This study was designed to assess how the early and late phases the disease is sensitive to the probiotic supplementation. In addition to the MMSE cognitive test, measurement of inflammatory factors including Il-6, IL-10, TNF-α and some metabolic parameters are under focus of the present work.The participants are randomly selected (as multi center) from the welfare centers located in Tehran, Kashan and Aran – Bidgol. The sample size is adjust according to sample size formula and previous study; accordingly 60 patients are divided in two control (receiving maltodextrin) and test (receiving probiotic) groups with 30 people in each group. The major criterion for entering the study is Alzheimer associated memory disorder diagnosed by a neurologist through the Mini-Mental State Examination (MMSE) test. The experimenters are blind to the control and test groups during the supplement administration, behavioral test and measuring the inflammatory factors. Hence the investigation will be performed as double blind study. The interventions are administering either maltodextrin (in the control group) or probiotic (in the test group). The primary and secondary variables are the MMSE scores and the serum inflammatory factors, respectively.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017061534549N1
Registration date:2017-10-24, 1396/08/02
Registration timing:retrospective
Last update:
Update count:0
Registration date
2017-10-24, 1396/08/02
Registrant information
Name
Mahmoud Salami
Name of organization / entity
Kashan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 5562 1157
Email address
salami-m@kaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Kashan University of Medical Sciences - Deputy of Research
Zist Takhmir Company
Expected recruitment start date
2017-04-21, 1396/02/01
Expected recruitment end date
2017-08-23, 1396/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of probiotic supplementation on cognitive function and inflammatory markers in patients with early and late phases of Alzheimer's disease
Public title
The effect of probiotic supplementation on cognitive function and inflammatory markers in patients with early and late phases of Alzheimer's disease
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: The patients will be categorized based on the Mini Mental State Examination (MMSE) test, age (65-90) and sex.
Exclusion criteria: any disease other than the cognitive problems in the patients such as metabolic disorders
Age
From 65 years old to 90 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethical commitee of Kashan University of Medical Sciences
Street address
Physiology Research Center, Kashan University of Medical Sciences
City
Kashan
Postal code
Approval date
2017-05-31, 1396/03/10
Ethics committee reference number
IR.kaums.rec.1396.42
Health conditions studied
1
Description of health condition studied
Alzheimer,s disease
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Memory (based on Mini Mental State Examination test)
Timepoint
before and after 4 months of intervantion
Method of measurement
Interview
Secondary outcomes
1
Description
Serum inflammatory factors
Timepoint
Before and 4 months after intervention
Method of measurement
measurments in serum through Elisa kits
Intervention groups
1
Description
Intervention group: Probiotics
-Including : Bididobacterium lactis,Bifidobacterium bifidum,Bifidobacterium longum
And Lactobacillus plantarum,Lactobacillus fermentum, Lactobacillus acidophilus ،
each person receiving one capsule/day-
Each capsule containing 9000000000 bacteria –
-duration of treatment: 4 months
- product of Zyst Takhmir and Milad Biopharmed Companies
Category
Treatment - Drugs
2
Description
Control group: Maltodextrin
-Including orligosacharide with alpha- 1,4 and alpha 1,6 bonds
Capsulated maltodextrine -
each person receiving one capsule/day –
-duration of treatment: 4 months
- product of Milad Biopharmed Company
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Golabchi Welfare Organization
Full name of responsible person
Street address
City
Kashan
2
Recruitment center
Name of recruitment center
Miaad Welfare Organization
Full name of responsible person
Street address
City
Kashan (Ravand)
3
Recruitment center
Name of recruitment center
Imam Ali (PBOH) Welfare Organization
Full name of responsible person
Street address
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Mahmoud Salami
Street address
Physiology Research Center, Kashan University of Medical Sciences
City
Kashan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kashan 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
2
Sponsor
Name of organization / entity
Zist Takhmir Company
Full name of responsible person
Mrs. Tajik
Street address
Resalat Square, Tehran
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Zist Takhmir Company
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
Kashan University of Medical Sciences
Full name of responsible person
Dr. Mahmoud Salami
Position
Head of Physiology Research Center-PhD
Other areas of specialty/work
Street address
Physiology Research Center- Kashan University of Medical Sciences-
City
Kashan
Postal code
Phone
+98 31 5562 1157
Fax
Email
salami-m@kaums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Physiology Research Center, Kashan University of Medical Sciencess
Full name of responsible person
Dr. Mahmoud Salami
Position
Head of Physiology Research Center, PhD
Other areas of specialty/work
Street address
Physiology Research Center, Kashan University of Medical Sciences
City
Kashan
Postal code
Phone
00
Fax
Email
salami-m@kaums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Full name of responsible person
Azam Alinaghipour
Position
Other areas of specialty/work
Street address
City
Postal code
Phone
00
Fax
Email
a.anp20@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)