Assesment the effect of synbiotic in the treatment of functional abdominal pain in children compared to placebo.
Design
A double blind clinical trial with an intervention group and a control group with 68 samples, randomized.
Settings and conduct
This is a double-blind clinical trial. In this study, 64 children aged 5-14 years with functional abdominal pain (FAP) referring to Amirkola Children's Hospital randomly will be divided into two groups of case and control. The case group will receive synbiotic and the control group will receive placebo.
Participants/Inclusion and exclusion criteria
Inclusion criteria: FAP Detection based on Rome III criteria.
Exclusion criteria:Immune deficiency; consumption of probiotics or prebiotics within 7 days prior to participating in the study; no antibiotic use during a recent month; chronic underlying disease, and ...
Intervention groups
Intervention group: Daily, 2 Sinobiotic sachets are consumed every 12 hours soluble in water or juice for one month.
Control group:Daily, 2 Placebo are consumed every 12 hours soluble in water or juice for one month.
Main outcome variables
Frequency of pain
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190304042914N1
Registration date:2019-05-25, 1398/03/04
Registration timing:registered_while_recruiting
Last update:2019-05-25, 1398/03/04
Update count:0
Registration date
2019-05-25, 1398/03/04
Registrant information
Name
Azadeh Gholizadeh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 11 3234 6963
Email address
gholizadeh.a.84@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-02-19, 1397/11/30
Expected recruitment end date
2019-08-21, 1398/05/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Assesment the effect of synbiotic in the treatment of functional abdominal pain in children
Public title
Assessment the effect of a drug in the treatment of abdominal pain in children
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
FAP diagnosis based on Rome III criteria
Exclusion criteria:
Immunodeficiency
Consumption of probiotics or prebiotics within 7 days before participating in the study
Chronic underlying disease
Malignancy
The presence of red flags includes a pain that awakens the baby
Continuous pain of RUQ or RLQ
Vomiting (biliary, frequent, periodic, or disturbing for the physician)
Fever without cause
Urogenital Symptoms
Dysphagia
Severe chronic diarrhea or Nocturnal diarrhea
Gastrointestinal bleeding
Unwanted weight loss
Downtrend in the growth curve
Delayed puberty
Family history of IBD
Celiac and PUD
Localized tenderness in RUQ or RLQ
Localized mass
Splenomegaly
Jaundice
CVA tenderness
Arthritis
Vertebral tenderness
Disease in the perianal area
Abnormal or unreasonable findings in the examination
Hematochezia
Anemia
Hepatomegaly
Antibiotic use in the last month
Age
From 5 years old to 14 years old
Gender
Both
Phase
2
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
64
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization is done using a computer and a random number system. Patients are divided into two groups A and B and drugs are coded.
Blinding (investigator's opinion)
Double blinded
Blinding description
In this double blind study, both participants and searcher are unaware of the allocation of study groups to the two groups that receive the drug and the group B receiving the placebo.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Babol University of Medical Sciences
Street address
Ganjafroz Street
City
Babol
Province
Mazandaran
Postal code
4717647745
Approval date
2019-02-19, 1397/11/30
Ethics committee reference number
IR.MUBABOL.HRI.REC.1397.270
Health conditions studied
1
Description of health condition studied
Functional abdominal pain
ICD-10 code
R10.4
ICD-10 code description
Other and unspecified abdominal pain
Primary outcomes
1
Description
Frequency of pain
Timepoint
At the beginning of the study and one month after the start of treatment.
Method of measurement
check list
Secondary outcomes
1
Description
Number of absentee days from school
Timepoint
At the beginning of the study and one month after the start of treatment
Method of measurement
Check list
2
Description
Pain intensity
Timepoint
At the beginning of the study and one month after the start of treatment
Method of measurement
Face scaling
Intervention groups
1
Description
Intervention group: Daily, 2 Sinobiotic sachets are consumed every 12 hours soluble in water or juice for one month.
Category
Treatment - Drugs
2
Description
Control group:Daily, 2 Placebo are consumed every 12 hours soluble in water or juice for one month.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Amirkola Children’s Hospital
Full name of responsible person
Azadeh Gholizadeh
Street address
No 19, Amirkola Children’s Hospital
City
Babol
Province
Mazandaran
Postal code
4731741151
Phone
+98 11 3235 4951
Fax
+98 11 3234 0656
Email
gholizadeh.a.84@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Dr Reza Ghadimi
Street address
Vice- Chancellor for Research Technology Affairs, Babol University of Medical Sciences, Ganjafroz Street
City
Babol
Province
Mazandaran
Postal code
4717647745
Phone
+98 11 3219 9591
Fax
+98 11 3219 4727
Email
info@mubabol.ac.ir
Web page address
http://research.mubabol.ac.ir/
Grant name
-
Grant code / Reference number
-
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Babol 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
Babol University of Medical Sciences
Full name of responsible person
Azadeh gholizadeh
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Pediatrics
Street address
No 19, Amirkola Children’s Hospital
City
Babol
Province
Mazandaran
Postal code
4731741151
Phone
+98 11 3235 4951
Fax
+98 11 3234 0656
Email
gholizadeh.a.84@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Azadeh Gholizadeh
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Pediatrics
Street address
No 19, Amirkola Children’s Hospital
City
Babol
Province
Mazandaran
Postal code
4731741151
Phone
+98 11 3235 4951
Fax
+98 11 3234 0656
Email
gholizadeh.a.84@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Azadeh Gholizadeh
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Pediatrics
Street address
No 19, Amirkola Children’s Hospital
City
Babol
Province
Mazandaran
Postal code
4731741151
Phone
+98 11 3234 6963
Fax
+98 11 3234 6963
Email
gholizadeh.a.84@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available