Tendency toward constipation
Conditions
Interventions
Ingestion of peptide for 4 weeks.
Ingestion of placebo for 4 weeks.
Sponsors
CROee.INC
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1)Japanese male and female ages 20-64 years old (inclusive) (2)Subjects with tendency for constipation at 3 to 5 times of defecation per week (3)Subjects who take 3 meals per day regularly (4)Willing and able to provide signed written informed consent
Exclusion criteria
Exclusion criteria: 1)Subjects with severe hepatic, renal, cardiac, pulmonary, gastrointestinal, hematologic, endocrine and metabolic diseases / disorders 2)Subjects who suffer from diseases/ disorders with continuous medical treatment or with medical history of severe diseases/ disorders needed medical treatment 3)Subjects who suffer from diseases/ disorders that affects the study and are receiving medical treatment from medical institution or have surgical history of digestive system ( except appendectomy) 4)Subjects who suffer from diseases/ disorders that affects bowel movement such as irritable bowel syndrome or ulcerative colitis etc or have medical history of above-mentioned diseases/ disorders 5)Subjects with history of sensitivity to the ingredients 6)Pregnant, lactating women or willing to be pregnancy during the study 7)Subjects who take any kind of medicine ( laxative, intestinal drug etc) that possibly affect bowel movement 8)Subjects who take supplements and/or functional foods (including Food for Specified Health Uses [FOSHU]) regularly that possibly affect bowel movement 9)Subjects who have a habit of eating lactic fermenting beverage or food or Lactobacillus preparation that contain many lactobacillus, food fortified with dietary fiber and/or oligosaccharide 3 and more times per week 10)Any candidate considered to be unsuitable for enrollment based on his/her answers of life style questionnaire 11)Subjects who had participated in other clinical trials including drug and food within 1 month. 12)Any candidate considered to be unsuitable for enrollment in the opinion of the principal investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Intestinal flora analysis | — |
Secondary
| Measure | Time frame |
|---|---|
| Defecation frequency Defecation days Questionnaire on sleeping quality (OSA inventory-MA version ) | — |
Countries
Japan
Contacts
Public ContactShigeru Imai
CROee.INC Evidence Division
Outcome results
None listed