Ignite Creation Date:
2024-05-06 @ 3:46 PM
Last Modification Date:
2024-10-26 @ 1:56 PM
Study NCT ID:
NCT04743726
Status:
UNKNOWN
Last Update Posted:
2021-02-08
First Post:
2021-01-27
Brief Title:
Research on the Physiological Characteristics of the Gastrointestinal Tract in Chinese Volunteers
Sponsor:
Dongyang Liu
Organization:
Peking University Third Hospital
Study Overview
Official Title:
Research on the Physiological Characteristics of the Gastrointestinal Tract in Chinese Volunteers
Status:
UNKNOWN
Status Verified Date:
2021-02
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The dissolution and absorption of oral drugs in the gastrointestinal tract is a complex process which is affected by physiological factors such as transporters metabolic enzymes gene phenotypes gastrointestinal diseases intestinal flora and so on Therefore the investigators are planning to collect gastrointestinal mucosa tissues gastric juice saliva feces and blood samples to investigate 1 the activity and abundance of metabolism enzymestransports in different section of gastrointestinal tract 2 the composition and physicochemical properties of gastric juice 3 the distribution and abundance of bacterial in gastrointestinal mucosa saliva gastric juice and feces 4 the composition and content of bile acid in gastrointestinal mucosa gastric juice and plasma in Chinese volunteers who planning to undergo digestive endoscopy
Detailed Description:
This is a single-center open-labelled study Twenty four Chinese adult volunteers who schedule for gastrointestinal endoscopy will be enrolled and will be not allowed to take products containing grapefruit fruit juice tea coffee wine and other foods or drinks containing caffeine xanthine and alcohols at least 14 days before the gastrointestinal endoscopes In addition smoking is also prohibited Screen will be performed any day between 3 and 14 days prior to the gastrointestinal endoscopes Feces saliva and 4 ml whole blood samples will be collected from these participants 3 days before gastrointestinal endoscopes for the detection of bacterial diversity metabolic enzymes transporter-related genotypes and bile acids Afterwards participants will undergo painless gastroscopy Meanwhile gastric juice mucosal tissue from stomach duodenum jejunum ileum colon will be collected The total number of mucosal tissue no more than 10
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None