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Effect of Probiotics in Childhood Abdominal Pain

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01180556
First Posted: August 12, 2010
Last Update Posted: March 29, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Soroka University Medical Center
August 9, 2010
August 12, 2010
March 29, 2016
March 2011
October 2013   (Final data collection date for primary outcome measure)
Frequency and intensity of abdominal pain [ Time Frame: Eight weeks ]
Number of pain episodes and pain intensity based on a visual scale
Relief of abdominal pain [ Time Frame: Six weeks ]
Based on patient questionnaire
Complete list of historical versions of study NCT01180556 on ClinicalTrials.gov Archive Site
  • 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
Side effects [ Time Frame: Six weeks ]
Any clinical side effect of probiotics reported by the subjects.
Not Provided
Not Provided
 
Effect of Probiotics in Childhood Abdominal Pain
The Effect of Probiotics in Childhood Abdominal Pain
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.
Prospective randomized double-blind placebo-controlled trial.
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Abdominal Pain
  • Dietary Supplement: Probiotics
    Daily oral supplementation for four weeks
    Other Name: probiotic agent, L. reuteri
  • Dietary Supplement: Placebo
    Placebo administration
    Other Name: placebo tablets
  • Experimental: Probiotics supplementation
    Supplementation by probiotics for 4 weeks
    Intervention: Dietary Supplement: Probiotics
  • Placebo Comparator: Placebo
    Supplementation of placebo for 4 weeks
    Intervention: Dietary Supplement: Placebo
Weizman Z, Abu-Abed J, Binsztok M. Lactobacillus reuteri DSM 17938 for the Management of Functional Abdominal Pain in Childhood: A Randomized, Double-Blind, Placebo-Controlled Trial. J Pediatr. 2016 Jul;174:160-164.e1. doi: 10.1016/j.jpeds.2016.04.003. Epub 2016 May 4.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
101
October 2013
October 2013   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Healthy children

Exclusion Criteria:

  • Any chronic or organic illness
Sexes Eligible for Study: All
6 Years to 15 Years   (Child)
No
Contact information is only displayed when the study is recruiting subjects
Israel
 
 
NCT01180556
Sor493009ctil
4930 ( Other Identifier: SMC )
Yes
Not Provided
Plan to Share IPD: Undecided
Soroka University Medical Center
Soroka University Medical Center
Not Provided
Principal Investigator: Zvi Weizman, MD Soroka Medical Center
Soroka University Medical Center
March 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP