Endoscopy, GastrointestinalNCT04743726
Research on the Physiological Characteristics of the Gastrointestinal Tract in Chinese Volunteers
An observational study of Endoscopy, Gastrointestinal, run by Dongyang Liu at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Endoscopy, Gastrointestinal
- How many people
- 24 participants
- Where
- 1 siteChina
- Study dates
- 31 Oct 2020to Sep 2022
- How long will I take part?
- 18 Days
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Chinese volunteers who are planning to undergo gastrointestinal endoscopy
Who may be able to join
- Chinese volunteers who are planning to undergo digestive endoscopy;
- Volunteers who have a full understanding of the content, process and possible adverse reactions of the study and have signed an informed consent form before the clinical trial;
- Volunteers who are able to complete the clinical trial according to the protocol;
- Male and female volunteers between the ages of 18 and 60 (including both ends) on the date of signing the consent form;
- Female volunteers are non-pregnant or non-lactating women, and will live asexually after enrollment until the end of the trial;
- Male volunteers weigh no less than 50 kg, female volunteers weigh no less than 45 kg, and the body mass index (BMI) of male and female volunteers within the range of 19.0-26.0 kg/m2 (including cut-off values);
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- The comprehensive physical examination, routine laboratory examinations are normal or abnormal, but the investigator judges that there is no clinical significance;
- Volunteers who are able to abstain from alcohol, coffee, non-prescription drugs or prescription drugs, and no food and beverages related to grapefruit within 14 days before the start of the test until the end of the test;
- Volunteers have no history of smoking
Who cannot join
- Volunteers who disagree with "No food or beverages containing caffeine, xanthine and alcohols such as grapefruit-containing products, juice, tea, coffee, wine, etc., 14 days before endoscope", "No smoking 14 days before endoscope";
- Volunteers who do not comply with the relevant regulations about endoscope;
- Volunteers with endoscope contraindications;
- Volunteers with HCV, HIV, HBsAg and/or syphilis positive antibody;
- Volunteers with allergic physique;
- Volunteers with needlesickness, blood phobia, difficult in collecting blood and in tolerating local anesthesia;
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- Females who are pregnant, breastfeeding, or taking birth control pills for less than 3 months;
- Volunteers have bleeding disorders, or therapeutic anticoagulation (warfarin, aspirin, clopidogrel, traditional Chinese medicine, etc.), or anesthesia dependence or alcohol dependence;
- Volunteers have the smoking history, alcoholism history, alcohol screening positive, drug screening positive, history of drug abuse in the past five years or administration drugs in the three months prior to the trial;
- Alcoholics (14 units of alcohol consumed per week: 1 unit = 285 mL beer, or 25 mL spirits, or 100 mL wine) and volunteers who cannot prohibition from the time of enrollment to the end of the study;
- Volunteers who have a history of gastrointestinal disease with a definite severity or have diseases that have been considered unsuitable for participating in this study by researchers;
- Volunteers with obvious gastrointestinal discomfort within 6 months before the start of the clinical trial;
- Volunteers who have undergone gastrointestinal and liver surgery and those who have received any other surgery 6 months before the clinical trial;
- The clinical laboratory examination is abnormal and the researchers judges that it has clinical significance;
- Volunteers who have taken any clinical trial drugs within 3 months;
- Volunteers who have used any antibiotics within 3 months;
- Volunteers who have used any drug within 1 month;
- Volunteers with hypertension （systolic blood pressure>139 mmHg，diastolic blood pressure>89 mmHg);
- Volunteers with Parkinson's disease or family history of Parkinson's disease;
- Volunteers with a family history of sudden cardiac death or arrhythmia;
- Habitual drink, including coffee, tea, grapefruit juice and so on;
- Significant weight loss recently;
- Researcher judge that the volunteer has other factors that are not suitable for participating in this study, regardless of their severity
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Endoscopy | Chinese volunteers who are scheduling for gastro-colonoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
The activity and abundance of metabolism enzymes/transports in different section of gastrointestinal tract
LC-MS / MS will be used to quantitatively determine the activity of enzymes/transporters and protein content in mucosal samples including CYP1A2, CYP2C9, CYP2C19, CYP2D6, CYP2E1, CYP2J2, CYP3A4, CYP3A5, UGT1A1, UGT1A3, UGT1A4, UGT1A6, UGT1A7, UGT1A8, UGT1A10, UGT2B7, UGT2B17, ABCB1, ABCC2, ABCC3, ABCG2, ASBT, CNT1, CNT2, SGLT1, OATP2B1, OCTN1, OCIN2, OCT1, OCT3, PEPT1.
