CTRI/2010/091/000142CompletedPhase 2
An Open Label, III Arm, Comparative, Randomized, Phase II Clinical Trial Of Probiotic Strains Saccharomyces Boulardii, Bacillus Coagulans And Bacillus Clausii In The Treatment Of Patients With Acute Diarrhea
nique Biotech Limited0 sites75 target enrollmentStarted: TBDLast updated:
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Enrollment
- 75
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
Inclusion Criteria
- •1.Adults with acute diarrhoea having > 3 loose stools in last 24 hours, having diarrhoea < 7 Days.
- •2.Patients with no major illness.
- •3.Patients willing to give written informed Consent & willing to follow up.
Exclusion Criteria
- •1.Mucous stools or bleeding per rectum
- •2.Subjects taking any other medications like anticoagulants, beta-blockers, diuretics, and steroids etc., which have potential effects on lipoprotein regulation mechanisms.
- •3.Subjects with the recent history of cardiovascular diseases like MI or who have undergone angioplasties, coronary bypass surgery or any other documented morbidity from atherosclerotic vascular diseases within the last 6 months of enrollment.
- •4.Subjects with past history of any debilitating neurological disorders, severe depression.
- •5.Clinical signs of severe dehydration, clinical signs of coexisting acute systemic illnesses (meningitis, sepsis, pneumonia), immunodeficiency, underlying severe chronic diseases, cystic fibrosis,
- •6.Food allergy or other chronic gastrointestinal diseases,
- •7.Use of probiotics in the previous three weeks, use of antibiotics or any antidiarrhoeal medication in the previous three weeks.
Investigators
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