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Synbiotic supplementation on gut microbiome metabolite, inflammatory and cardiovascular factors in mild subclinical hypothyroid patients: A double-blind placebo-controlled randomized clinical trial

Protocol summary

Study aim
Determining the effect of synbiotic supplementation on gut microbiome metabolites and some inflammatory and cardiovascular factors in mild subclinical hypothyroid patients
Design
A randomized double-blind controlled,clinical trial with parallel-group, on 48 patients.
Settings and conduct
The study will be conducted at Sina hospital of Tabriz University of Medical Sciences and the supplementation duration will be 8 weeks. The Synbiotic and placebo packages will be coded by the person responsible for preparing them, and the main investigators and the patients will be blinded to the type of supplement each group receives.
Participants/Inclusion and exclusion criteria
Inclusion criteria: newly diagnosed patients with subclinical hypothyroidism, TSH level between 4 and 10 IU/ml, age between 20-65 years, willingness to cooperate in the project, suffering from mild subclinical hypothyroidism. Exclusion criteria: hormone therapy and use of hormonal drugs, contraceptive drugs, anti-inflammatory drugs, blood lipid-lowering drugs, use of any probiotic supplements in the last 3 months before the study and during the study, use of Antibiotics during the study
Intervention groups
The intervention group received 1 synbiotic capsule daily with a microbial load of 109 CFU after lunch, and the placebo group also received 1 placebo capsule daily, which includes cellulose, non-absorbable silicon dioxide, prepared in the Faculty of Pharmacy after lunch for 2 months (60 day).
Main outcome variables
Intestinal microbiome metabolite (LPS), cardiovascular indices (TC, LDL, apoA1, Apo B), IL-6 and TNF-α

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20121224011867N2
Registration date: 2024-05-28, 1403/03/08
Registration timing: prospective

Last update: 2024-05-28, 1403/03/08
Update count: 0
Registration date
2024-05-28, 1403/03/08
Registrant information
Name
Naimeh Mesri Alamdari
Name of organization / entity
Faculty of Health and Nutrition, Tabriz University Of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1335 7580
Email address
mesri65@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-08-22, 1403/06/01
Expected recruitment end date
2024-11-20, 1403/08/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Synbiotic supplementation on gut microbiome metabolite, inflammatory and cardiovascular factors in mild subclinical hypothyroid patients: A double-blind placebo-controlled randomized clinical trial
Public title
Investigating the effect of synbiotics in mild subclinical hypothyroid patients
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Newly diagnosed patients with mild subclinical hypothyroidism TSH level between 4 and 10 IU/ml Willingness to cooperate in the project 20-65 years Suffering from mild subclinical hypothyroidism
Exclusion criteria:
Hormone therapy and the use of hormonal drugs The contraceptive drugs usage The anti-inflammatory drugs usage The blood lipid-lowering drugs consumption The probiotic supplements consumption in the last 3 months before the study and during the study The antibiotic drugs usage during the study Sُynbiotic supplement intolerance during the study Immune system disorders Immunosuppressive drugs or chemotherapy consumption Cardiovascular diseases, active ulcerative colitis, short bowel syndrome, acute and chronic infectious diseases History of drug or food allergies Pregnancy and breastfeeding Smoking Alcohol consumption
Age
From 20 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Participant
  • Outcome assessor
Sample size
Target sample size: 48
Randomization (investigator's opinion)
Randomized
Randomization description
Subjects are randomly assigned 1:1 into 2 intervention and placebo groups. Allocation to study groups is done based on permuted block randomization using RAS software and on random blocks that will be matched in age and sex.
Blinding (investigator's opinion)
Double blinded
Blinding description
This study's main investigator and patients will be blind (synbiotic or placebo). The person is responsible for preparing the supplement (who is completely unrelated to the study) will be asked to assign a three-digit code to each of the two supplements (synbiotic and placebo) and keep the codes for himself until the end of the study and data analyses.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Research Ethics Committees of Tabriz University of Medical Sciences
Street address
Third Floor, Central Building (2), Tabriz University of Medical Sciences, Golghasht Street
City
Tabriz
Province
East Azarbaijan
Postal code
00984133344280
Approval date
2024-04-22, 1403/02/03
Ethics committee reference number
IR.TBZMED.REC.1403.052