Measured: Feb,2021-Sep, 2022
The physicochemical properties of gastric juice
The physicochemical properties of gastric juice including pH, viscosity, buffer capacity, osmotic pressure, and so on will be determined by means of pH-meter, rheometer, burette, freezing point depression, and so on
Measured: Feb,2021-Sep, 2022
The composition of gastric juice
The composition of protein in gastric juice will be measured by LC-MS/MS or HPLC
Measured: Feb,2021-Sep, 2022
The composition and content of bile acid in gastrointestinal mucosa, gastric juice and plasma
LC-MS/MS or HPLC will be used to determine the composition of bile acids in mucosal tissues, gastric juice and blood
Measured: Feb,2021-Sep, 2022
The distribution of bacterial in gastrointestinal mucosa, saliva, gastric juice and feces
The distribution of bacteria in mucosa samples and gastric juice will be determined by high-throughput sequencing
Measured: Feb,2021-Sep, 2022
The abundance of bacterial in gastrointestinal mucosa, saliva, gastric juice and feces
The abundance of bacteria in mucosa samples and gastric juice will be determined by high-throughput sequencing
Measured: Feb,2021-Sep, 2022
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2021
- Study start31 Oct 2020
- Primary completionSep 2022 (estimated)
- Study completionSep 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Endoscopy, GastrointestinalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 24 participants (estimated)
- Target duration
- 18 Days
Sponsor and investigators
- Lead sponsor
- Dongyang Liu
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Dongyang Liu, Peking University Third Hospital
- Investigators
- Dongyang Liu, Principal investigator, Drug Clinical Trial Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04743726
- Sponsor's protocol ID
- CPPO-PKMS-01
- Status last verified
- Feb 2021
- First submitted
- 27 Jan 2021
- Last updated
- 8 Feb 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Van Den Abeele J, Rubbens J, Brouwers J, Augustijns P. The dynamic gastric environment and its impact on drug and formulation behaviour. Eur J Pharm Sci. 2017 Jan 1;96:207-231. doi: 10.1016/j.ejps.2016.08.060. Epub 2016 Sep 3.
PubMed 27597144Hayashi M, Matsumoto N, Takenoshita-Nakaya S, Takeba Y, Watanabe M, Kumai T, Takagi M, Tanaka M, Otsubo T, Kobayashi S. Individual metabolic capacity evaluation of cytochrome P450 2C19 by protein and activity in the small intestinal mucosa of Japanese pancreatoduodenectomy patients. Biol Pharm Bull. 2011;34(1):71-6. doi: 10.1248/bpb.34.71.
PubMed 21212520Berggren S, Gall C, Wollnitz N, Ekelund M, Karlbom U, Hoogstraate J, Schrenk D, Lennernas H. Gene and protein expression of P-glycoprotein, MRP1, MRP2, and CYP3A4 in the small and large human intestine. Mol Pharm. 2007 Mar-Apr;4(2):252-7. doi: 10.1021/mp0600687. Epub 2007 Jan 31.
PubMed 17263554Kalantzi L, Goumas K, Kalioras V, Abrahamsson B, Dressman JB, Reppas C. Characterization of the human upper gastrointestinal contents under conditions simulating bioavailability/bioequivalence studies. Pharm Res. 2006 Jan;23(1):165-76. doi: 10.1007/s11095-005-8476-1. Epub 2006 Dec 1.
PubMed 16308672Perez de la Cruz Moreno M, Oth M, Deferme S, Lammert F, Tack J, Dressman J, Augustijns P. Characterization of fasted-state human intestinal fluids collected from duodenum and jejunum. J Pharm Pharmacol. 2006 Aug;58(8):1079-89. doi: 10.1211/jpp.58.8.0009.
PubMed 16872555Vasapolli R, Schutte K, Schulz C, Vital M, Schomburg D, Pieper DH, Vilchez-Vargas R, Malfertheiner P. Analysis of Transcriptionally Active Bacteria Throughout the Gastrointestinal Tract of Healthy Individuals. Gastroenterology. 2019 Oct;157(4):1081-1092.e3. doi: 10.1053/j.gastro.2019.05.068. Epub 2019 Jun 5.
PubMed 31175864
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Research on the Physiological Characteristics of the Gastrointestinal Tract in Chinese Volunteers
- ClinicalTrials.gov ID
- NCT04743726
- Acronym / sponsor ID
- CPPO-PKMS-01
- Conditions
- Endoscopy, Gastrointestinal
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Dongyang LiuUniversity, hospital or other
- Study start
- 31 Oct 2020 (actual)
- Primary completion
- Sep 2022 (estimated)
- Study completion
- Sep 2022 (estimated)
- First posted
- 8 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 18 Days
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Endoscopy | – | –Chinese volunteers who are scheduling for gastro-colonoscopy |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Chinese volunteers who are planning to undergo gastrointestinal endoscopy
Key inclusion criteria (9 listed)
- Chinese volunteers who are planning to undergo digestive endoscopy;
- Volunteers who have a full understanding of the content, process and possible adverse reactions of the study and have signed an informed consent form before the clinical trial;
- Volunteers who are able to complete the clinical trial according to the protocol;
- Male and female volunteers between the ages of 18 and 60 (including both ends) on the date of signing the consent form;
- Female volunteers are non-pregnant or non-lactating women, and will live asexually after enrollment until the end of the trial;
Key exclusion criteria (23 listed)
- Volunteers who disagree with "No food or beverages containing caffeine, xanthine and alcohols such as grapefruit-containing products, juice, tea, coffee, wine, etc., 14 days before endoscope", "No smoking 14 days before endoscope";
- Volunteers who do not comply with the relevant regulations about endoscope;
- Volunteers with endoscope contraindications;
- Volunteers with HCV, HIV, HBsAg and/or syphilis positive antibody;
- Volunteers with allergic physique;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The activity and abundance of metabolism enzymes/transports in different section of gastrointestinal tract
Time frame: Feb,2021-Sep, 2022
LC-MS / MS will be used to quantitatively determine the activity of enzymes/transporters and protein content in mucosal samples including CYP1A2, CYP2C9, CYP2C19, CYP2D6, CYP2E1, CYP2J2, CYP3A4, CYP3A5, UGT1A1, UGT1A3, UGT1A4, UGT1A6, UGT1A7, UGT1A8, UGT1A10, UGT2B7, UGT2B17, ABCB1, ABCC2, ABCC3, ABCG2, ASBT, CNT1, CNT2, SGLT1, OATP2B1, OCTN1, OCIN2, OCT1, OCT3, PEPT1.
