The effect of dairy-free diet on irritable bowel syndrome in children over 5 years
Design
Clinical trial with case and control group, single blind, non-random
Settings and conduct
In order to blind the study, the questionnaire is divided into two groups and the patient is asked to select one group and thus is assigned to one of the case or control groups.
The Control group under normal diet and the case groups were exposed to a dairy-free diet for two weeks, including cheese, butter, milk, cream, and other dairy foods, which are one of the triggers for IBS.
Finally, the two groups are compared in terms of symptoms.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
1. Informed consent from parents
2.Children over 5 years
3.Have no underlying disease
Exclusion criteria:
1.Children under 5 years
2.Have underlying disease
3.Have a special diet
Intervention groups
Intervention group: Patients with IBS who are on a dairy-free diet for two weeks
Control group: Patients with IBS undergo a regular diet (containing dairy products) for two weeks
Main outcome variables
Significant differences may indicate role of dairy-free diet in symptoms of patients with irritable bowel syndrome
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190806044462N1
Registration date:2019-09-14, 1398/06/23
Registration timing:retrospective
Last update:2019-09-14, 1398/06/23
Update count:0
Registration date
2019-09-14, 1398/06/23
Registrant information
Name
ali tabrizi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 86 3222 0099
Email address
a.tabrizi@arakmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-08-06, 1398/05/15
Expected recruitment end date
2019-09-06, 1398/06/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Study of the effect of dairy free diet on irritable bowel syndrome in over 5 year old children
Public title
Exploring the effect of dairy free diet on irritable bowel syndrome in over 5 year old children
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
1.Informed consent
2.Children above 5 years
Have no underlying disease
Exclusion criteria:
Have a special diet
Children under 5 years
Have underlying disease
Age
From 5 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
152
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Other
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of arak University of Medical Sciences
Street address
khoram street
City
arak
Province
Markazi
Postal code
0287025012
Approval date
2019-07-10, 1398/04/19
Ethics committee reference number
IR.ARAKMU.REC.1398.104
Health conditions studied
1
Description of health condition studied
irritable bowel syndrome
ICD-10 code
K58.0
ICD-10 code description
Irritable bowel syndrome with diarrhea
Primary outcomes
1
Description
Clinical symptoms of irritable bowel syndrome
Timepoint
Before and 2 weeks after treatment
Method of measurement
Interview with the patient
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Patients with IBS who are on a dairy-free diet for two weeks
Category
Lifestyle
2
Description
Control group: Patients with IBS undergo a regular diet (containing dairy products) for two weeks
Category
Lifestyle
Recruitment centers
1
Recruitment center
Name of recruitment center
Amir kabir hospital
Full name of responsible person
dr noushin sajadi
Street address
khoram street
City
arak
Province
Markazi
Postal code
332200998692
Phone
+98 86 3322 0099
Email
a.tabrizi@arakmu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
dr noushin sajadi
Street address
khoram street
City
arak
Province
Markazi
Postal code
3253182380
Phone
+98 86 3322 0099
Email
a.tabrizi@arakmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
arak university of medical sciense
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
Arak University of Medical Sciences
Full name of responsible person
dr noushinj sajdadi
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Pediatrics
Street address
khoram street
City
arak
Province
Markazi
Postal code
32850157106
Phone
+98 86 3222 0099
Email
a.tabrizi@arakmu.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
dr noushin sajadi
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Pediatrics
Street address
khoram street
City
arak
Province
Markazi
Postal code
200285266205
Phone
+98 86 3222 0099
Email
a.tabrizi@arakmu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
dr noushin sajadi
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Pediatrics
Street address
khoram street
City
arak
Province
Markazi
Postal code
24125605286
Phone
+98 86 3222 0099
Email
a.tabrizi@arakmu.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Not applicable
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
All data can be shared
When the data will become available and for how long
starting 6 months after publication
To whom data/document is available
Public access is free
Under which criteria data/document could be used
No limit
From where data/document is obtainable
dr ali tabrizi email: a.tabrizi@arakmu.ac.ir
What processes are involved for a request to access data/document
The data is provided to the applicant within one month