Clinical Trial: Effect of Probiotics in Childhood Abdominal Pain
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: The Effect of Probiotics in Childhood Abdominal Pain
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 Summary: Prospective randomized double-blind placebo-controlled trial.
Sponsor: Soroka University Medical Center
Current Primary Outcome: Frequency and intensity of abdominal pain [ Time Frame: Eight weeks ]
Original Primary Outcome: Relief of abdominal pain [ Time Frame: Six weeks ]
Current Secondary Outcome:
- School absenteeism [ Time Frame: Eight weeks ]Number of patients with school absenteeism
- Other gastrointestinal symptoms [ Time Frame: Eight weeks ]Any gastrointestinal symptom such as nausea, vomiting, diarrhea, bloating
- Adverse effects related to treatment [ Time Frame: Eight weeks ]Any adverse effects related to the probiotic supplementation
Original Secondary Outcome: Side effects [ Time Frame: Six weeks ]
Information By: Soroka University Medical Center
Dates:
Date Received: August 9, 2010
Date Started: March 2011
Date Completion:
Last Updated: March 27, 2016
Last Verified: March 2016