Protocol summary

Summary
This study investigated the effect of probiotics on quality of life, growth indicators and also pulmonary exacerbations in children with Cystic Fibrosis. In this study, 37 patients (2-12 years old) were randomly divided into two groups. The children who did not have the ability of probiotic consumption to cause severe disease or their parents were dissatisfied, were excluded from the study. 20 patients of case group took probiotics for 1 month and 17 patients of control group only took routine treatments. Growth indicators such as weight, height, head circumference (HC) and arm circumference (AC) and pulmonary exacerbations obtained at 1st and 3rd month after giving probiotics administration. Quality of life was also determined with using specific questionnaire PedsQL 4.0 at beginning, 3rd and 6th month and was compared with the control group as well as corresponding months of last year.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201205219823N1
Registration date: 2012-07-25, 1391/05/04
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2012-07-25, 1391/05/04
Registrant information
Name
Rasool Asoodeh Forootagheh
Name of organization / entity
Mashhad University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 985118544643
Email address
asoudehr901@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor of Research, Mashhad University of Medical Sciences
Expected recruitment start date
2010-06-23, 1389/04/02
Expected recruitment end date
2011-12-23, 1390/10/02
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of probiotic effect on growth indicators and quality of life in children with Cystic Fibrosis
Public title
Probiotic effect on growth and quality of life in children with Cystic Fibrosis
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: Ages 2 to 12 years old; Cystic Fibrosis disease confirmed by sweat testing, clinical symptoms and common mutations. Exclusion criteria: Patient intolerance to the medication; A lack of parental consent; Inability of probiotic consumption because of severe disease.
Age
From 2 years old to 12 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size: 37
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Mashhad University of Medical Sciences
Street address
Ghorayshi Building, Daneshgah St.
City
Mashhad
Postal code
Approval date
2011-12-23, 1390/10/02
Ethics committee reference number
88660

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
Number of pulmonary exacerbations
Timepoint
One month after the intervention, three months after the intervention
Method of measurement
Review records of patients

2

Description
Quality of Life
Timepoint
Before the intervention, three months after the intervention, six months after intervention
Method of measurement
PedsQL 4.0 questionnaire

3

Description
Height
Timepoint
Before the intervention, one month after the intervention, three months after the intervention
Method of measurement
Wall of examination room

4

Description
Weight
Timepoint
Before the intervention, one month after the intervention, three months after the intervention
Method of measurement
Standard scale

5

Description
Head Circumference
Timepoint
Before the intervention, one month after the intervention, three months after the intervention
Method of measurement
Meter

6

Description
Arm Circumference
Timepoint
Before the intervention, one month after the intervention, three months after the intervention
Method of measurement
Meter

Secondary outcomes

empty

Intervention groups

1

Description
The intervention group: Protexin, 2 Capsules, daily, 1 Month
Category
Treatment - Drugs

2

Description
The control group: No action
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Dr. Sheykh Hospital
Full name of responsible person
Dr. Elaheh Abbasnezhad Mohamadabad
Street address
Dr. Sheykh Hospital, Taheri St., Tohid Sq.
City
Mashhad

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice Chancellor of Research, Mashhad University of Medical Sciences
Full name of responsible person
Dr. Mohammad Ramezani, Research Assistant
Street address
Vice Chancellor of Research, Ghorayshi Building, Daneshgah St.
City
Mashhad
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor of Research, Mashhad 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
Ghaem Hospital
Full name of responsible person
Dr. Hamidreza Kianifar
Position
Assistant Professor of Mashhad University of Medical Sciences ; Pediatric gastroenterologist
Other areas of specialty/work
Street address
Department of Pediatrics, Ghaem Hospital, Beginning of Ahmadabad Blvd.
City
Mashhad
Postal code
Phone
+98 51 1840 0001
Fax
Email
kianifarhr@mums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Ghaem Hospital
Full name of responsible person
Dr. Hamidreza Kianifar
Position
Pediatric gastroenterologist
Other areas of specialty/work
Street address
Department of Pediatrics, Ghaem Hospital, Beginning of Ahmadabad Blvd.
City
Mashhad
Postal code
Phone
+98 51 1840 0001
Fax
Email
kianifarhr@mums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Ghaem Hospital
Full name of responsible person
Dr. Hamidreza Kianifar
Position
Pediatric gastroenterologist
Other areas of specialty/work
Street address
Department of Pediatrics, Ghaem Hospital, Beginning of Ahmadabad Blvd.
City
Mashhad
Postal code
Phone
+98 51 1840 0001
Fax
Email
kianifarhr@mums.ac.ir
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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