The physicochemical properties of gastric juice
Time frame: Feb,2021-Sep, 2022
The physicochemical properties of gastric juice including pH, viscosity, buffer capacity, osmotic pressure, and so on will be determined by means of pH-meter, rheometer, burette, freezing point depression, and so on
The composition of gastric juice
Time frame: Feb,2021-Sep, 2022
The composition of protein in gastric juice will be measured by LC-MS/MS or HPLC
The composition and content of bile acid in gastrointestinal mucosa, gastric juice and plasma
Time frame: Feb,2021-Sep, 2022
LC-MS/MS or HPLC will be used to determine the composition of bile acids in mucosal tissues, gastric juice and blood
The distribution of bacterial in gastrointestinal mucosa, saliva, gastric juice and feces
Time frame: Feb,2021-Sep, 2022
The distribution of bacteria in mucosa samples and gastric juice will be determined by high-throughput sequencing
The abundance of bacterial in gastrointestinal mucosa, saliva, gastric juice and feces
Time frame: Feb,2021-Sep, 2022
The abundance of bacteria in mucosa samples and gastric juice will be determined by high-throughput sequencing
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2021.
- Background: PubMed 27597144Van Den Abeele J, Rubbens J, Brouwers J, Augustijns P. The dynamic gastric environment and its impact on drug and formulation behaviour. Eur J Pharm Sci. 2017 Jan 1;96:207-231. doi: 10.1016/j.ejps.2016.08.060. Epub 2016 Sep 3.
- Background: PubMed 21212520Hayashi M, Matsumoto N, Takenoshita-Nakaya S, Takeba Y, Watanabe M, Kumai T, Takagi M, Tanaka M, Otsubo T, Kobayashi S. Individual metabolic capacity evaluation of cytochrome P450 2C19 by protein and activity in the small intestinal mucosa of Japanese pancreatoduodenectomy patients. Biol Pharm Bull. 2011;34(1):71-6. doi: 10.1248/bpb.34.71.
- Background: PubMed 17263554Berggren S, Gall C, Wollnitz N, Ekelund M, Karlbom U, Hoogstraate J, Schrenk D, Lennernas H. Gene and protein expression of P-glycoprotein, MRP1, MRP2, and CYP3A4 in the small and large human intestine. Mol Pharm. 2007 Mar-Apr;4(2):252-7. doi: 10.1021/mp0600687. Epub 2007 Jan 31.
- Background: PubMed 16308672Kalantzi L, Goumas K, Kalioras V, Abrahamsson B, Dressman JB, Reppas C. Characterization of the human upper gastrointestinal contents under conditions simulating bioavailability/bioequivalence studies. Pharm Res. 2006 Jan;23(1):165-76. doi: 10.1007/s11095-005-8476-1. Epub 2006 Dec 1.
- Background: PubMed 16872555Perez de la Cruz Moreno M, Oth M, Deferme S, Lammert F, Tack J, Dressman J, Augustijns P. Characterization of fasted-state human intestinal fluids collected from duodenum and jejunum. J Pharm Pharmacol. 2006 Aug;58(8):1079-89. doi: 10.1211/jpp.58.8.0009.
- Background: PubMed 31175864Vasapolli R, Schutte K, Schulz C, Vital M, Schomburg D, Pieper DH, Vilchez-Vargas R, Malfertheiner P. Analysis of Transcriptionally Active Bacteria Throughout the Gastrointestinal Tract of Healthy Individuals. Gastroenterology. 2019 Oct;157(4):1081-1092.e3. doi: 10.1053/j.gastro.2019.05.068. Epub 2019 Jun 5.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dongyang Liu principal investigator
Drug Clinical Trial Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Endoscopy, Gastrointestinal, run by Dongyang Liu at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The activity and abundance of metabolism enzymes/transports in different section of gastrointestinal tract (time frame: Feb,2021-Sep, 2022). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04743726, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Feb 2021.