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Effect of Probiotics in Childhood Abdominal Pain

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified June 2012 by Soroka University Medical Center
Sponsor:
Information provided by (Responsible Party):
Soroka University Medical Center
ClinicalTrials.gov Identifier:
NCT01180556
First received: August 9, 2010
Last updated: June 13, 2012
Last verified: June 2012

August 9, 2010
June 13, 2012
January 2013
December 2015   (final data collection date for primary outcome measure)
Relief of abdominal pain [ Time Frame: Six weeks ] [ Designated as safety issue: No ]
Based on patient questionnaire
Same as current
Complete list of historical versions of study NCT01180556 on ClinicalTrials.gov Archive Site
Side effects [ Time Frame: Six weeks ] [ Designated as safety issue: Yes ]
Any clinical side effect of probiotics reported by the subjects.
Same as current
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.

Prospective randomized double-blind study.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver)
Primary Purpose: Treatment
Abdominal Pain
  • Dietary Supplement: Probiotics
    Daily oral supplementation for six weeks
    Other Name: probiotic agent
  • Dietary Supplement: Placebo
    Placebo administration
    Other Name: placebo tablets
  • Experimental: Probiotics supplementation
    Supplementation by probiotics for 6 weeks
    Intervention: Dietary Supplement: Probiotics
  • Placebo Comparator: Placebo
    Supplementation of placebo
    Intervention: Dietary Supplement: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
100
June 2016
December 2015   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Healthy children

Exclusion Criteria:

  • Any chronic or organic illness
Both
5 Years to 15 Years
No
Contact: Zvi Weizman, MD +972-8-6400310 wzvi@bgu.ac.il
Israel
 
NCT01180556
Sor493009ctil, 4930
Yes
Soroka University Medical Center
Soroka University Medical Center
Not Provided
Principal Investigator: Zvi Weizman, MD Soroka Medical Center
Soroka University Medical Center
June 2012

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