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Effect of Probiotics in Childhood Abdominal Pain

This study is not yet open for participant recruitment.
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
History of Changes
  Purpose

The purpose of this study is to assess the effect of probiotics in childhood recurrent abdominal pain.


Condition Intervention
Abdominal Pain
 Dietary Supplement: Probiotics
Dietary Supplement: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver)
Primary Purpose: Treatment
Official Title: The Effect of Probiotics in Childhood Abdominal Pain

Resource links provided by NLM:

MedlinePlus related topics: Abdominal Pain
U.S. FDA Resources

Further study details as provided by Soroka University Medical Center:

Primary Outcome Measures:
  • Relief of abdominal pain [ Time Frame: Six weeks ] [ Designated as safety issue: No ]
    Based on patient questionnaire


Secondary Outcome Measures:
  • Side effects [ Time Frame: Six weeks ] [ Designated as safety issue: Yes ]
    Any clinical side effect of probiotics reported by the subjects.


Estimated Enrollment: 100
Study Start Date: January 2013
Estimated Study Completion Date: June 2016
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Probiotics supplementation
Supplementation by probiotics for 6 weeks
 Dietary Supplement: Probiotics
Daily oral supplementation for six weeks
Other Name: probiotic agent
Placebo Comparator: Placebo
Supplementation of placebo
 Dietary Supplement: Placebo
Placebo administration
Other Name: placebo tablets

Detailed Description:

Prospective randomized double-blind study.

  Eligibility

Ages Eligible for Study:   5 Years to 15 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Healthy children

Exclusion Criteria:

  • Any chronic or organic illness
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01180556

Contacts
Contact: Zvi Weizman, MD +972-8-6400310 wzvi@bgu.ac.il

Locations
Israel
Soroka Medical Center
Beer-Sheva, Israel, 84101
Sponsors and Collaborators
Soroka University Medical Center
Investigators
Principal Investigator: Zvi Weizman, MD Soroka Medical Center
  More Information

No publications provided

Responsible Party: Soroka University Medical Center
ClinicalTrials.gov Identifier: NCT01180556     History of Changes
Other Study ID Numbers: Sor493009ctil, 4930
Study First Received: August 9, 2010
Last Updated: June 13, 2012
Health Authority: Israel: Ministry of Health

Keywords provided by Soroka University Medical Center:
childhood
abdominal pain
probiotics

Additional relevant MeSH terms:
Abdominal Pain
Pain
Signs and Symptoms
Signs and Symptoms, Digestive

ClinicalTrials.gov processed this record on June 18, 2013