Effects of consumption of the test food on the bowel movement in healthy Japanese subjects

Authors
Category Primary study
Registry of TrialsUMIN Clinical Trials Registry
Year 2024
INTERVENTION: Duration: Two weeks Test food: Food containing lactic acid bacteria Administration: Take one packet with water once daily *If you forget to take the test food, take it as soon as you remember. Daily dose should be taken within the day and not carried over to the next day. Duration: Two weeks Test food: Placebo food Administration: Take one packet with water once daily *If you forget to take the test food, take it as soon as you remember. Daily dose should be taken within the day and not carried over to the next day. CONDITION: Healthy Japanese subjects PRIMARY OUTCOME: 1. The defecation frequency in period III* *Period III: The 2nd week after consumption of the test food SECONDARY OUTCOME: 1. The defecation frequency in period II* 2. The numbers of defecation days and amount of defecation in period II and III* 3. The rate of each state for stool shape, stool smell, and exhilarating feeling of defecation in period II and III* 4. The score of the Japanese Version of the Constipation Assessment Scale [middle term] (CAS‐MT) at two weeks after consumption (2w) 5. Each item of CAS‐MT at 2w 6. The intestinal flora at 2w 7. Each item of an original questionnaire at 2w * Period I: Seven days prior to screening (before consumption: Scr) Period II: The 1st week after consumption of the test food Period III: The 2nd week after consumption of the test food INCLUSION CRITERIA:
Epistemonikos ID: d75d71abf134b9a27c825595d0c49bca67b29462
First added on: Aug 28, 2024