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Effect of Probiotics in Childhood Abdominal Pain

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01180556
Recruitment Status : Completed
First Posted : August 12, 2010
Last Update Posted : March 29, 2016
Information provided by (Responsible Party):
Soroka University Medical Center

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.

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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

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

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

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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

Inclusion Criteria:

  • Healthy children

Exclusion Criteria:

  • Any chronic or organic illness

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 identifier (NCT number): NCT01180556

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Soroka Medical Center
Beer-Sheva, Israel, 84101
Sponsors and Collaborators
Soroka University Medical Center
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Principal Investigator: Zvi Weizman, MD Soroka University Medical Center
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Soroka University Medical Center 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:
abdominal pain
Additional relevant MeSH terms:
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Abdominal Pain
Neurologic Manifestations
Signs and Symptoms, Digestive