Evaluation of the effects of lyophilized Saccharomyces Boulardii capsules on quality of life and clinical outcomes in children with inflammatory bowel disease (IBD)
In this study, 60 children with Inflammatory Bowel Disease hospitalized in Mofid children hospital will enroll in the study after getting informed consent from parents. The patients will be divided into two groups of intervention and control, and a drug package with a unique code will be delivered to them. The patient, the caregiver and the investigator will be blind to the package content.
Participants/Inclusion and exclusion criteria
inclusion criteria:
children who aged between 1 to 16
children with IBD
exclusion criteria:
primary or secondary immunodeficiency
Intervention groups
one group received 2 capsules for two months that each capsule is consist of 250 milligrams Saccharomyces Boulardii
The other group received 2 placebo capsule for two months
Main outcome variables
Pain; quality of life
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20120415009475N5
Registration date:2018-10-10, 1397/07/18
Registration timing:retrospective
Last update:2018-10-10, 1397/07/18
Update count:0
Registration date
2018-10-10, 1397/07/18
Registrant information
Name
Bahador Mirrahimi
Name of organization / entity
Shahid Beheshti University of Medical Sciences, Faculty of Pharmacy
Country
Iran (Islamic Republic of)
Phone
+98 21 8820 0118
Email address
mirrahimi@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-03-06, 1396/12/15
Expected recruitment end date
2018-09-23, 1397/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effects of lyophilized Saccharomyces Boulardii capsules on quality of life and clinical outcomes in children with inflammatory bowel disease (IBD)
Public title
Effects of Saccharomyces Boulardii capsules in pediatric Inflammatory bowel disease
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Children the age of 1-16
Children with IBD
Exclusion criteria:
primary and secondary immunodeficiency
allergy to drug
Age
From 1 year old to 16 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Data and Safety Monitoring Board
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
the randomization has been performed using the permuted block randomization table.
Blinding (investigator's opinion)
Triple blinded
Blinding description
The drug and placebo will be in coded same packages; a designated person will provide the codes from permuted block randomization via phone. The same person will group the data at the end of the trial, and the expert will perform statistical analysis and after results, the pocket that is with the placebo provider would be opened, and the data will be decrypted. The data regarding harm and benefits of treatment will be provided to the patient and caregiver.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shahid Beheshti University of Medical Sciences
Street address
Sharyati Ave.,Mofid hospital
City
Tehran
Province
Tehran
Postal code
1546815514
Approval date
2017-12-30, 1396/10/09
Ethics committee reference number
IR.SBMU.PHNM.1396.888
Health conditions studied
1
Description of health condition studied
Inflammatory bowel disease
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Pain
Timepoint
In this study we checked the effects of Saccharomyces Boulardii capsules in the beginning of the study and two months later
Method of measurement
by interview and completing Visual Analogue Scale by patients
2
Description
Quality of life
Timepoint
In this study we checked the effects of Saccharomyces Boulardii capsules in the beginning of the study and two months later
Method of measurement
By interview and completing IMPACT III questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: The patients receive two capsules for two months that each capsule contain 250 milligram Saccharomyces Boulardii
Category
Treatment - Drugs
2
Description
Control group: this group receive two placebo capsule for two months.