Effect of oral probiotic supplements on cognitive status, activity of daily living (ADL) and metabolic index in demented elderly: A randomized, double-blind, placebo-controlled trial
Determining the effect of oral probiotic supplements on cognitive status, activity of daily living (ADL) and metabolic index in demented elderly
Design
Clinical trials with control group, with parallel groups, blind, randomized
Sample size: 68 people (34 people per group)
Settings and conduct
The study is a double-blind randomized clinical trial that evaluates the effect of probiotic supplementation on cognitive status, activities of daily living and metabolic parameters in demented elderly patients during a period of 12 weeks. All patients aged 60 and older with dementia in mild or moderate stage, who refer to multidisciplinary clinic at Ziaeian hospital in Tehran, enter into the study.A member of the research team who is blind about the content of capsules and the group of every individual, gives each patient 60 capsules monthly, up to 3 months
Participants/Inclusion and exclusion criteria
Inclusion criteria: All patients aged 60 and older, with dementia in mild or moderate stage who evaluated based on “(NIA-AA) 2011
Exclusive Criteria:1.Chronic infections2.Consumption probiotics
3.Taking antibiotics 4. severe gastrointestinal diseases
5.Alcohol consumption 6.severe heart disease, severe renal or liver impairment
7.Patients with frontotemporal dementia (FTD), dementia with Lewy bodies (DLB), Parkinson’s disease dementia (PDD) and any demented patients in severe stage8.Unwillingness to continue
9.Occurrence of delirium, stroke, prolonged hospitalization or inactivity and any diseases that affect cognitive or physical function
Intervention groups
The intervention group received oral probiotic supplements and the control group received placebo randomly.
Main outcome variables
Mini Mental State Examination (MMSE)؛ Functional assessment staging (FAST)؛ Barthel Index؛ TG، Total Chol، HDL،LDL، FBS، Alb، Vit D
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20191008045024N1
Registration date:2019-12-28, 1398/10/07
Registration timing:registered_while_recruiting
Last update:2019-12-28, 1398/10/07
Update count:0
Registration date
2019-12-28, 1398/10/07
Registrant information
Name
Shima Raeesi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 5517 6031
Email address
shraeesi@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-10-23, 1398/08/01
Expected recruitment end date
2020-10-22, 1399/08/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of oral probiotic supplements on cognitive status, activity of daily living (ADL) and metabolic index in demented elderly: A randomized, double-blind, placebo-controlled trial
Public title
Effect of Probiotics Supplementation on Cognitive Status, Daily Life Function and Metabolic Indexes
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
patients aged 60 and older
According to the 2011NIA-AA criteria for dementia in the mild to moderate stage
Obtaining informed consent
Exclusion criteria:
Chronic infections
Consumption any products that contain probiotics or prebiotics during the recent 6 months
Taking any kind of antibiotics during the month before starting the study
History of any severe gastrointestinal diseases including celiac disease, inflammatory bowel diseases and diverticulitis or gastrointestinal surgery
Alcohol consumption during 1 month before
Suffering from severe heart disease, severe renal or liver impairment
Patients with frontotemporal dementia (FTD), dementia with Lewy bodies (DLB), Parkinson’s disease dementia (PDD) and any demented patients in severe stage, are also excluded because of their different nature and progression manner
Occurrence of delirium at the beginning of the study
Age
From 60 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Investigator
Data analyser
Sample size
Target sample size:
68
Randomization (investigator's opinion)
Randomized
Randomization description
Patients will be divided into two groups, case and control groups, using permuted block randomization. We use the website http:/ /www.sealedenvelope.com for creation a random sequence in block randomization approach. It also advocates at specific sure to hide the allocation concealment. A number (specific code) is defined for each drug box according to the random sequence created. Based on the order of participant’s entrance to the study and the random number, each patient is divided into case or control group and receives probiotics supplementation or placebo, respectively.
Blinding (investigator's opinion)
Double blinded
Blinding description
A member of the research team who is blind about the content of capsules and the group of every individual, gives each patient 60 capsules monthly, up to 3 months. Participants are requested to take two capsules each day. Patients in intervention group receive probiotic containing capsules and in control group, they receive placebo, which are exactly similar in appearance (including shape, size and color) and indistinguishable from probiotic containing capsules.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee on Biomedical Research of Tehran University of Medical Sciences
Street address
Tehran University of Medical Sciences, Qods Corner, Keshavarz Blvd.
City
Tehran
Province
Tehran
Postal code
1366736511
Approval date
2019-05-25, 1398/03/04
Ethics committee reference number
IR.TUMS.MEDICINE.REC.1398.132
Health conditions studied
1
Description of health condition studied
Dementia
ICD-10 code
F01
ICD-10 code description
Vascular dementia
2
Description of health condition studied
Alzheimer's disease
ICD-10 code
G30
ICD-10 code description
Alzheimer's disease
Primary outcomes
1
Description
Mini Mental State Examination
Timepoint
The beginning of the study - 3 months later
Method of measurement
Mini Mental State Examination (MMSE) test
2
Description
Functional assessment staging
Timepoint
The beginning of the study - 3 months later
Method of measurement
Functional assessment staging test (FAST)؛ Barthel Index
3
Description
Metabolic status
Timepoint
The beginning of the study - 3 months later
Method of measurement
Chek Serum TG، Total Chol، HDL،LDL، FBS، Alb، Vit D
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: 68 patients receive 60 probiotic capsules (2 capsules daily for one month) and this continues for three months. Each probiotic capsule contains 500 mg and contains seven beneficial bacterial strains.The probiotic supplement is manufactured by “Zist Takhmir pharmaceutical company” in Tehran, Iran.
Category
Treatment - Drugs
2
Description
Intervention group: 68 patients receive 60 placebo capsules (2 capsules daily for one month) and this continues for three months. Each placebo capsule is similar to the probiotic capsule in Shape, size and color. The placebo is manufactured by “Zist Takhmir pharmaceutical company” in Tehran, Iran.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Ziaeian Hospital
Full name of responsible person
Shima Raeesi
Street address
Ziaeian Hospital, Aboozar Street
City
Tehran
Province
Tehran
Postal code
1366736511
Phone
+98 21 5517 6031
Email
shimaraeesi@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr Mohammad Ali Sahraian
Street address
Tehran University of Medical Sciences, Qods Corner, Keshavarz Blvd.
City
Tehran
Province
Tehran
Postal code
1366736511
Phone
+98 21 8898 7381
Email
resdeputy@tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Shima Raeesi
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Geriatrics
Street address
Ziaeian Hospital, lower than Aboozar Square, Aboozar Street
City
Tehran
Province
Tehran
Postal code
1366736511
Phone
+98 21 5517 6031
Fax
Email
shraeesi@sina.tums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Shima Raeesi
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Geriatrics
Street address
Ziaeian Hospital, lower than Aboozar Square, Aboozar Street
City
Tehran
Province
Tehran
Postal code
1366736511
Phone
+98 21 5517 6031
Fax
Email
shraeesi@sina.tums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mahdieh Mehmandoost
Position
Assistant
Latest degree
Medical doctor
Other areas of specialty/work
Geriatrics
Street address
Ziaeian Hospital, lower than Aboozar Square, Aboozar Street
City
Tehran
Province
Tehran
Postal code
1366736511
Phone
+98 21 5517 6031
Email
mehmandoost_tums96@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available