NCT04743726

Research on the Physiological Characteristics of the Gastrointestinal Tract in Chinese Volunteers

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 24 (estimated)
• Sponsor: Dongyang Liu · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

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 enzymes/transports 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.

Conditions

• Endoscopy, Gastrointestinal

Timeline

• Start date: 2020-10-31
• Primary completion: 2022-09-01
• Completion: 2022-09-01
• First posted: 2021-02-08
• Last updated: 2021-02-08

Locations

1 site across 1 country: China