2

Ethics committee
Name of ethics committee
Research Ethics Committees of Tabriz University of Medical Sciences
Street address
Third Floor, Central Building (2), Tabriz University of Medical Sciences, Golghasht Street
City
Tabriz
Province
East Azarbaijan
Postal code
00984133344280
Approval date
2024-04-22, 1403/02/03
Ethics committee reference number
IR.TBZMED.REC.1403.052

Health conditions studied

1

Description of health condition studied
Mild subclinical hypothyroidism
ICD-10 code
E02
ICD-10 code description
Subclinical iodine-deficiency hypothyroidism

Primary outcomes

1

Description
Gut microbiome metabolite (LPS)
Timepoint
Before the intervention and two months after the intervention
Method of measurement
By laboratory ELISA kits

Secondary outcomes

1

Description
Total cholesterol (TC)
Timepoint
Before the intervention and two months after the intervention
Method of measurement
By laboratory ELISA kits

2

Description
Triglyceride (TG)
Timepoint
Before the intervention and two months after the intervention
Method of measurement
By laboratory ELISA kits

3

Description
Apo A1
Timepoint
Before the intervention and two months after the intervention
Method of measurement
By laboratory ELISA kits

4

Description
Apo B
Timepoint
Before the intervention and two months after the intervention
Method of measurement
By laboratory ELISA kits

Intervention groups

1

Description
Intervention group: synbiotic capsule which contains bacterial species Lactobacillus rhamnoses, Lactobacillus plantarum, Lactobacillus casei, Lactobacillus helveticus, Lactobacillus acidophilus, Lactobacillus bulgaricus, Lactobacillus gasseri, Bifidobacterium bifidum, Bifidobacterium lactis, Bifidobacterium breve. , Bifidobacterium longum, Streptococcus thermophile and prebiotic fructooligosaccharide with a microbial load of 109 CFU after lunch once a day.
Category
Prevention

2

Description
Control group: The placebo group will receive 1 placebo capsule per day, which includes cellulose compounds, non-absorbable silicon dioxide prepared in the Faculty of Pharmacy, after lunch for 2 months (60 days).
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
Health centers of Tabriz University of Medical Sciences
Full name of responsible person
Naimeh Mesri Alamdari
Street address
Endocrine Research Center, Nutrition faculty, Attar Neyshabouri Street, Golgasht Avenue, CityTabriz
City
Tabriz
Province
West Azarbaijan
Postal code
5166614711
Phone
+98 41 3334 8939
Email
mesri65@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Research vice- chancellor of Tabriz university of medical sciences
Full name of responsible person
Parviz Shahabi
Street address
Golgasht St
City
Tabriz
Province
East Azarbaijan
Postal code
5166616471
Phone
+98 41 3335 7311
Email
parvizshahabi@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Research vice- chancellor of Tabriz 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
Tabriz University of Medical Sciences
Full name of responsible person
Naimeh Mesri Alamdari
Position
academic board
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Endocrine Research Center, Nutrition Faculty, Attar Neishabouri Street, Golgasht Avenue
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Phone
009833348939
Email
mesri65@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Naimeh Mesri Alamdari
Position
Academic Board
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
ٍEndocrine Research Center, Nutrition Faculty, Attar Neishabouri Street, Golgasht Avenue
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Phone
009833348939
Email
mesri65@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Naimeh Mesri Alamdari
Position
Academic board
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Endocrine Research Center, Nutrition Faculty, Attar Neishabouri Street, Golgasht Avenue
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Phone
+98 41 3334 8939
Email
mesri65@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is 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
Title and more details about the data/document
Data collected for the primary outcomes will be shared.
When the data will become available and for how long
access starting 12 months after publication
To whom data/document is available
The data will only be available for people working in academic institutions.
Under which criteria data/document could be used
The data of the present study will only be accessible by other researchers, for conducting Meta-analysis.
From where data/document is obtainable
To receive the data, contact the project manager (Naimeh Masri Alamdari). Postal address: Tabriz University of Medical Sciences - Endocrine Research Center Email: mesri65@gmail.com Academic email: n.mesri@tbzmed.ac.ir
What processes are involved for a request to access data/document
mesri65@gmail.com n.mesri@tbzmed.ac.ir
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