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

Phase 4

Active, not recruiting

• Conditions: Patients having taken antibiotics within four weeks prior to enrollment

• Registration Number: CTRI/2018/01/011186
• Lead Sponsor: Synergia Life Sciences Pvt Ltd

Brief Summary

The current study is formulated in order to evaluate the effect of supplementation of *Bacillus subtilis* HU58 Probiotics on Antibiotic associated Diarrhea in humans in comparison with placebo.

N = 60

Detailed Description

Not available

Study Timeline

• Study Start: 2018-01-22
• Last Update Posted: 2021-04-30

Recruitment & Eligibility

• Status: Closed to Recruitment of Participants
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

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

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To evaluate the role of Probiotic- Bacillus subtilis HU58 in Antibiotic associated Diarrhoea in Humans in comparison to placebo	15 days

Secondary Outcome Measures

Name	Time	Method
Safety and tolerability; clinical variables	15 days

Trial Locations

Locations (1)

Kokan Hospital; 🇮🇳 Mumbai, MAHARASHTRA, India

Kokan Hospital

🇮🇳Mumbai, MAHARASHTRA, India

Dr Milind Devale

Principal investigator

022-28374646

milinddevale75@gmail.com