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Effects of prebiotic in Heart-Gut axis of heart failure patients.

Role of Prebiotics Supplementation on Heart Failure with Reduced Ejection Fraction (HRrEF) and Itâ??s Modulatory Effect on Heart Gut Axis - Not Applicable

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2023/02/050088
Enrollment
45
Registered
2023-02-26
Start date
Unknown
Completion date
Unknown
Last updated
2023-03-06

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

Conditions

Health Condition 1: I509- Heart failure, unspecified

Interventions

Intervention1: Corn Starch will be given as oral intervention: dosage of 10gms per day for 90 days Control Intervention1: Not Applicable: Not Applicable

Sponsors

Narayana Hrudayalaya
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: • Age: 18-60 years • Have a heart failure in New York Heart Association class II and class III and class IV • Echocardiographically verified LVEF • Signed informed consent and expected cooperation of the patients for the treatment

Exclusion criteria

Exclusion criteria: • Treatment with antibiotics or probiotics within the last 3 months • Treatment with immunosuppression drugs within the last 3 months • History of high fibre in toleration • Malignancy of any cause, excluding basal cell sarcoma of the skin • Severely impaired kidney function (i.e., Estimated glomerular filtration rate • Impaired liver function (Alanine aminotransferase > 150 U/I) or Chronic liver disease • Ongoing Infection, including GI infection • Inflammatory Bowel Disease • Bowel obstruction • Post Colectomy • Active myocarditis, including Chagas disease • Pregnancy and planned pregnancy • Lactation

Design outcomes

Primary

MeasureTime frame
Outcomes to be measured- potential prebiotic supplementation effects on gut microbiota The effect will be measured by correlating with gut microbiome profile, changes in biochemical parameters and correlating it with dietary questionnaire.Timepoint: 12 MONTHS

Secondary

MeasureTime frame
1.The impact of prebiotics supplementation on cardiac left ventricular hypertrophy on heart failure with reduced ejection fraction (HfrEF)-Measured by analyzing changes in ECCO reports 2.The potential prebiotic supplementation effects on inflammatory stress indices, and liver function in individuals with heart failure with reduced ejection fraction- Based on changes in biological parameters 3.whether prebiotic supplementation will improve quality of life in individuals with heart failure with reduced ejection fraction (HfrEF)- Based on responses obtained from study participantsTimepoint: 12 MONTHS to 36 months

Countries

India

Contacts

Public ContactDr Muralidhar K

Sri Devaraj Urs academy of higher Education and research

nutrition@sduaher.ac.in9972307909

Outcome results

None listed

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