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Effect of Probiotics in Childhood Abdominal Pain

Primary Purpose

Abdominal Pain

Status
Completed
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Probiotics
Placebo
Sponsored by
Soroka University Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Abdominal Pain focused on measuring childhood, abdominal pain, probiotics

Eligibility Criteria

6 Years - 15 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Healthy children

Exclusion Criteria:

  • Any chronic or organic illness

Sites / Locations

  • Soroka Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Probiotics supplementation

Placebo

Arm Description

Supplementation by probiotics for 4 weeks

Supplementation of placebo for 4 weeks

Outcomes

Primary Outcome Measures

Frequency and intensity of abdominal pain
Number of pain episodes and pain intensity based on a visual scale

Secondary Outcome Measures

School absenteeism
Number of patients with school absenteeism
Other gastrointestinal symptoms
Any gastrointestinal symptom such as nausea, vomiting, diarrhea, bloating
Adverse effects related to treatment
Any adverse effects related to the probiotic supplementation

Full Information

First Posted
August 9, 2010
Last Updated
March 27, 2016
Sponsor
Soroka University Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT01180556
Brief Title
Effect of Probiotics in Childhood Abdominal Pain
Official Title
The Effect of Probiotics in Childhood Abdominal Pain
Study Type
Interventional

2. Study Status

Record Verification Date
March 2016
Overall Recruitment Status
Completed
Study Start Date
March 2011 (undefined)
Primary Completion Date
October 2013 (Actual)
Study Completion Date
October 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Soroka University Medical Center

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Abdominal Pain
Keywords
childhood, abdominal pain, probiotics

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
101 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Probiotics supplementation
Arm Type
Experimental
Arm Description
Supplementation by probiotics for 4 weeks
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Supplementation of placebo for 4 weeks
Intervention Type
Dietary Supplement
Intervention Name(s)
Probiotics
Other Intervention Name(s)
probiotic agent, L. reuteri
Intervention Description
Daily oral supplementation for four weeks
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Other Intervention Name(s)
placebo tablets
Intervention Description
Placebo administration
Primary Outcome Measure Information:
Title
Frequency and intensity of abdominal pain
Description
Number of pain episodes and pain intensity based on a visual scale
Time Frame
Eight weeks
Secondary Outcome Measure Information:
Title
School absenteeism
Description
Number of patients with school absenteeism
Time Frame
Eight weeks
Title
Other gastrointestinal symptoms
Description
Any gastrointestinal symptom such as nausea, vomiting, diarrhea, bloating
Time Frame
Eight weeks
Title
Adverse effects related to treatment
Description
Any adverse effects related to the probiotic supplementation
Time Frame
Eight weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Healthy children Exclusion Criteria: Any chronic or organic illness
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zvi Weizman, MD
Organizational Affiliation
Soroka University Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Soroka Medical Center
City
Beer-Sheva
ZIP/Postal Code
84101
Country
Israel

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
27156182
Citation
Weizman Z, Abu-Abed J, Binsztok M. Lactobacillus reuteri DSM 17938 for the Management of Functional Abdominal Pain in Childhood: A Randomized, Double-Blind, Placebo-Controlled Trial. J Pediatr. 2016 Jul;174:160-164.e1. doi: 10.1016/j.jpeds.2016.04.003. Epub 2016 May 4.
Results Reference
derived

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Effect of Probiotics in Childhood Abdominal Pain

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