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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 23, 2014