Specific goals
1. Determining the Effectiveness of Saccharomyces Bollardi in the Treatment of Pediatric Abdominal Functional Pain by Age
2- Determining the Effectiveness of Saccharomyces Bollardi in the Treatment of Pediatric Functional Abdominal Pain by Sex
3. Comparison of the efficacy of Saccharomyces Boulardi and placebo in the treatment of pediatric abdominal functional pain according to duration of treatment
Practical purposes:
Providing effective probiotic treatment for pediatric abdominal functional pain
Design
This study is a clinical trial on the statistical population of 104 children with functional abdominal pain between 2 and 4 years old based on Roman Criteria 3 referring to Pediatric Gastroenterology Clinic.
In this study, after obtaining informed consent from enrolled patients
And begin treatment with placebo or Saccharomyces Bullardi (two capsules daily containing 250 mg of Saccharomyces Bullardi).
Patients receive placebo or Saccharomyces Bullardi for three weeks, during which time they complete the OUCHER questionnaire on pain intensity daily.
The amount of pain felt per day and its severity are also recorded.
Settings and conduct
Children referred to the Pediatric Gastroenterology Clinic where parents and physicians are blinded to drug or placebo treatment.
Participants/Inclusion and exclusion criteria
Children with 1-5 years of age with functional abdominal pain are treated on the basis of Roman Criteria 3 referring to the Pediatric Gastrointestinal Clinic. All of these criteria must be present for at least three months and symptoms begin at least six months before diagnosis.
Intervention groups
Intervention group: Children treated with Saccharomyces Bullardi (two capsules daily containing 250 mg)
Control group: children treated with placebo
Main outcome variables
Pain severity based on OUCHER questionnaire
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180822040850N1
Registration date:2019-11-23, 1398/09/02
Registration timing:retrospective
Last update:2019-11-23, 1398/09/02
Update count:0
Registration date
2019-11-23, 1398/09/02
Registrant information
Name
Ali Dehdashtyzadeh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3331 6243
Email address
adehdashtyzade@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-08-27, 1397/06/05
Expected recruitment end date
2018-10-14, 1397/07/22
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison between the efficacy of saccharomyces boulardii and placebo on treatment of pediatric functional abdominal pain
Public title
Effect of saccharomyces boulardii in treatment of pediatric functional abdominal pain
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Children from 5 to 15 years old
Have rome 3 criteria for functional abdominal pain
Participants and parents have informed consent
Paraclinical is normal
Exclusion criteria:
Children who have visceral abdominal pain
Children have abnormal laboratory tests findings
Children have abnormal abnormal abdominopelvic sonography findings
Parents of children have not completed the informed consent form
Age
From 5 years old to 15 years old
Gender
Both
Phase
2-3
Groups that have been masked
Participant
Care provider
Investigator
Sample size
Target sample size:
104
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, randomization of people was done by a statistical software to two blocks of 52 people. Allocation concealment is done by the central service with the code.
Blinding (investigator's opinion)
Double blinded
Blinding description
This is a double-blind study in which participants, clinical caregivers and researchers are blind about groups.Encoded participants are assigned by the Central Service. After completion of the study they will be identified, when the code is opened and assigned to the control or case groups.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Ilam University of Medical Sciences
Imam Khomeini Hospital,Ayatollah Heydari St. Ilam,Iran.
City
Ilam
Province
Ilam
Postal code
6931975397
Phone
+98 84 3333 4500
Email
emamkhominihospital@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ilam University of Medical Sciences
Full name of responsible person
Gholamreza Kalvandi
Street address
Ilam university of medical sciences, Azadi Blvd,Keshvari Sq,Ilam,Iran.
City
Ilam
Province
Ilam
Postal code
٦٩٣١٨٥١١٤٧
Phone
+98 84 3333 4060
Email
info@medilam.ac.ir
Web page address
http://www.medilam.ac.ir/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ilam University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Ilam University of Medical Sciences
Full name of responsible person
Ali Dehdashtizadeh
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Pediatrics
Street address
Ayatollah Heydari St,Ilam.
City
Ilam
Province
Ilam
Postal code
6931975397
Phone
+98 84 3333 4500
Email
adehdashtyzade@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ilam University of Medical Sciences
Full name of responsible person
Ali Dehdashtizadeh
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Pediatrics
Street address
Ayatollah Heydari St,Ilam.
City
Ilam
Province
Ilam
Postal code
6931975397
Phone
+98 84 3333 4500
Email
adehdashtyzade@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Ilam University of Medical Sciences
Full name of responsible person
Ali Dehdashtizadeh
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Pediatrics
Street address
Ayatollah Heydari St, Illam
City
Illam
Province
Ilam
Postal code
6931975397
Phone
+98 84 3333 4500
Email
adehdashtyzade@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
Finally, some of the data on study results and outcomes are generally published in the form of reports and articles.
When the data will become available and for how long
Once the study is completed and the final report is published , with no time limit.
To whom data/document is available
Researchers at academic and scientific institutes and the pharmaceutical industry
Under which criteria data/document could be used
Certain conditions are not considered
From where data/document is obtainable
Correspondence with the author or receipt of the artice
What processes are involved for a request to access data/document
Upon completion of the study and writing of the report, it is possible to receive a printed article or correspondence with the project responsible by email.