CTRI/2018/06/014439Active, not recruitingPhase 4
An Open Labeled, Placebo Controlled Trial to Evaluate Role of Probiotic- Bacillus subtilis HU58 and Bacillus coagulans SC208 on Antibiotic associated Diarrhoea in Humans
Synergia Life Sciences Pvt Ltd1 site in 1 country75 target enrollmentStarted: June 18, 2018Last updated:
Conditions
Trial Snapshot
- Phase
- Phase 4
- Status
- Active, not recruiting
- Enrollment
- 75
- Locations
- 1
- Primary Endpoint
- To evaluate the role of Probiotic- Bacillus subtilis HU58 and Bacillus coagulans SC208 in Antibiotic associated Diarrhoea in Humans in comparison to placebo
Study Overview
Brief Summary
The current study is formulated in order to evaluate the effect of supplementation of Probiotic Bacillus subtilis HU58 and Bacillus coagulans SC209 on Antibiotic associated Diarrhea in humans in comparison with placebo.
N = 75
Study Design
- Study Type
- Interventional
- Allocation
- Not Applicable
- Masking
- Open Label
Eligibility Criteria
- Ages
- 18.00 Year(s) to 65.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •1.Male and female aged 18 to
- •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.
Outcomes
Primary Outcomes
To evaluate the role of Probiotic- Bacillus subtilis HU58 and Bacillus coagulans SC208 in Antibiotic associated Diarrhoea in Humans in comparison to placebo
Time Frame: 15 days
Secondary Outcomes
- Safety and tolerability; clinical variables(15 days)
Investigators
Study Sites (1)
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