Bile RefluxNCT04660058
Associations Among Serum and Gastric Juice Bile Acid Profile, Bile Acid-microbiota Cross-talk in Stomach and the Development of Gastric Cancer
An observational study of Bile Reflux and Gastric Cancer, run by Xijing Hospital of Digestive Diseases at 1 site in China.
Trial summary
To explore the associations among bile acid profile, bile acid-microbiota cross-talk and the development of gastric cancer, so as to better prevent the occurrence and development of gastric cancer Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Bile Reflux, Gastric Cancer, Precancerous Lesion
- How many people
- 73 participants
- Where
- 1 siteChina
- Study dates
- 20 Dec 2020to 30 Jan 2022
- How long will I take part?
- 1 Year
- 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 75 years
- All sexes
- Adult, Older adult
Study population: patients are from Xijing Hospital
Who may be able to join
- Age 18 to 75 years old, gender is not limited;
- No history of antibiotic or probiotic use for 8 weeks;
- No preoperative chemotherapy or radiation therapy prior to the examination;
- Voluntary intravenous blood collection, gastroscopy, extraction of gastric juice and pathological biopsy.
- Voluntary testing for H. pylori
Who cannot join
- had undergone upper gastrointestinal and colon surgery;
- Previous diagnosis of Malignant Tumors;
- Presence of a disease or medication that affects bile acid metabolism, such as endocrine or autoimmune diseases;
- Recent use of drugs that affect gastrointestinal motility;
- Presence of contraindications to endoscopy;
- pregnant and lactating women;
- Those with mental disorders;
- Refusal to sign the informed consent form.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Associations Among Serum and Gastric Juice Bile Acid Profile, Bile Acid-microbiota Cross-talk in Stomach and the Development of Gastric Cancer: A Case-control Study
To explore the associations among bile acid profile, bile acid-microbiota cross-talk and the development of gastric cancer, so as to better prevent the occurrence and development of gastric cancer
Read the detailed description
This study is a case-control study. Patients, according to the pathological results, will be consecutively enrolled and divided into gastric cancer group, gastric precancerous lesions group, and chronic gastritis group. The serum and gastric juice bile acid profiles, gastric microbial composition of each group patients will be detected.
- Conditions
- Bile Reflux, Gastric Cancer, Precancerous Lesion
- Keywords
- bile acid, gastric microbiota, Gastric Cancer, precancerous lesion
- Medical subject headings
- Bile Reflux, Stomach Neoplasms
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 |
|---|---|---|
| chronic gastritis | patients with chronic non-atrophic gastritis and chronic atrophic gastritis according to histopathological results | |
| precancerous lesion | patients with gastric intestinal metaplasia and intraepithelial neoplasia according to histopathological results | |
| gastric cancer | patients with gastric cancer according to histopathological results |
What is being measured
The primary outcome is the main question the study is designed to answer.
corelation between the bile acid profile and gastric mucosa diseases
Investigators evaluate the corelation between the bile acid profile and gastric mucosa diseases according to the results of UPLC-MS/MS and pathological .
Measured: up to 6 months
corelation between the bile acid profile and gastric microbiota in different groups
Investigators explore the cross-talk between bile acid and gastric microbiota according to the results of 16s rRNA sequencing
Measured: up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2020
- Study start20 Dec 2020
- Primary completion30 Dec 2021
- Study completion30 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bile RefluxStudies 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
- Case-control
- Time perspective
- Other
- Enrolment
- 73 participants (actual)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Xijing Hospital of Digestive Diseases
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yongquan Shi, Xijing Hospital of Digestive Diseases
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04660058
- Sponsor's protocol ID
- KY20202100-F-1
- Status last verified
- Jan 2023
- First submitted
- 2 Dec 2020
- Last updated
- 31 Jan 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Associations Among Serum and Gastric Juice Bile Acid Profile, Bile Acid-microbiota Cross-talk in Stomach and the Development of Gastric Cancer: A Case-control Study
- ClinicalTrials.gov ID
- NCT04660058
- Acronym / sponsor ID
- KY20202100-F-1
- Conditions
- Bile Reflux, Gastric Cancer, Precancerous Lesion
- Keywords
- bile acid, gastric microbiota, Gastric Cancer, precancerous lesion
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 73 participants (actual)
- Lead sponsor
- Xijing Hospital of Digestive DiseasesUniversity, hospital or other
- Study start
- 20 Dec 2020 (actual)
- Primary completion
- 30 Dec 2021 (actual)
- Study completion
- 30 Jan 2022 (actual)
- First posted
- 9 Dec 2020 (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.
To explore the associations among bile acid profile, bile acid-microbiota cross-talk and the development of gastric cancer, so as to better prevent the occurrence and development of gastric cancer
Detailed description
This study is a case-control study. Patients, according to the pathological results, will be consecutively enrolled and divided into gastric cancer group, gastric precancerous lesions group, and chronic gastritis group. The serum and gastric juice bile acid profiles, gastric microbial composition of each group patients will be detected.
Study design
- Observational model
- Case-control
- Time perspective
- Other
- Target follow-up
- 1 Year
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| chronic gastritis | – | –patients with chronic non-atrophic gastritis and chronic atrophic gastritis according to histopathological results |
| precancerous lesion | – | –patients with gastric intestinal metaplasia and intraepithelial neoplasia according to histopathological results |
| gastric cancer | – | –patients with gastric cancer according to histopathological results |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- patients are from Xijing Hospital
Key inclusion criteria (5 listed)
- Age 18 to 75 years old, gender is not limited;
- No history of antibiotic or probiotic use for 8 weeks;
- No preoperative chemotherapy or radiation therapy prior to the examination;
- Voluntary intravenous blood collection, gastroscopy, extraction of gastric juice and pathological biopsy.
- Voluntary testing for H. pylori
Key exclusion criteria (8 listed)
- had undergone upper gastrointestinal and colon surgery;
- Previous diagnosis of Malignant Tumors;
- Presence of a disease or medication that affects bile acid metabolism, such as endocrine or autoimmune diseases;
- Recent use of drugs that affect gastrointestinal motility;
- Presence of contraindications to endoscopy;
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
corelation between the bile acid profile and gastric mucosa diseases
Time frame: up to 6 months
Investigators evaluate the corelation between the bile acid profile and gastric mucosa diseases according to the results of UPLC-MS/MS and pathological .
corelation between the bile acid profile and gastric microbiota in different groups
Time frame: up to 6 months
Investigators explore the cross-talk between bile acid and gastric microbiota according to the results of 16s rRNA sequencing
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2023.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Bile Reflux and Gastric Cancer, run by Xijing Hospital of Digestive Diseases 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 5 inclusion and 8 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: finished, as of the sponsor's last update on 31 Jan 2023. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
corelation between the bile acid profile and gastric mucosa diseases (time frame: up to 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 31 Jan 2023.