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The effect of probiotic supplementation on cognitive, inflammation and oxidative stress in adults with Alzheimer disease: A randomized, double blind, placebo-controlled trial

Protocol summary

Study aim
Determining the effect of Lactobacillus rhamnosus HA-114 and Bifidobacterium longum R0175 probiotic supplements on cognitive function, inflammatory markers and oxidative stress in Alzheimer's patients
Design
Clinical trial, with a control and two intervention groups, parallel groups, double-blind, randomized, phase 3 on 90 patients, stratified permute block randomization in two classes based on (age and sex) using It will be done from www.randomization.com.
Settings and conduct
probiotic supplementation for 12 weeks will be performed on 3 groups of 30 people with Alzheimer's in neurology clinics of hospitals affiliated to Tehran University of Medical Sciences. . Supplements are coded by the company and researchers and participants are unaware of which supplement receives which group until the end of the analysis.
Participants/Inclusion and exclusion criteria
Inclusion criteria: 1.Age 80-50 years 2.Resident of Tehran 3.Diagnosis of Alzheimer's disease 4.Kg/m2 30- 5/18 BMI= 5.Use of Alzheimer's drugs 6.consent of caregivers Criteria for non-entry: 1.Do not live in Tehran 2.Having dementia 3.Take antibiotics 4.Smoking 5.Any drug addiction 6.Follow a specific diet 7.Participate in another study 8.Take supplements or food products fortified with pre/ probiotics 9.History of serious disease 10.History of major gastrointestinal surgeries
Intervention groups
3 groups consisting of 30 Alzheimer's patients. The first group will receive 2 probiotic capsules containing 1 Lactobacillus rhamnosus HA-114 bacterial strain of CFU 1015 daily. Patients in the second group will receive 2 probiotic capsules containing 1 Bifidobacterium longum R0175 bacterial strain daily at the amount of CFU 1015 and the third group will receive 2 placebo capsules containing xylitol, maltodextrin and malic acid.
Main outcome variables
cognitive function

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20210513051277N1
Registration date: 2021-05-27, 1400/03/06
Registration timing: prospective

Last update: 2021-05-27, 1400/03/06
Update count: 0
Registration date
2021-05-27, 1400/03/06
Registrant information
Name
Camellia Akhgarjand
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8895 5975
Email address
kameliaakhgarjand@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-06-22, 1400/04/01
Expected recruitment end date
2022-06-22, 1401/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of probiotic supplementation on cognitive, inflammation and oxidative stress in adults with Alzheimer disease: A randomized, double blind, placebo-controlled trial
Public title
The effect of probiotic supplementation on cognitive function in Alzheimer's patients
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Age 80-50 years Resident of Tehran Diagnosis of Alzheimer's disease according to NINCDS-ARDA criteria maximum in the last 2 years BMI=18/5-30 Kg/m2 Use of acetylcholinesterase inhibitors (AchEIs) and N-methyl dispartate (NMDA) receptor antagonists caregivers understands the objectives of the study and agrees to follow the necessary rules throughout the study
Exclusion criteria:
Having frontotemporal dementia, Levy Buddy dementia, Parkinson's disease dementia and any type of severe dementia Take antibiotics at least three months before enrollment Smoking (at least 5 cigarettes a day for the past 6 months) and other tobacco (pipe and hookah at least once a month Any drug addiction Follow a specific diet for three months before the study People who participated in another study less than two months ago. Take any amount of supplements or foods fortified with fins or probiotics during the last 3 months History of serious kidney, liver, intestinal, endocrine diseases, cardiovascular, gastrointestinal, pulmonary, blood and metabolic diseases, thyroid, rheumatoid arthritis and lupus History of major gastrointestinal surgeries including gastrectomy, bowel restriction, etc.
Age
From 50 years old to 80 years old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
  • Care provider
  • Investigator
  • Outcome assessor
  • Data analyser
  • Data and Safety Monitoring Board
Sample size
Target sample size: 30
Randomization (investigator's opinion)
Randomized
Randomization description
Stratified permute block randomization will be performed in two categories based on (age and sex) using the site www.randomization.com. In this method, each group is assigned one of the letters A, B and C and randomization will be done in 6 blocks. This is done for both age groups and two lists are prepared based on age and gender. Within each class, patients will be randomly assigned to one of the three study groups in a 1: 1: 1 ratio.
Blinding (investigator's opinion)
Double blinded
Blinding description
All supplements will be provided by Lallemand Canada and are similar in color, taste and size. Supplements are coded by the company, and researchers, participants, data collectors and analysts, and the Data Safety and Supervision Committee are unaware of which group receives which supplement.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Tehran University of Medical Sciences
Street address
Keshavarz Blvd
City
Tehran
Province
Tehran
Postal code
1417653911
Approval date
2021-05-15, 1400/02/25
Ethics committee reference number
IR.TUMS.MEDICINE.REC.1400.152

