The aim of this study is evaluation the effect of probiotic consumption on count of albicans candida in chemotherapy patients. In this study, single-blind clinical trial, 50 patients as inclusion criteria (Breast Cancer Patients with Cancer of the colon or candidates for chemotherapy, etc.) and exclusion (pregnant women, smokers, etc.) are selected. Patients are randomly divided into two groups. The intervention group Kafir probiotic yogurt drink and the control group are consumed mineral water. Subjects in both groups at certain hours of the day, hundred cc of it are used. In this study, blood and saliva samples are taken five times. At the turn of chemotherapy, blood and saliva samples will be carried out before receiving chemotherapy drugs. Likewise other samples are taken before the next chemotherapy sessions. The last samples from patients are taken at the end of probiotic administration. At the end of consumption albicans Candida are compared in the two groups. The primary outcome of this study, is saliva count of candida albicans.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201506181760N41
Registration date:2015-07-14, 1394/04/23
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2015-07-14, 1394/04/23
Registrant information
Name
Nargess Gholizadeh Pasha
Name of organization / entity
Fatemehzahra Infertility Reproductive Health Research Center, Babol University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 11 3236 2282
Email address
zahra@mubabol.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research and Technology, Babol University of Medical Sciences
Expected recruitment start date
2015-01-21, 1393/11/01
Expected recruitment end date
2015-07-23, 1394/05/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of effect of consumption kafir probiotic on saliva count of candida albicans in chemotherapy patients
Public title
Evaluation of effect of consumption kafir probiotic on saliva count of candida albicans in chemotherapy patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Breast Cancer Patients with Cancer of the colon or candidate for chemotherapy; Patients aged twenty to sixty years with the same chemotherapy regimen
Exclusion criteria:
Patients with a history of chemotherapy and radiation therapy; Patients with atrophic tongue; Anemia; With mucocutaneous disease; The use of partial or full dentures; With a history of oral diseases; People with underlying medical conditions (eg, diabetes, hypertension, etc.); Pregnant women; Smokers; The use of broad-spectrum antibiotics and anti-fungal drugs
Age
From 20 years old to 60 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
This study is a single-blind clinical trial. How random is simple. Kafir yogurt and mineral water in containers not show the same content container provided by individual coded. The code other than the person is not aware of the contents of the containers coded.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Babol University of Medical sciences
Street address
Babol University of Medical Sciences, Ganjafroz Avenu
City
Babol
Postal code
Approval date
2015-01-10, 1393/10/20
Ethics committee reference number
5032
Health conditions studied
1
Description of health condition studied
Oral candidiasis
ICD-10 code
B37
ICD-10 code description
Candidiasis
Primary outcomes
1
Description
The number of Candida albicans in normal flora
Timepoint
Before receiving chemotherapy treatment and at the end of last sampling of the patients taking probiotics
Method of measurement
Laboratory
Secondary outcomes
empty
Intervention groups
1
Description
Intervention groups:
Probiotic yogurt in this group hundred cc Kafir (manufactured in Iran) at certain hours of the day drink.
Kafir yogurt and mineral water in containers not show the same content container are produced by individual coding.
Category
Other
2
Description
Control groups:
Patients in this group hundred ml mineral water every day at a specific time of day to drink.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Martyr Rajai Hospital Babolsar
Full name of responsible person
Sahar Latifi
Street address
Shahid Rajaee Hospital Babolsar, Shariati Street
City
Babolsar
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for Research and Technology, Babol University of Medical Sciences
Full name of responsible person
Dr. Ali Bijani
Street address
Babol University of Medical Sciences, Ganjafroz Avenu
City
Babol
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 and Technology, Babol 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
Dental colleges of Babol
Full name of responsible person
Sahar Latifi
Position
Dental students
Other areas of specialty/work
Street address
Dental colleges of Babol, Babol University of Medical Sciences, Ganjafroz Avenue
City
Babol
Postal code
Phone
+98 11 3229 1408
Fax
Email
asemoon2012@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Dental colleges of Babol
Full name of responsible person
Dr. Mohammad Mehdizadeh
Position
Maxillofacial surgery
Other areas of specialty/work
Street address
Dental colleges of Babol, Babol University of Medical Sciences, Ganjafroz Avenue
City
Babol
Postal code
Phone
+98 11 3229 1408
Fax
Email
Dr.rmohammad@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Nargess Gholizadeh Pasha
Position
MSc
Other areas of specialty/work
Street address
Babol University of Medical sciences, Ganjafroz Avenue
City
Babol
Postal code
Phone
Fax
Email
ngh_pa@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)