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 ]

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


Original Primary Outcome: Relief of abdominal pain [ Time Frame: Six weeks ]

Based on patient questionnaire


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 ]

Any clinical side effect of probiotics reported by the subjects.


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