Effect of Probiotics in Childhood Abdominal Pain

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Soroka University Medical Center
ClinicalTrials.gov Identifier:
NCT01180556
First received: August 9, 2010
Last updated: March 27, 2016
Last verified: March 2016
  Purpose
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.

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, Investigator, Outcomes Assessor)
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:
  • Frequency and intensity of abdominal pain [ Time Frame: Eight weeks ] [ Designated as safety issue: No ]
    Number of pain episodes and pain intensity based on a visual scale


Secondary Outcome Measures:
  • School absenteeism [ Time Frame: Eight weeks ] [ Designated as safety issue: No ]
    Number of patients with school absenteeism

  • Other gastrointestinal symptoms [ Time Frame: Eight weeks ] [ Designated as safety issue: No ]
    Any gastrointestinal symptom such as nausea, vomiting, diarrhea, bloating

  • Adverse effects related to treatment [ Time Frame: Eight weeks ] [ Designated as safety issue: Yes ]
    Any adverse effects related to the probiotic supplementation


Enrollment: 101
Study Start Date: March 2011
Study Completion Date: October 2013
Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Probiotics supplementation
Supplementation by probiotics for 4 weeks
Dietary Supplement: Probiotics
Daily oral supplementation for four weeks
Other Name: probiotic agent, L. reuteri
Placebo Comparator: Placebo
Supplementation of placebo for 4 weeks
Dietary Supplement: Placebo
Placebo administration
Other Name: placebo tablets

Detailed Description:
Prospective randomized double-blind placebo-controlled trial.
  Eligibility

Ages Eligible for Study:   6 Years to 15 Years   (Child)
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

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

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: March 27, 2016
Health Authority: Israel: Ministry of Health
Individual Participant Data  
Plan to Share IPD: Undecided

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

Additional relevant MeSH terms:
Abdominal Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Signs and Symptoms, Digestive

ClinicalTrials.gov processed this record on July 21, 2016