To study the effect of Probiotics Bacillus subtilis on Diarrhoea due to antibiotics

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

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2018/01/011186

Enrollment

Registered

2018-01-08

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- Patients having taken antibiotics within four weeks prior to enrollment

Interventions

Intervention1: Probiotic Bacillus subtilis HU58 Capsules: Each capsule to be given once a day orally after food for 7 days Control Intervention1: Placebo Capsules: Each capsule identical to Probiotic

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

Measure	Time frame
To evaluate the role of Probiotic- Bacillus subtilis HU58 in Antibiotic associated Diarrhoea in Humans in comparison to placeboTimepoint: 15 days	—

Secondary

Measure	Time frame
Safety and tolerability; clinical variablesTimepoint: 15 days	—

Countries

India

Contacts

Public ContactDr Shashank Jadhav

Synergia Life Sciences Pvt. Ltd.

yogesh_dound@yahoo.com022-24055607

Outcome results

None listed

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