Tokyo, Oct. 1 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000063073) titled 'A study on the Effects of Lactosucrose Intake on BowelMovements and PhysicalCondition' on Oct. 1.
Study Type:
Interventional
Study Design:
Basic Design - Parallel
Randomization - Non-randomized
Blinding - Double blind -all involved are blinded
Control - Placebo
Primary Sponsor:
Institute - Others
Condition:
Condition - Adult male and female
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - Investigating changes in bowel movements and gut microbiota and physical condition following 8weeks of lactosucrose intake
Basic objectives2 - Efficacy
Intervention:
Interventions/Control_1 - The test food (lactosucrose syrup) will be consumed at 8grams per day for 8 weeks
Interventions/Control_2 - The placebo food (mizuame) will be consumed at 8grams per day for 8 weeks
Eligibility:
Age-lower limit - 60
years-old
<=
Age-upper limit - Not applicable
Gender - Male and Female
Key inclusion criteria - 1.Persons who are 60years old or older
2.Subjects diagnosed with chronic constipation and currently using laxatives
3.Individuals who are able to provide written informed consent to participate in the study,
either personally or through a legal representative, after being informed of the study's purpose and details
Key exclusion criteria - 1.Those who are parenteral nutrition management
2.Subjects who showed abnormal abdominal symptoms following intake of the test food
3.Subjects judged to be inappropriate for participation in the study by the principal investigator or a physician involved in the research
Target Size - 50
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2026 Year 08 Month 06 Day
Date of IRB - 2026 Year 08 Month 06 Day
Anticipated trial start date - 2026 Year 10 Month 01 Day
Last follow-up date - 2030 Year 03 Month 31 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067950
Disclaimer: Curated by HT Syndication.
