The aim of study is evaluation of probiotic effect on gut inflammation in CF patients on the basis of the level of stool calporotecitn.
The CF patients with age over 4 years old who are followed in GI clinic of children medical center and have inclusion criteria (age over 4 years old and pancrease insufficiency) are evaluated, the questionnaire are filled, the stool samples are taker and they are maintained in -80 c for redetection of calportiectin level by Elisa test.
25 patients are considered case, and 25, in control group. The case patient are given probiotic powder 1 suchet/ day for 4 weeks and the control patients are given placebo (maltodextrine) 1 suchet / day for 4 weeks. After 4 weeks the new stool samples are examined again for the level of calportectin due Elisa test.
The level of <50 μ gr/ gr stool is considered normal and the level of > 100 μ gr/ gr stool is considered due to gut inflammation. The border line level needs further evaluation.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201201258778N3
Registration date:2012-03-12, 1390/12/22
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2012-03-12, 1390/12/22
Registrant information
Name
Farzaneh Motamed
Name of organization / entity
Children Medica lCenter
Country
Iran (Islamic Republic of)
Phone
+98 21 6692 4545
Email address
fmotamed@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
drug and placebo send by producer company without any mony and price for doing test pay by tehran medical univercity
Expected recruitment start date
2012-01-30, 1390/11/10
Expected recruitment end date
2012-04-29, 1391/02/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of probiotics on intestinal inflammation in CF patients whit age morthan 4 years base on fecal calportectine a double blind clinical trial
Public title
Effect of probiotics on intestinal inflammation in CF patients whit age morthan 4 years
Purpose
Treatment
Inclusion/Exclusion criteria
inclusion criteria; cf patient ; age morethan 4years ; pancrease insuficient ; un use NSAID for 2 weaks ago
exclusion criteria; age before 4 years ; pancrease sufficient ; use NSAID during 2 weaks ago
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:
25
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
tehran univercity of medical sience
Street address
boulvar keshavarze ghodse street
City
tehran
Postal code
Approval date
2020-12-18, 1399/09/28
Ethics committee reference number
90/130/1991
Health conditions studied
1
Description of health condition studied
cystic fibrosis
ICD-10 code
E 84.1
ICD-10 code description
cystic fibrosis with intestinal manifestation
Primary outcomes
1
Description
fecal calprotectin
Timepoint
befor of the study and one mounth later
Method of measurement
measurement of fecal calprotectin
Secondary outcomes
empty
Intervention groups
1
Description
protexine 2 sachet per day which can mixed with yoghurt
Category
Treatment - Drugs
2
Description
maltodexterin 2 sachet per day which can mixed in yoghurt
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Children Medical Center
Full name of responsible person
Dr Azizollah Yousefi
Street address
Children Medical Center 62 Gharib st 14194 Tehran Iran
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Ms Alamdar
Street address
Tehran University of Medical Sciences Qods St Bolouvard keshavarz Tehran Iran
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran University of Medical Sciences
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
Children Medical Center
Full name of responsible person
Dr Azizollah Yousefi
Position
Pediatric Gasteroeterology Flow
Other areas of specialty/work
Street address
Children Medical Center 62 Gharib St 14194 Tehran Iran
City
Tehran
Postal code
Phone
+98 21 6694 8443
Fax
Email
Dra_yusefi@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Children Medical Center
Full name of responsible person
Dr Farzaneh Motamed
Position
Pediatric Gasteroentrologist Associated Professor
Other areas of specialty/work
Street address
Children Medical Center 62 Gharib St 14194 Tehran Iran
City
Tehran
Postal code
Phone
+98 21 6694 8443
Fax
Email
fmotamed@sina.tums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Children Medical Center
Full name of responsible person
Dr Azizollah yousefi
Position
Pediateric Gasteroentrologist Flow
Other areas of specialty/work
Street address
Children Medical Center 62 Gharib St 14194 Tehran Iran
City
Tehran
Postal code
Phone
00
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)