Determining the effect of gasteroesophageal reflux treatment in improving pulmonary function in patients with Cystic Fibrosis
Design
Clinical trial without control group , without blinding , sample size census report, sampling method available
Settings and conduct
The place of operation is Abouzar Ahvaz hospital without blinding.Cystic Fibrosis patients with gasteroesophageal reflux (detected by questionnaire) are treated with proton pump inhibitors and spirometery before and after treatment of these patients are compared.
Participants/Inclusion and exclusion criteria
The participants in the study include patients with Cystic Fibrosis who refer to CF clinic of Abouzar hopital who are over 6 years old, do not have severe lung disease , adhere to treatements , and are not treated with proton pump inhibitors.
Intervention groups
We give proton pump inhibitor drugs to cystic fibrosis patients with gasteroesophageal reflux
Main outcome variables
Improvement of pulmonary function in Cystic Fibrosis patients with gasteroesophageal treated with proton pump inhibitors drugs.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230312057688N1
Registration date:2023-05-01, 1402/02/11
Registration timing:registered_while_recruiting
Last update:2023-05-01, 1402/02/11
Update count:0
Registration date
2023-05-01, 1402/02/11
Registrant information
Name
Elham Pour azar
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 918 356 7481
Email address
pourazar-e@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-04-19, 1402/01/30
Expected recruitment end date
2023-06-20, 1402/03/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
evaluation of the effect of gasteroesophageal reflux treatment on improving pulmonary function in patients with cystic fibrosis
Public title
effect of gasteroesophageal reflux treatment in cystic fibrosis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Cystic fibrosis patients over 6 years old
Not having advanced respiratory disease
Exclusion criteria:
patients treated with proton pump inhibitors
patients with severe pulmonary disease
non adherence to pulmonary treatments
Age
From 6 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
20
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee in Golestan Hospital Research
Street address
Golestan Hospital, Golestan Ave.
City
Ahvaz
Province
Khouzestan
Postal code
6135733118
Approval date
2023-01-10, 1401/10/20
Ethics committee reference number
IR.AJUMS.HGOLESTAN.REC.1401.163
Health conditions studied
1
Description of health condition studied
Cystic Fibrosis
ICD-10 code
E84
ICD-10 code description
Cystic fibrosis
Primary outcomes
1
Description
Forced vital capacity
Timepoint
At the begining of the study and 2 months after the intervention
Method of measurement
spirometery
2
Description
Forced effective volume 1 second
Timepoint
At the begining of the study and 2 months after the intervention
Method of measurement
spirometery
3
Description
Forced Effective Volume 25-75
Timepoint
At the begining of the study and 2 months after the intervention
Method of measurement
spirometery
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group:cystic fibrosis patients with gasteroesophageal reflux are treated with proton pomp inhibitors and spirometery is compared before and after the intervention
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Abouzar Hospital
Full name of responsible person
Elham Pourazar
Street address
Abouzar hospital، Tohid Ave. ، Pasdaran Blvd.
City
Ahvaz
Province
Khouzestan
Postal code
6163614175
Phone
+98 61 3444 3052
Email
pourazar-e@ajums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Mehrnoosh Zakerkish
Street address
Golestan Blvd.،Ahvaz Jundishapour University Medical Science
City
Ahvaz
Province
Khouzestan
Postal code
6135733118
Phone
+98 61 3336 2414
Email
itc@ajums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahvaz 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
Ahvaz University of Medical Sciences
Full name of responsible person
Elham pourazar
Position
fellow
Latest degree
Specialist
Other areas of specialty/work
Pediatrics
Street address
Abouzar hospital، Tohid Ave. ، Pasdaran Blvd.
City
Ahvaz
Province
Khouzestan
Postal code
6163614175
Phone
0098 61
Email
pourazar-e@ajums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Mitra Ahmadi
Position
assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
Pediatrics
Street address
Abouzar hospital، Tohid Ave. ، Pasdaran Blvd.
City
Ahvaz
Province
Khouzestan
Postal code
6163614175
Phone
+98 61 3444 3055
Email
ahmadi_mi@ajums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Elham Pourazar
Position
Fellow
Latest degree
Specialist
Other areas of specialty/work
Pediatrics
Street address
Abouzar hospital، Tohid Ave. ، Pasdaran Blvd.
City
Ahvaz
Province
Khouzestan
Postal code
6163614175
Phone
+98 61 3444 3052
Email
pourazar-e@ajums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
All data can be shared after de-identifying individuals.
When the data will become available and for how long
Access starts one year after results are published
To whom data/document is available
The data will be available only to researchers working in academic and scientific institutions.
Under which criteria data/document could be used
The request to use the data should be sent to the administrator's email , and if approved , the data will be sent.
From where data/document is obtainable
The request to use the data should be sent to the administrator's email , and if approved , the data will be sent.
Dr. Mitra Amadi
ahmadi_mi@ajums.ac.ir
00989124957050
What processes are involved for a request to access data/document
The request to use the data should be sent to the administrator's email , and if approved , the data will be sent.
Dr. Mitra Amadi
ahmadi_mi@ajums.ac.ir
00989124957050