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Table 2 Schedule of events

From: Bacillus coagulans MTCC 5856 supplementation in the management of diarrhea predominant Irritable Bowel Syndrome: a double blind randomized placebo controlled pilot clinical study

Procedures Screening Visit 1 Visit 2 Visit 3 Visit 4 Follow up
(Day 0) Baseline (Day 30) (Day 60) (Day 90) Final visit (Atleast 15 days from last visit)
Informed consent X      
Medical history X      
Physical examination X X X X X  
Demographicsa   X X X X  
Vital signsb X X X X X  
Hematology X     X  
Serum chemistry X     X  
Stool test for consistency X     X  
Urine pregnancy testc X      
Randomization   X     
IP dispensing and dosing   X X X   
VAS assessment   X X X X  
Gastrointestinal discomfort questionnaire   X X X X  
Bristol stool score   X X X X  
Physician’s global assessment   X X X   
Irritable bowel syndrome (IBS) quality of life questionnaire   X X X X  
Adverse events (AEs)   X X X X X
Concomitant medications   X X X X X
  1. aAge, gender, height, weight and BMI
  2. bVitals – pulse, temperature, blood pressure, heart rate, respiratory rate
  3. cUrine pregnancy test at screening and on early termination