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To study the effect of Probiotics Bacillus subtilis HU58 and Bacillus coagulans SC209 on Diarrhoea due to antibiotics

An Open Labeled, Placebo Controlled Trial to Evaluate Role of Probiotic- Bacillus subtilis HU58 and Bacillus coagulans SC208 on Antibiotic associated Diarrhoea in Humans

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2018/06/014439
Enrollment
75
Registered
2018-06-06
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: K928- Other specified diseases of the digestive system Health Condition 2: null- Patients having taken antibiotics within four weeks prior to enrollment

Interventions

Intervention1: Probiotic Bacillus coagulans SC208 Capsules: Each capsule to be given once a day orally after food for 7 days Intervention2: Probiotic Bacillus subtilis HU58 and Bacillus coagulans SC20

Sponsors

Synergia Life Sciences Pvt Ltd
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1.Male and female aged 18 to 65. 2.Stable ECG. 3.Willing to give informed consent

Exclusion criteria

Exclusion criteria: 1.Sero positive patients. 2.Pregnancy. 3.Subjects who are on other Probiotics or prebiotics. 4.Subjects who are addicted to tobacco, alcohol. 5.Subjects who are on any other medication than prescribed oral antibiotics.

Design outcomes

Primary

MeasureTime frame
To evaluate the role of Probiotic- Bacillus subtilis HU58 and Bacillus coagulans SC208 in Antibiotic associated Diarrhoea in Humans in comparison to placeboTimepoint: 15 days

Secondary

MeasureTime frame
Safety and tolerability; clinical variablesTimepoint: 15 days

Countries

India

Contacts

Public ContactDr Shashank Jadhav

Synergia Life Sciences Pvt Ltd

yogesh_dound@yahoo.com02224055607

Outcome results

None listed

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