Evaluation of Lactocare probiotic effects on the immune system in patients with type II diabetes

Evaluation of therapeutic effects of lactocare® probiotic on clinical symptoms, frequency of T cell subsets and expression of HOTAIR and MEG3 genes in patients with type II diabetes in comparison with control group

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

IRCT

Registry ID

IRCT20220727055564N1

Enrollment

Registered

2022-08-04

Start date

2022-10-23

Completion date

Unknown

Last updated

2022-08-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

type 2 diabetes. Type 2 diabetes without complications

Interventions

Intervention 1: Intervention group: One capsule of lactocare probiotic, daily for 90 days. Intervention 2: Control group: one capsule of placebo daily for 90 days.

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Having a willingness and informed consent to participate in the study Having clinical symptoms of type 2 diabetes Confirmation of type 2 diabetes based on clinical symptoms and diagnostic tests by a specialist doctor No recent history of inflammatory diseases No history of receiving anti-inflammatory drugs No history of taking corticosteroid drugs Absence of immune system diseases and immune deficiencies

Exclusion criteria

Exclusion criteria: History of heart diseases including: blood pressure, heart failure, heart attack in the last month History of autoimmune diseases including: type 1 diabetes, multiple sclerosis, MS, lupus erythematosus, various types of vasculitis, rheumatism, Crohn's disease, etc. History of liver diseases including: liver cirrhosis and hepatitis in the past year History of underlying lung diseases such as: asthma, bronchiolitis, respiratory allergies, bronchiectasis, COPD History of organ transplant in the last three months People with a history of alcohol consumption Taking immunosuppressive drugs

Design outcomes

Primary

Measure	Time frame
Frequency of regulatory T cell population. Timepoint: Measurement of the frequency of regulatory T cells at the beginning of the study (before the start of the intervention) and 3 months after the start of lactocare probiotic or placebo. Method of measurement: Regulatory T, a cell effective in protecting inflammatory responses, with foxp3 factor measured by flow cytometry.;Maternal expressed gene 3 (lnc-MEG3). Timepoint: Measurement of the lnc-MEG3 gene expression level at the beginning of the study (before the start of the intervention) and 3 months after the start of taking lactocare probiotic drug or placebo. Method of measurement: Investigating the expression level of lnc-MEG3, which is an LncRNA that affects the functions of the immune system, compared to U6 small nuclear 1 is measured by real time PCR method.;Gene Expression (lnc-HOTAIR) HOX Transcript Antisense RNA. Timepoint: Measurement of the lnc-HOTAIR gene expression level at the beginning of the study (before the start of the intervention) and 3 months after the start of taking lactocare probiotic drug or placebo. Method of measurement: Investigating the level of expression of lnc-HOTAIR, which is an LncRNA that affects the functions of the immune system, compared to U6 small nuclear 1, is measured by real time PCR method.;Triglyceride (TG). Timepoint: Measuring the amount of triglycerides at the beginning of the study (before the start of the intervention) and 3 months after the start of taking lactocare probiotic drug or placebo. Method of measurement: Triglyceride is a form of fat storage in the blood circulation that is measured by an enzyme method.;Cholesterol (CHOL). Timepoint: Cholesterol measurement at the beginning of the study (before the start of the intervention) and 3 months after the start of lactocare probiotic drug or placebo. Method of measurement: Total cholesterol in LDL, VLDL and HDL particles in blood circulation, which is measured by enzyme method.;Low-density lipoprotein (LDL-c	—

Measure

Time frame

Frequency of regulatory T cell population. Timepoint: Measurement of the frequency of regulatory T cells at the beginning of the study (before the start of the intervention) and 3 months after the start of lactocare probiotic or placebo. Method of measurement: Regulatory T, a cell effective in protecting inflammatory responses, with foxp3 factor measured by flow cytometry.;Maternal expressed gene 3 (lnc-MEG3). Timepoint: Measurement of the lnc-MEG3 gene expression level at the beginning of the study (before the start of the intervention) and 3 months after the start of taking lactocare probiotic drug or placebo. Method of measurement: Investigating the expression level of lnc-MEG3, which is an LncRNA that affects the functions of the immune system, compared to U6 small nuclear 1 is measured by real time PCR method.;Gene Expression (lnc-HOTAIR) HOX Transcript Antisense RNA. Timepoint: Measurement of the lnc-HOTAIR gene expression level at the beginning of the study (before the start of the intervention) and 3 months after the start of taking lactocare probiotic drug or placebo. Method of measurement: Investigating the level of expression of lnc-HOTAIR, which is an LncRNA that affects the functions of the immune system, compared to U6 small nuclear 1, is measured by real time PCR method.;Triglyceride (TG). Timepoint: Measuring the amount of triglycerides at the beginning of the study (before the start of the intervention) and 3 months after the start of taking lactocare probiotic drug or placebo. Method of measurement: Triglyceride is a form of fat storage in the blood circulation that is measured by an enzyme method.;Cholesterol (CHOL). Timepoint: Cholesterol measurement at the beginning of the study (before the start of the intervention) and 3 months after the start of lactocare probiotic drug or placebo. Method of measurement: Total cholesterol in LDL, VLDL and HDL particles in blood circulation, which is measured by enzyme method.;Low-density lipoprotein (LDL-c

—

Secondary

Measure	Time frame
Clinical symptoms of patients with type 2 diabetes mellitus in the studied groups. Timepoint: The clinical symptoms of patients with type 2 diabetes will be measured at the beginning of the study (before the intervention) and 90 days after the start of lactocare probiotic medicine. Method of measurement: The clinical symptoms of type 2 diabetes patients will be measured by examining nutrition (in terms of consumption or non-consumption of probiotic products), culture (having or not having eating and social habits) by an internal medicine specialist or an endocrinologist.	—

Measure

Time frame

Clinical symptoms of patients with type 2 diabetes mellitus in the studied groups. Timepoint: The clinical symptoms of patients with type 2 diabetes will be measured at the beginning of the study (before the intervention) and 90 days after the start of lactocare probiotic medicine. Method of measurement: The clinical symptoms of type 2 diabetes patients will be measured by examining nutrition (in terms of consumption or non-consumption of probiotic products), culture (having or not having eating and social habits) by an internal medicine specialist or an endocrinologist.

—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactMahdi Atabaki

Zahedan University of Medical Sciences

atabaki80@gmail.com+98 54 3337 2151

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026