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Table 2 Visit schedule

From: The effects of the DDS-1 strain of lactobacillus on symptomatic relief for lactose intolerance - a randomized, double-blind, placebo-controlled, crossover clinical trial

Protocol Activity V1 (Screening) V1.5 (Screening) Washout period V2 (Arm 1) V3 (Arm 1) V4 (Arm 1) Washout period V5 (Arm 2) V6 (Arm 2) V7 (Arm 2)
  Week (−2)    Week 0 Week 2 Week 4   Week 0 Week 2 Week 4
Informed consent process x          
Inclusion/Exclusion x          
Medical history & physical exam x          
Vital signs x x   x x x   x x x
Urine pregnancy test x          
Standardized meals x x   x x x   x x  
Administer & review scales and questionnaires     x x x   x x x
Review concomitant therapies   x   x x x   x x x
Intercurrent medical issues review   x   x x x   x x x
Randomization/study product preparation & dispensing     x x    x x  
Hydrogen breath test   x   x x x   x x x
Fecal collection     x x x   x x x