can probiotics reduce the inflammation in acute coronary syndrome patients

Effect of probiotics on level of inflammatory markers in patients of acute coronary syndrome - EPIC

Status

Active, not recruiting

Phases

Phase 3Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2017/06/008802

Enrollment

312

Registered

2017-06-09

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

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

Conditions

Health Condition 1: null- ACUTE CORONARY SYNDROME

Interventions

Intervention1: VSL#3, CONTAINING LACTIC ACID BACTERIA AND BIFIDOBACTERIA OR ITS DERIVATIVES AS MENTIONED IN CAPSULES AT STRENGTH OF 112.5 BILLION CFU PER UNIT DOSAGE FORM, ROUTE OF ADMINISTRATION-OR

DOSE- ONE UNIT PER DAY. DURATION OF INTERVENTION- 18 MONTHS FROM FIRST DOSE.: streptococcus thermophilus DSM 24731

bifidobacteria infantis DSM 24737

bifidobacteria longum DSM 24736

bifidobacteria breve DSM 24732

lactobacillus acidophilus DSM 24735

lactobacillus plantarum DSM 24730

lactobacillus paracasei DSM 24733

lactobacillus.delbrueckii subsp.bulgaricus

DSM 24734

Control Intervention1: placebo: PLACEBO CONTAINS MALTOSE, ROUTE OF ADMINISTRATION -ORAL, DOSE: ONE UNIT PER DAY

DURATION: 18 MONTHS FROM THE FIRST DOSE. Control Intervention2: comparator will be containing maltose in a similar looking form as VSL#3: maltose, given as single unit dose after meals(lunch), through

Eligibility

Inclusion criteria

Inclusion criteria: PATIENTS WITH ACUTE CORONARY SYNDROME

Exclusion criteria

Exclusion criteria: Acute coronary syndrome patients who also will have the following conditions 1.Atrial flutter, 2.Atrial fibrillation, 3.Bundle branch block(BBB) 4.Dilated cardiomyopathy 5.Valvular heart disease 6.Malignancy 7.Chronic inflammatory conditions like a)Systemic lupus erythmatosis b)Rheumatoid Arthritis c)Ulcerative colitis d)Ankylosing spondylitis and others affecting the study markers.

Design outcomes

Primary

Measure	Time frame
change in the serum levels of inflammatory markers -hsCRP TNF- alpha,IL-10Timepoint: AT THE END OF 18 MONTHS OF INTERVENTION WITH PROBIOTICS(VSL#3) IN EACH PARTICIPANT.	—

Secondary

Measure	Time frame
QUALITY OF LIFE AND FUTURE CARDIAC EVENTSTimepoint: 18 MONTHS from the day of recruitment	—

Countries

India

Contacts

Public ContactDr Deepa S Sajjannar

BLDEU SBMP Medical College Hospital and Research Center

registrar@bldeuniversity.ac.in9845292623

Outcome results

None listed

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