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Effect of Probiotics in Childhood Abdominal Pain

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ClinicalTrials.gov Identifier: NCT01180556
Recruitment Status : Completed
First Posted : August 12, 2010
Last Update Posted : March 29, 2016
Sponsor:
Information provided by (Responsible Party):
Soroka University Medical Center

Study Description
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Brief Summary:
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 or disease Intervention/treatment Phase
Abdominal Pain Dietary Supplement: Probiotics Dietary Supplement: Placebo Not Applicable

Detailed Description:
Prospective randomized double-blind placebo-controlled trial.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 101 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Effect of Probiotics in Childhood Abdominal Pain
Study Start Date : March 2011
Actual Primary Completion Date : October 2013
Actual Study Completion Date : October 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Abdominal Pain

Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. Frequency and intensity of abdominal pain [ Time Frame: Eight weeks ]
    Number of pain episodes and pain intensity based on a visual scale


Secondary Outcome Measures :
  1. School absenteeism [ Time Frame: Eight weeks ]
    Number of patients with school absenteeism

  2. Other gastrointestinal symptoms [ Time Frame: Eight weeks ]
    Any gastrointestinal symptom such as nausea, vomiting, diarrhea, bloating

  3. Adverse effects related to treatment [ Time Frame: Eight weeks ]
    Any adverse effects related to the probiotic supplementation


Eligibility Criteria
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Ages Eligible for Study:   6 Years to 15 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Healthy children

Exclusion Criteria:

  • Any chronic or organic illness
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01180556


Locations
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Israel
Soroka Medical Center
Beer-Sheva, Israel, 84101
Sponsors and Collaborators
Soroka University Medical Center
Investigators
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Principal Investigator: Zvi Weizman, MD Soroka University Medical Center
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Soroka University Medical Center
ClinicalTrials.gov Identifier: NCT01180556    
Other Study ID Numbers: Sor493009ctil
4930 ( Other Identifier: SMC )
First Posted: August 12, 2010    Key Record Dates
Last Update Posted: March 29, 2016
Last Verified: March 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Soroka University Medical Center:
childhood
abdominal pain
probiotics
Additional relevant MeSH terms:
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Abdominal Pain
Pain
Neurologic Manifestations
Signs and Symptoms, Digestive