official title:
The Effect of Probiotics in Childhood Abdominal Pain

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01180556
Other study ID # Sor493009ctil
Secondary ID 4930
Status Completed
Phase N/A
First received August 9, 2010
Last updated March 27, 2016
Start date March 2011
Est. completion date October 2013

Study information
Verified date March 2016
Source Soroka University Medical Center
Contact n/a
Is FDA regulated No
Health authority Israel: Ministry of Health
Study type Interventional

Clinical Trial 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.

Description:

Prospective randomized double-blind placebo-controlled trial.

Recruitment information / eligibility
Status Completed
Enrollment 101
Est. completion date October 2013
Est. primary completion date October 2013
Accepts healthy volunteers No
Gender Both
Age group 6 Years to 15 Years
Eligibility Inclusion Criteria:

- Healthy children

Exclusion Criteria:

- Any chronic or organic illness

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Dietary Supplement:
• Probiotics
Daily oral supplementation for four weeks
• Placebo
Placebo administration

Locations
Country Name City State
Israel Soroka Medical Center Beer-Sheva

Sponsors (1)
Lead Sponsor Collaborator
Soroka University Medical Center

Country where clinical trial is conducted

Israel, 

Outcome
Type Measure Description Time frame Safety issue
Primary Frequency and intensity of abdominal pain Number of pain episodes and pain intensity based on a visual scale Eight weeks No
Secondary School absenteeism Number of patients with school absenteeism Eight weeks No
Secondary Other gastrointestinal symptoms Any gastrointestinal symptom such as nausea, vomiting, diarrhea, bloating Eight weeks No
Secondary Adverse effects related to treatment Any adverse effects related to the probiotic supplementation Eight weeks Yes
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