TABLE 4.

Criteria Check-list Suggested for Future Probiotic Clinical Trial Studies.

Design
[ ]	Double-blind, placebo controlled if possible
[ ]	Cross-over design with subjects serving as their own controls
[ ]	Use of drugs, alcohol, and other influencing factors controlled
[ ]	At least 1-week duration for treatment
[ ]	At least 4-week washout period before and after treatment or control
Subjects
[ ]	At least 10 per group
[ ]	Subjects age between 18–64 years
[ ]	No ethnic group variation
[ ]	Exclusion criteria Lactase deficiency No illness or disease present History of gastrointestinal, hepatic, or renal disease Obesity (BMI > 30 kg/m2) Subjects taking medication that could affect either the intestinal flora and/or the immune system and hematological and biochemical parameters Unwilling to eliminate fermented foods/beverages Women who are pregnant, suspect they are pregnant, or are lactating unwilling/unable due to physicians orders to be prescription free during study Internal infection during the study Any use of antibiotics or sulfonamides during the study
Treatment
[ ]	Natural probiotic (food/beverage) source
[ ]	If supplement used, state how much higher than probiotic food source
[ ]	Diet eliminates other fermented foods—Soy sauce, miso, sausage (salami, bologna, etc), yogurt, buttermilk, acidophilus milk, kefir, sour cream, cheese, kimchee, sauerkraut, green olives, pickles, tempeh, or other foods/beverages
[ ]	Alcohol intake recorded
Measurable Outcomes
[ ]	Total bacterial count (log10 CFU/g)
[ ]	Species specific (log10 CFU/g)
[ ]	Fecal enzyme activity—beta-glucuronidase, nitroreductase, azoreductase, 7-alpha-dehydroxylase, etc.
[ ]	Breath hydrogen
[ ]	Fecal pH
[ ]	Immune system—immunoglobulins, interferon, etc.
[ ]	Gastrointestinal symptoms—bloating, cramping, discomfort,
[ ]	Stool frequency/consistency
[ ]	Quality of life questionnaire