Nonfunctional chronic abdominal pain is common disorder in child. This is a benign disease, But this is a cause of Anxiety. different mechanism is expressed. Change in bacterial environment in GI tract can lead nonfunctional abdominal pain in child. Probiotics can reduce bacterial overgrowth and reduce Mucosal Inflammation. Several studies showed effect of probiotics in nonfunctional abdominal pain in children. Aim of our study is probiotic effects on nonfunctional abdominal pain in children.
Studied 52 children in a randomized, double blind and controlled study that will be selected from the outpatients of Doctor Sheikh Children's Hospital Medical Center. All children are evaluated by a pediatric gastroenterologists and diagnosed chronic abdominal pain in children. Reject organic diseases causing abdominal pain for them.
All children from 4 to 18 years with gastrointestinal functional disorder consistent with ROME III criteria are entered the test. Children under the age of 4 or over 18, whom are received the drug for the treatment of chronic pain (such as drug treatment, such as herbal medicines or probiotics), or receiving drugs that are known as cause abdominal pain, are excluded from the study. By randomization is determined that which patients receive probiotics or placebo. Probiotic and placebo include at least Concentration 10^8 bacill or placebo will be provided. Placebo and probiotic in shape, size, color and taste will be similar. The probiotic and placebo will be administered 2 times a day for a period of 4 weeks.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201205219825N1
Registration date:2012-07-05, 1391/04/15
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2012-07-05, 1391/04/15
Registrant information
Name
Elham Sharbaf Eidgahi
Name of organization / entity
Mashhad University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 51 1854 4643
Email address
sharbafe901@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Mashhad university of medical sciencese
Expected recruitment start date
2012-02-29, 1390/12/10
Expected recruitment end date
2012-10-21, 1391/07/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of probiotics effect on non-organic chronic Abdominal pain in children
Public title
Evaluation of probiotics effect on non-organic chronic Abdominal pain in children
Purpose
Treatment
Inclusion/Exclusion criteria
All children from 4 to 18 years with gastrointestinal functional disorder consistent with ROME III criteria are entered the test. Children under the age of 4 or over 18, whom are received the drug for the treatment of chronic pain (such as drug treatment, such as herbal medicines or probiotics), or receiving drugs that are known as cause abdominal pain, are excluded from the study.
Age
From 4 years old to 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
52
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Qureshi Building
Street address
Daneshgah Avenue
City
Mashhad
Postal code
Approval date
2012-02-18, 1390/11/29
Ethics committee reference number
89840
Health conditions studied
1
Description of health condition studied
Non-organic chronic abdominal pain in children
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Abdominal pain improvement
Timepoint
Every week to 4 weeks
Method of measurement
By patients and parents - Questionnare forms
Secondary outcomes
1
Description
Daily activity improvement
Timepoint
Every week to 4 weeks
Method of measurement
By patients and parents - Questionnare forms
2
Description
Change of defication
Timepoint
Every week to 4 weeks
Method of measurement
By patients and parents - Questionnare forms
3
Description
Change in appetite
Timepoint
Every week to 4 weeks
Method of measurement
By patients and parents - Questionnare forms
Intervention groups
1
Description
probiotic pills - for 4weeks- 1 tablet daily - Concentration 10^7 to 10^9 bacill
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Dr. Sheikh Hospital
Full name of responsible person
Street address
City
Mashhad
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad university of medical sciencese
Full name of responsible person
Dr Mohammad Ramezani
Street address
Daneshgah Avenue, Qureshi Building
City
Mashhad
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad university of medical sciencese
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Seyed Vahid Ghasemi
Position
Pediatrics
Other areas of specialty/work
Street address
Imam Reza Hospital
City
Mashhad
Postal code
Phone
+98 915 311 8045
Fax
Email
ghasemiv891@mums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Hamid Reza Kianifar
Position
Assistant Professor
Other areas of specialty/work
Street address
Ahmad abad Avenue_ghaem hospital
City
Mashhad
Postal code
Phone
+98 51 1841 7451
Fax
Email
Kianifarh@mums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Seyed Vahid Ghasemi
Position
Pediatrics
Other areas of specialty/work
Street address
Imam Reza Hospital
City
Mashhad
Postal code
Phone
00
Fax
Email
ghasemiv891@mums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)