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Evaluation of the Effect of combination Lactobacillus casei, Lacticaseibacillus rhamnosus, and Lactobacillus acidophilus Probiotics on Blood Cholesterol Levels in Patients with Mild Hypercholesterolemia Compared to a Control Group.

Protocol summary

Study aim
• Determining the effect of of combination Lactobacillus casei, Lacticaseibacillus rhamnosus, and Lactobacillus acidophilus Probiotics on blood cholesterol levels.
Design
randomized clinical trial with control group, double blinded, phase 3 with 104 patients randomized to A AND B group according to medication box label.
Settings and conduct
the study will be done in family medicine clinic of shiraz university of medical sciences. the patients who had been visited by attendings of internal medicine and family medicine who have high blood cholesterol levels would be referred to family medicine resident to evaluate the inclusion criteria and if the patient has the criteria randomly be divided in 2 groups of A & B. then after 2 weeks of Mediterranean diet , they would receive medication with the same label as group number. after daily use for 6 weeks , blood cholesterol level will be checked and after analysis, comparison of two groups would be done.
Participants/Inclusion and exclusion criteria
inclusion criteria: adult 18-65 years old with mild hypercholesterolemia total cholesterol 220-280 mg/dl) who do not have sever medical conditions ( cancer,..) or do not need lipid lowering medication for other reasons . also no contraindication for probiotic usage .exclusion as mentioned above
Intervention groups
case group : after 2 weeks of Mediterranean diet ,daily use of combination capsule of probiotics Lactobacillus casei, Lacticaseibacillus rhamnosus, and Lactobacillus acidophilus for six weeks and then reevaluation of lipid levels. Control group: after 2 weeks of Mediterranean diet ,daily use of placebo capsule with the same shape for 6 weeks and then reevaluation of blood cholesterol levels.
Main outcome variables
Total cholesterol, HDL cholesterol, LDL cholesterol, Triglycerides

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20240512061765N1
Registration date: 2024-07-14, 1403/04/24
Registration timing: prospective

Last update: 2024-07-14, 1403/04/24
Update count: 0
Registration date
2024-07-14, 1403/04/24
Registrant information
Name
fatemeh malekpour
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 3647 4967
Email address
malekpour.f.81@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-07-22, 1403/05/01
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
Evaluation of the Effect of combination Lactobacillus casei, Lacticaseibacillus rhamnosus, and Lactobacillus acidophilus Probiotics on Blood Cholesterol Levels in Patients with Mild Hypercholesterolemia Compared to a Control Group.
Public title
Effect of probiotics on blood lipid level
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
• Adults aged 18-65 years • Individuals with mild hypercholesterolemia(total cholesterol: 5.2-7.5 mmol/L)
Exclusion criteria:
Pregnant or lactating women Individuals on antibiotics or probiotics within the past three months. Individuals with severe health conditions affecting cholesterol metabolism
Age
From 18 years old to 65 years old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
  • Care provider
  • Investigator
Sample size
Target sample size: 82
Randomization (investigator's opinion)
Randomized
Randomization description
En The block randomization list with a block size of 4 is generated by https://www.sealedenvelope.com/simple-randomiser/v1/lists.The sample size, study groups, and size of blocks are given to the system, and the system determines the order of the blocks and the order in each block in a list. The drug and placebo are arranged in a box according to the list by a pharmacist and are given to a doctor who is responsible for the research to be given to the patients.
Blinding (investigator's opinion)
Double blinded
Blinding description
The drug and the placebo are labeled by a pharmacist out of research and the patient, researcher and the doctor don not know the types.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
ethics committee of Shiraz University of Medical Sciences
Street address
family medicine department, Namazi hospital, Karim khan zand avenue, Shiraz, IRAN.
City
shiraz
Province
Fars
Postal code
7193613311
Approval date
2024-06-29, 1403/04/09
Ethics committee reference number
IR.SUMS.MED.REC.1403.177

Health conditions studied

1

Description of health condition studied
MILD HYPERCHOLESTEROLEMIA ( total cholesterol 220-280 mg/dl)
ICD-10 code
E78.0
ICD-10 code description
Pure hypercholesterolemia

2

Description of health condition studied
blood glucose level as beside finding
ICD-10 code
R73.09
ICD-10 code description
Other abnormal glucose

Primary outcomes

1

Description
total cholesterol
Timepoint
before trial and six weeks of medication use
Method of measurement
blood sampling

Secondary outcomes

1

Description
blood glucose level
Timepoint
before trial and after 6 weeks of medication use
Method of measurement
blood sampling

Intervention groups

1

Description
Intervention group: daily use of one capsule of BIO IBS from TAKGENE PHARMA company that contains 5*109 UFC( 5 billion) of of lactobacillus casei , Lacticaseibacillus rhamnosus , Lactobacillus acidophilus for six weeks
Category
Treatment - Drugs

2

Description
Control group: once daily use of placebo capsule with the same shape of original drug, filled with starch , for 6 weeks.
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
family medicine specialty educational clinic, Parvin Dalaki clinical center
Full name of responsible person
Fatemeh Malekpour
Street address
Family medicine specialty clinic ,first floor, Parvin Dalaki clinic, east Fakhr Abad street
City
shiraz
Province
Fars
Postal code
7134733518
Phone
+98 71 3820 8885
Fax
+98 71 3820 8885
Email
malekpour.f.81@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Mohammad Hashem Hashem Pour
Street address
research and technology assistant of Shiraz University of Medical Sciences,7th floor, central building of Shiraz University of Medical Sciences , Karim Khan Zand boulevard
City
shiraz
Province
Fars
Postal code
7134814336
Phone
+98 71 3481 4336
Email
vcrdep@sums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz 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
Shiraz University of Medical Sciences
Full name of responsible person
Fatemeh Malekpour
Position
assistant professor
Latest degree
Specialist
Other areas of specialty/work
Internal Medicine
Street address
family medicine specialty department, Namazi hospital, Karim Khan Zand boulevard
City
Shiraz
Province
Fars
Postal code
7193613311
Phone
+98 71 3647 4967
Email
malekpour.f.81@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Fatemeh Malekpour
Position
assistant professor
Latest degree
Specialist
Other areas of specialty/work
Internal Medicine
Street address
family medicine specialty department , Namazi hospital, Karim Khan Zand boulevard
City
shiraz
Province
Fars
Postal code
7193613311
Phone
+98 71 3647 4967
Email
malekpour.f.81@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Fatemeh Malekpour
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Internal Medicine
Street address
Family medicine department, Namazi educational hospital, shiraz, Iran
City
Shiraz
Province
Fars
Postal code
7193613311
Phone
+98 71 3647 4967
Fax
Email
malekpour.f.81@gmail.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
Not applicable
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Not applicable
Analytic Code
Not applicable
Data Dictionary
Not applicable
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