Health conditions studied

1

Description of health condition studied
Alzheimer disease
ICD-10 code
G30
ICD-10 code description
Alzheimer's disease

Primary outcomes

1

Description
cognitive function
Timepoint
Measurement of cognitive function at the beginning of the intervention (before the start of the intervention) and the end of week 12
Method of measurement
Mini–Mental State Examination questionnaire

Secondary outcomes

1

Description
serum level of IL-6
Timepoint
at the beginning of the intervention (before the start of the intervention) and the end of week 12
Method of measurement
Double Antibody Sandwich

2

Description
serum level of interleukin-10
Timepoint
at the beginning of the intervention (before the start of the intervention) and the end of week 12
Method of measurement
enzyme-linked immunosorbent assay

3

Description
serum level 0f TNF-α
Timepoint
at the beginning of the intervention (before the start of the intervention) and the end of week 12
Method of measurement
Quantitative Sandwich

4

Description
serum level of 8-hydroxy-2' -deoxyguanosine (8-OHdG)
Timepoint
at the beginning of the intervention (before the start of the intervention) and the end of week 12
Method of measurement
Double Antibody Sandwich

5

Description
Serum levels of malondialdehyde (MDA)
Timepoint
at the beginning of the intervention (before the start of the intervention) and the end of week 12
Method of measurement
Colorimetric

6

Description
Serum level of glutathione
Timepoint
at the beginning of the intervention (before the start of the intervention) and the end of week 12
Method of measurement
Quantitative Sandwich

7

Description
Serum kynurenine levels
Timepoint
at the beginning of the intervention (before the start of the intervention) and the end of week 12
Method of measurement
Quantitative Sandwich

8

Description
Serum tryptophan levels
Timepoint
at the beginning of the intervention (before the start of the intervention) and the end of week 12
Method of measurement
Fluorometric

9

Description
Serum levels of lipopolysaccharide
Timepoint
at the beginning of the intervention (before the start of the intervention) and the end of week 12
Method of measurement
quantitative sandwich enzyme immunoassay

10

Description
physical activity
Timepoint
at the beginning of the intervention (before the start of the intervention) and the end of week 12
Method of measurement
questionnaire

11

Description
Quality of Life
Timepoint
at the beginning of the intervention (before the start of the intervention) and the end of week 12
Method of measurement
Quality of life in Alzheimer disease questionnaire (QOL-AD)

Intervention groups

1

Description
Intervention group: Patients in the first group will receive 2 probiotic capsules daily containing 1 bacterial strain of Lactobacillus rhamnosus HA-114 in the amount of CFU 1015. All supplements will be provided by Lallemand Canada and are similar in color, taste and size. Take 2 capsules daily, one after lunch and one after dinner. Supplements will be delivered to patients in two stages (study start and week 6).
Category
Other

2

Description
Intervention group: Patients in the second group will receive 2 probiotic capsules daily containing 1 bacterial strain of Bifidobacterium longum R0175 in the amount of CFU 1015. All supplements will be provided by Lallemand Canada and are similar in color, taste and size. Take 2 capsules daily, one after lunch and one after dinner. Supplements will be delivered to patients in two stages (study start and week 6).
Category
Other

3

Description
Control group: Patients in the intervention group will receive 2 placebo capsules daily containing xylitol, maltodextrin and malic acid. All supplements will be provided by Lallemand Canada and are similar in color, taste and size. Take 2 capsules daily, one after lunch and one after dinner. Supplements will be delivered to patients in two stages (study start and week 6).
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Imam Khomeini hospital
Full name of responsible person
Camellia Akhgarjand
Street address
Keshavarz Blvd
City
Tehran
Province
Tehran
Postal code
۱۴۱۹۷۳۳۱۴۱
Phone
+98 21 6693 9009
Email
Imamhospital@tums.ac.ir
Web page address

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Mohammad Ali Sahraeian
Street address
Keshavarz Blvd
City
Tehran
Province
Tehran
Postal code
1417653911
Phone
+98 21 8163 3698
Email
vcr@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
Camellia Akhgarjand
Position
PhD student
Latest degree
Master
Other areas of specialty/work
Nutrition
Street address
Keshavarz Blvd
City
Tehran
Province
Tehran
Postal code
1417653911
Phone
+98 21 8895 5975
Email
kameliaakhgarjand@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Kurosh Djafarian
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Keshavarz Blvd
City
Tehran
Province
Tehran
Postal code
1417653911
Phone
+98 21 8895 5975
Email
kdjafarian@tums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Camellia Akhgarjand
Position
PhD student
Latest degree
Master
Other areas of specialty/work
Nutrition
Street address
Keshavarz Blvd
City
Tehran
Province
Tehran
Postal code
1417653911
Phone
+98 21 8895 5975
Email
kameliaakhgarjand@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
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