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Effect of synbiotic supplementation in comparison with placebo on anthropometric indeices, quality of life and clinical outcome in children with cystic fibrosis.

Protocol summary

Summary
The aim of the present study is determining the effect of Synbiotic supplementation on anthropocentric indices, quality of life, frequency of pulmonary exacerbation, frequency of hospitalization and antibiotic therapy in children with cystic fibrosis. This study is a clinical trial. The study population will consist of 40 children with cystic fibrosis. The inclusion are children with cystic fibrosis aged between 5-12 years. The exclusion criteria are having other disease including diabetes, cirrhosis, hypo-Albominemia, ventilator dependent respiratory failure. After measuring weight and height, BMI will be calculated and after then, the amount of antibiotic consumption, frequency of pulmonary exacerbation, frequency of hospitalization are recorded and gastrointestinal discomfort (diarrhea) and quality of life of children are evaluated and after getting the informed consent, the children will randomly assign to intervention or placebo group according to their age and sex. The patients in intervention group will receive 2 synbiotic capsules daily 2 hours after antibiotic treatment and the patients in placebo group will receive 2 placebo daily for 6 month. The primary outcomes are monthly measuring of weight, height, BMI, frequency of hospitalization and pulmonary exacerbation, bimonthly evaluation of oral or IV antibiotic receiving for 6 month, monthly assessment of diarrhea frequency and quality of life using pedsQL 4.0. For total antioxidant assessment, RANDOX kit will be used and for MDA assessment spectrophotometry method will be used.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2017011732004N1
Registration date: 2017-02-14, 1395/11/26
Registration timing: prospective

Last update:
Update count: 0
Registration date
2017-02-14, 1395/11/26
Registrant information
Name
Zeinab Nikniaz
Name of organization / entity
Liver and gastrointestinal disease research center, Tabriz University of medical sciences-Tabriz_Ir
Country
Iran (Islamic Republic of)
Phone
+98 41 3336 7473
Email address
nikniazz@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Pediatrics health research center
Expected recruitment start date
2017-04-04, 1396/01/15
Expected recruitment end date
2019-04-01, 1398/01/12
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of synbiotic supplementation in comparison with placebo on anthropometric indeices, quality of life and clinical outcome in children with cystic fibrosis.
Public title
Effect of synbiotic in cystic fibrosis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: children with cystic fibrosis; aged between 5-12 years exclusion criteria: having other disease including diabetes; cirrhosis; hypo-albominemia; ventilator dependent respiratory failure
Age
From 5 years old to 12 years old
Gender
Male
Phase
1-2
Groups that have been masked
No information
Sample size
Target sample size: 40
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Triple blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

1

Registry name
a
Secondary trial Id
a
Registration date
2017-11-22, 1396/09/01

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Tabriz University of medical sciences
Street address
Daneshgah St. Tabriz University of medical sciences
City
Tabriz
Postal code
Approval date
2016-10-24, 1395/08/03
Ethics committee reference number
IR.TBZMED.REC.1395.919

Health conditions studied

1

Description of health condition studied
Cystic fibrosis
ICD-10 code
E84
ICD-10 code description
E84.0 Cystic fibrosis with pulmonary manifestations

Primary outcomes

1

Description
Anthropocentric measures
Timepoint
before supplementation and every month after supplementation for 6 month
Method of measurement
scale and stadiomete

2

Description
Diarehea
Timepoint
Before supplementation and every month after supplementation for 6 month
Method of measurement
Questionnaire

3

Description
Quality of life
Timepoint
before supplementation and every month after supplementation for 6 month
Method of measurement
Questionnaire

4

Description
antibiotic treatment (oral and IV therapy)
Timepoint
before supplementation and 2, 4 and 6 month after supplemenattion
Method of measurement
Questionnaire

5

Description
hospitalization
Timepoint
before supplementation and every month after supplementation for 6 month
Method of measurement
Questionnaire

Secondary outcomes

1

Description
Serum total antioxidant
Timepoint
before and after six month of supplementation
Method of measurement
commercial kit

Intervention groups

1

Description
intervention: 2 synbiotic capsule per day fami lact capsuls from Zist Takhmir factory capsuls include: 10 9 bacteria namely Lactobacilus casei, Lactobacilus Ramnosis, Lactobacilus bolgaricus, streptococus thermophillus, bifidobacterium Langom and froctooligosacharide (FOS) prebiotic
Category
Treatment - Drugs

2

Description
2 placebo capsules/day including corn starch
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Pediatric educational and treatment center
Full name of responsible person
Dr Nemat Bilan
Street address
Sheshgelan, Tabriz pediatrics hospital
City
Tabriz

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Pediatric health research center
Full name of responsible person
Dr Mohammad barzgar
Street address
Sheshgelan, Tabriz pediatric hopital
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Pediatric health research center
Proportion provided by this source
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

2

Sponsor
Name of organization / entity
Vice Chancellor for research of Tabriz University of Medical Sciences
Full name of responsible person
Dr Rashidi
Street address
Tabriz University of medical sciences, Daneshgah St. Golgasht Ave. Tabriz-Iran
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for research of Tabriz University of Medical Sciences
Proportion provided by this source
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
Liver and gastrointestinal disease research center
Full name of responsible person
Dr zeinab Niknaiz
Position
Assistant Proffessor
Other areas of specialty/work
Street address
Imam Reza hospital, Tabriz-Iran
City
Tabriz
Postal code
Phone
+98 41133351688
Fax
Email
nikniazz@tbzmed.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tabriz Children Hospital
Full name of responsible person
Dr Nemat Bilan
Position
Proffessor
Other areas of specialty/work
Street address
Sheshgelan, Tabriz children hospital
City
Tabriz
Postal code
Phone
+98 41 3526 2250
Fax
Email
bilan@tbzmed.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
medicineschool, Tabriz University of medical sciences
Full name of responsible person
Dr Marefat
Position
medicine student
Other areas of specialty/work
Street address
Tabriz University of medical sciences, Medicine faculty, Daneshgha St, Tabriz_Iran
City
Tabriz
Postal code
Phone
+98 41 3335 1688
Fax
Email
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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