Tokyo, Dec. 20 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000060129) titled 'Study on the Dose of Oligosaccharide That Affects the Gut Microbiota' on Dec. 19.
Study Type:
Interventional
Study Design:
Basic Design - Single arm
Randomization - Non-randomized
Blinding - Open -no one is blinded
Control - Uncontrolled
Primary Sponsor:
Institute - Meiji Holdings Co., Ltd.
Condition:
Condition - Healthy adults
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - To examine the effect on gut microbiota by administration of oligosaccharide 1g for 2 weeks.
Basic objectives2 - Efficacy
Intervention:
Interventions/Control_1 - Oral ingestion of oligosaccharide for 2 weeks
Eligibility:
Age-lower limit - Not applicable
Age-upper limit - Not applicable
Gender - Male and Female
Key inclusion criteria - 1 Those who participated in the in-house monitoring program
2 Those whose workplace is the Meiji Innovation Center on the date of consent
3 Those who have received sufficient explanation about the purpose and content of this study,have the ability to consent,fully volunteered with voluntary intention,agreed to participate
Key exclusion criteria - 1 Those who have participated in a study involving another intervention during the month prior to screening or who plan to participate in a study involving another intervention during the period between screening and the end of the intake period
2 Those who have a history of gastric or lower gastrointestinal tract surgery excluding hemorrhoids
3 Those who have a barium stomach X-ray, small or large intestine endoscopy, or bowel cleansing at a clinic or at home during the month prior to screening, or those who are scheduled to have these procedures during this study
4 Who have taken, ingested, or used drugs that may affect the study at least once a week during the month prior to screening, or who plan to take, ingest, or use these drugs at least once during the study
5 Those who plan to travel abroad, travel for more than one week, or go on a business trip during the period from one week prior to the intake period to the end of the intake period
6 Those who have food allergies
7 Those who are pregnant or breastfeeding
8. Subjects judged as unsuitable for the study by the principal investigator or research physician for other reasons
Target Size - 30
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2025 Year 12 Month 15 Day
Date of IRB - 2025 Year 12 Month 11 Day
Anticipated trial start date - 2025 Year 12 Month 22 Day
Last follow-up date - 2026 Year 02 Month 22 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068769
Disclaimer: Curated by HT Syndication.