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The study to explore the effect of Bacillus calusii and Bacillus Coagulans (the Probiotics) on Covid-19 disease progression in addition to routine Covid-19 treatment.

Safety and Efficacy of Bacillus clausii and Bacillus coagulans Spores as Add on to Standard Therapy to Study the Progress of SARS-CoV-2 Infection in Patients with Moderate Symptoms of COVID-19 - A Randomized, Double Blind, Placebo Control, Three Arm Parallel Group Study.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2021/03/031720
Enrollment
90
Registered
2021-03-04
Start date
Unknown
Completion date
Unknown
Last updated
2022-10-17

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

Conditions

Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere

Interventions

Intervention1: Bacillus clausii 2 billion Spores: orally administered, after food, morning and evening 2 times a day, for 14 days. Intervention2: Bacillus coagulans 2 billion spores: orally administer

Sponsors

Dr Mehdi Ali Mirza
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Patients of either gender, diagnosed to be COVID-19 positive through RTPCR method. 2. Patients presenting with moderate symptoms. 3. Patients of age more than 18 years. 4. Willing to comply with study related procedures.

Exclusion criteria

Exclusion criteria: 1. Known history of hypersensitivity or allergy to probiotics 2. Pregnant or lactating woman 3. Patients with mild and severe infections, critically ill patients. 4. HIV or HBsAg positive

Design outcomes

Primary

MeasureTime frame
1. Time to Clinical recovery after hospitalization 2. Improvement in inflammatory, immune and clinical parameters 3. Proportion of patients recovering in each group Timepoint: Clinical parameter- day1 to day 14 laboratory parameters- day 1,3,7,14 respectively.—

Secondary

MeasureTime frame
1. Proportion of patients Step-up in each group 2. Proportion of patient Step-down in each group 3. Number and type of adverse events in each group 4. Proportion of patients developing gastroenteritis in each group Timepoint: Clinical parameters- day 1 to 14 laboratory parameters on day 1, 3, 7, 14 respectively.—

Countries

India

Contacts

Public ContactDr Mehdi Ali Mirza

ESIC Medical College and Hospital

drrajivb85@gmail.com9885633040

Outcome results

None listed

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