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Status unknownNCT05205187MBSUpdated Jan 25, 2022

Gut Microbiota and Metabonomics

An observational study in Stomach Neoplasms, Gut Microbiota and Metabolomics, sponsored by First Hospital of China Medical University. Status unknown at 6 sites in China. Open to participants aged 18 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-01-25.

Sponsored by First Hospital of China Medical University · Observational

The sponsor has not verified this record recently (last verified Jan 2022), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
450
Ages
18 Years to 70 Years
Sex
All
01

Study summary

To evaluate the correlation between gut microbiota and metabolites in Borrmann type IV gastric cancer; To find the effects of microflora and metabolites on target organs; To detect the mechanism of key flora and metabolite by in vitro and in vivo experiments; To construct models of gut microbiota and metabonomics by machine learning.

02

Conditions studied

  • Stomach Neoplasms
  • Gut Microbiota
  • Metabolomics

Browse trials for

03

In context

Stomach Neoplasms

2,914 studies on the registry are indexed under Stomach Neoplasms; 880 are open to participants now.

This study's planned enrollment of 450 is above the median of 281 across 684 observational studies indexed under Stomach Neoplasms.

Browse Stomach Neoplasms studies →

Lead sponsor

First Hospital of China Medical University is the lead sponsor of 61 studies on the registry; 33 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Healthy population will be selected from community samples. Non-Borrmann IV and Borrmann IV patients will be selected from Department of Oncology in hospitals.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Patients who sign informed consent.
  2. Borrmann classification of gastric cancer is determined by more than 2 pathologists.
  3. Patients with BMI 24-28.
  4. Karnofsky (KPS) score >80.

Exclusion criteria

Exclusion Criteria:

  1. Patients who take any aspirin, antibiotics, prebiotics, or probiotics within 4 weeks and steroids or immunosuppressants within 6 months prior to specimen collection.
  2. Patients who complicate with other malignant tumors.
  3. Patients who complicate with diabetes, hypertension, heart disease and infectious diseases.
  4. Patients who complicate with inflammatory bowel disease or irritable bowel syndrome.
  5. Patients with metastasis.
05

Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
450 participants (estimated)
Target follow-up
5 Years
Patient registry
Yes

Groups and cohorts

  • Healthy group

    Healthy people in the community.

    Procedure: Healthy control specimen collection

  • Non-Borrmann IV group

    Patients with Borrmann types I, II and III gastric cancer.

    Procedure: Non-Borrmann IV patient specimen collection

  • Borrmann IV group

    Patients with Borrmann type IV gastric cancer.

    Procedure: Borrmann IV patient specimen collection

Interventions

  • ProcedureHealthy control specimen collection

    Collecting blood and feces from healthy population.

  • ProcedureNon-Borrmann IV patient specimen collection

    Collecting blood, feces and gastric cancer tissues from Non-Borrmann IV patients.

  • ProcedureBorrmann IV patient specimen collection

    Collecting blood, feces and gastric cancer tissues from Borrmann IV patients.

06

What researchers measure

Primary outcomes

  1. Participants' characteristics

    To obtain participants' characteristics, including age, gender, alcohol consumption, body mass index, smoking, medications.

    Time frame: 1 day

  2. Microbial community structure

    To assess participants' microbiome composition in faecal samples, inclding microbial diversity and richness.

    Time frame: 1 day

  3. Metabolite composition

    To measure the metabolite profiles in participants' faecal samples and serum samples, involving Bile acids, short chain fatty acids, TMAO and related metabolites, amino acids, fatty acids, organic acids, flavonoids, plant hormones, neurotransmitters.

    Time frame: 1 day

  4. Microbes-metabolites correlations

    To assess the correlations of gut microbiota and metabolites by Spearman's correlation analysis.

    Time frame: 1 day

  5. Response of target organ

    To find the effects of microflora and metabolites on target organ by transcriptome sequencing.

    Time frame: 1 day

07

Study locations

5 of 6 sites recruiting
  • The fourth People's Hospital of Changzhou
    Changzhou, Jiangsu 213001, China
    • Yan Li · Contact
    Recruiting
  • Chaoyang Central Hospital
    Chaoyang, Liaoning 122099, China
    • Shigang Guo · Contact
    Recruiting
  • The General Hospital of Fushun Mining Bureau
    Fushun, Liaoning 113012, China
    Enrolling by invitation
  • First Hospital of Jinzhou Medical University
    Jinzhou, Liaoning 121012, China
    • Yubin Wang · Contact
    Recruiting
  • The First Affiliated Hospital of China Medical University
    Shenyang, Liaoning 110000, China
    Active, not recruiting
  • The Second Hospital of Shandong University
    Ji'nan, Shandong 250033, China
    Enrolling by invitation
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Feb 2022; primary completion for Jan 2024, 22 months later.

Of 274 non-industry observational studies under Stomach Neoplasms, half reached primary completion within 59 months of starting (the median), counting those still running; a quarter within 30 and three quarters within 171. This study's planned 22 months is below that.

Counting every sponsor, half of 305 studies reached it within 56 months; a quarter within 30 and three quarters within 120.

How these figures are worked out, and which studies are left out of them.

Registered
Jan 11, 2022
First posted
Jan 25, 2022
StartEst.
Feb 28, 2022
Primary completionEst.
Jan 1, 2024
CompletionEst.
Dec 31, 2025
Last update
Jan 25, 2022
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jan 25, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05205187
Lead sponsor
First Hospital of China Medical University
Collaborators
Liaoning Cancer Hospital & Institute, The Second Hospital of Shandong University, The General Hospital of Fushun Mining Bureau, The fourth People's Hospital of Changzhou, The First People's Hospital of Jingzhou
Responsible party
Kai Li (Deputy Director of surgical Oncology, First Hospital of China Medical University) — Principal investigator
First posted
Jan 25, 2022
Start date
Feb 28, 2022 (estimated)
Primary completion
Jan 1, 2024 (estimated)
Completion
Dec 31, 2025 (estimated)
Last update
Jan 25, 2022

Study contacts

Kai Li, MD
Contact
cmu1h_likai@163.com
8613998245233
Kai Li, MD
principal investigator · First Hospital of China Medical University

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jan 2022. You cannot join it, but the record below documents what was studied.

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