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The Effect of Lactobacillus Reuteri on Lipid profile in Hypercholesterolemic Adults

The Effect of Lactobacillus Reuteri on Lipid profile in Hypercholesterolemic Adults, a three-blind clinical trial

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20231111060016N1
Enrollment
60
Registered
2023-12-01
Start date
2023-12-06
Completion date
Unknown
Last updated
2024-01-22

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

Conditions

Hypercholesterolemia. Dietary counseling and surveillance

Interventions

Intervention 1: Intervention group: Capsules containing Lactobacillus Rotari in the amount of 5x10^8 CFU- once a day. Intervention 2: Control group: Capsules containing starch.

Sponsors

Mashhad University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
20 Years to 70 Years

Inclusion criteria

Inclusion criteria: THE AGE OF OUR participant will be between 20 to 70 years old; their total cholesterol plasma level will be above 200 mg/dl; HDL-C plasma level under 70 mg/dl; BMI will be between 20 to 45 kg/m2; they should sign informed consent

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
The percentage of patients calculated by SCORE in each group had LDL with a suitable range for lifestyle modification, in the patients of Cardiovascular Clinic of Qaem Hospital. Timepoint: The lipid profile of the patients is measured before the start of the study, 30 days and then 60 days after taking the drugs. Method of measurement: Initial lipid profile testing.

Secondary

MeasureTime frame
Secondary effects:1-Percentage of acute coronary syndrome (ACS: Unstable angina, NSTEMI, STEMI)2- Percentage of incidence of metabolic syndrome (by examining each metabolic syndrome criteria: abdominal circumference, fasting blood sugar level, HDL level, TG level, blood pressure level) in future monthly visits3. The percentage of LDL serum levels of patients after the study. Timepoint: Before starting the study, 30 days later and then 60 days after taking the capsules. Method of measurement: Description of oral condition in the form of an interview for the occurrence of ACS - use of sphygmomanometer to measure blood pressure - use of routine lipid profile tests and fasting blood sugar.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactBahman Khameneh Bagheri

Mashhad University of Medical Sciences

Khamenehbagherib@mums.ac.ir+98 51 3864 5427

Outcome results

None listed

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