NIPH Clinical Trials Search

Synergy effect when probiotics and prebiotics eaten together

Basic Information

Recruitment status	Complete: follow-up complete
Health condition(s) or Problem(s) studied	Constipation and intestinal dysbiosis
Date of first enrollment	2016/12/04
Target sample size	28
Countries of recruitment	Japan
Study type	Interventional
Intervention(s)	intake of test food containing Bifidobacterium lactis HN019 1 billion, CFU/3.33mg, daily with 100ml water or milk for 2 weeks intake of test food containing6.25g polydextrose daily with 100ml water or milk for 2 weeks intake of test food containing Bifidobacterium lactis HN019 1 billion, CFU/3.33mg, daily and 6.25g polydextrose daily with 100ml water or milk for 2 weeks intake of placebo food containing 6.25g dextrin daily with 100ml water or milk for 2 weeks

Outcome(s)

Primary Outcome	change in stool frequency and intestinal microbiota after supplementation of test foods for 2 weeks
Secondary Outcome	questionnaire survey about eating behavior and psychosomatic state

Key inclusion & exclusion criteria

Age minimum	18years-old
Age maximum	Not applicable
Gender	Female
Include criteria
Exclude criteria	1) has history of cardiovascular diseases, liver disease, kidney disease digestive tract disease, respiratory disease, diabetes 2) has history of malignant disease or now on chronic disease therapy 3) takes drugs to treat disease 4) has history of drug and food allergy 5) has continuous intake of dietary fiber supplement (dietary fiber rich foods made with seaweed, konjak, psyllium etc) or whole grain cereals(whole grain wheat, brown rice, barley) 6) Females who are pregnant or lactating, and who could become pregnant during test period. 7) has smoking habit 8) Subjects who are participating the other clinical tests. Subjects who participated within 1-month prior to the current study and/or who plan to participate the other clinical tests. 9) has history of drug addiction or in therapy for drug addiction 10) Subject whose stool frequency is more than 5 days weekly 11) is not appropriate in the investigator's opinion