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The effect of synbiotic use on heart failure

The effect of synbiotic consumption on serum paraoxonase 1(PON1), Soluble CD163/Soluble TNF-like weak inducer of apoptosis(sCD163/sTWEAK) and lipid profile in patients with chronic heart failure

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20091114002709N55
Enrollment
90
Registered
2020-11-04
Start date
2020-08-13
Completion date
Unknown
Last updated
2020-11-30

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

Conditions

Chronic heart failure. Cardiac, heart or myocardial failure NOS

Interventions

Intervention 1: Intervention group: Patients will be given 1 capsule of lactocare synbiotic daily for 10 weeks. Lactocare Synbiotic Capsules are manufactured by Zist Takhmir Company .Lactocare is an o

Sponsors

Iran University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
30 Years to 70 Years

Inclusion criteria

Inclusion criteria: Age range from 30 to 70 yearsPatients with systolic heart failure (LVEF <40%) approved by a cardiologist and receiving at least 3 months of standard heart failure treatment , Medications have reached the maximum tolerated dose and their medication dose will remain constant throughout the study.class 1,2 and 3 of NYHA classificationWillingness to participate in the study and sign informed written consentLack of other diseases including chronic and acute liver disorders (hepatitis B, C, etc.), diabetes, thyroid disorders, severe renal dysfunction (300 mmol /l = creatinine ), pulmonary diseases, inflammatory and autoimmune diseases, Cancer, acute infectionNot using any nutritional supplements for the past two months.No substance abuse and smokingNot taking Corticosteroids in the past 4 weeksFailure to receive antibiotics in the past 3 monthsNo history of gastrointestinal surgeryNo anti-inflammatory drugs except low-dose aspirin (one 80 mg daily)No artificial heart valveNo history of rheumatic heart diseaseNot being pregnant and breastfeedingLack of insulin BMI< 30

Exclusion criteria

Exclusion criteria: Not willing to continue cooperationuse of less than 80% of supplements given to the patient during the study period Acceptance rate = The number of capsules given to the patient - the Number of capsules not used / The number of capsules given to the patientother disease such as metabolic diseases,Cancer and inflammatory diseases during the study that Need special treatment or antibiotic use.Changes in the type and dose of drug which is using by the patient .

Design outcomes

Primary

MeasureTime frame
SCD163 to sTWEAK ration. Timepoint: Before intervention and 10 weeks after the start of intervention. Method of measurement: ELISA kit.

Secondary

MeasureTime frame
Paraoxonase 1. Timepoint: Before intervention and 10 weeks after the start of intervention. Method of measurement: ELISA kit.;Triglyceride. Timepoint: Before intervention and 10 weeks after the start of intervention. Method of measurement: colorimetri.;Total cholestrol. Timepoint: Before intervention and 10 weeks after the start of intervention. Method of measurement: colorimetri.;LDL-c. Timepoint: Before intervention and 10 weeks after the start of intervention. Method of measurement: colorimetri.;HDL-C. Timepoint: Before intervention and 10 weeks after the start of intervention. Method of measurement: colorimetri.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr.Farzad Shidfar

Iran University of Medical Sciences

Shidfar.f@iums.ac.ir+98 21 8862 2755

Outcome results

None listed

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