Gut MicrobiotaNCT06513416
Gut Microbiota and Pulmonary Complications After Non Cardiac Elective Surgery in Elderly Patients
An observational study of Gut Microbiota and Postoperative Pulmonary Complications, run by Peking Union Medical College Hospital at 1 site in China.
Trial summary
An observational cohort was established using preoperatively collected biospecimens and prospectively ascertained postoperative outcomes. A nested case-control metagenomic analysis was subsequently conducted within the cohort, including participants with grade II or higher PPCs and selected participants without PPCs. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Gut Microbiota, Postoperative Pulmonary Complications
- What is being tested?
- Elective abdominal surgery
- Type of treatment
- Surgery or procedure
- How many people
- 265 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2023to 28 Feb 2026
- 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: Elderly patients over 65 years old who plan to undergo elective major abdominal surgery
Who may be able to join
- Age: ≥ 65 years old;
- Surgery: Major abdominal surgery (expected duration ≥ 2 hours);
- Anesthesia methods: general anesthesia, tracheal intubation;
- ASA classification: I-IV levels;
- Postoperative Pulmonary Complications Risk Score (ARISCAT): Medium to High Risk
- Patients or their families are able to understand the research protocol and are willing to participate in this study, providing written informed consent
Who cannot join
- Emergency surgery;
- This is the second surgery within the past month;
- Preoperative presence of pulmonary infection or other serious pulmonary complications
- Patients who have used antibiotics, probiotics, and acid suppressants within one month before surgery
Trial locations and contacts
1 site in 1 country.
China1 site
Department of Anesthesiology, Peking Union Medical College Hospital
Beijing, Beijing Municipality, 100730
About this study
An observational cohort was established using preoperatively collected biospecimens and prospectively ascertained postoperative outcomes. A nested case-control metagenomic analysis was subsequently conducted within the cohort, including participants with grade II or higher PPCs and selected participants without PPCs.
- Being tested
- Elective abdominal surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Elective abdominal surgeryProcedure or surgery
The included elderly patients are those who are preparing for elective abdominal surgery and the surgery time exceeds 2 hours.
| Study group | Role | What they receive |
|---|---|---|
| Elderly surgical patients | Adults aged 65 years or older undergoing major non-cardiac surgery of expected duration of at least 2 hours under general anesthesia with tracheal intubation. Participants are followed for postoperative pulmonary complications within 7 days after surgery, and preoperative biospecimens are collected when feasible with participant consent. Receives: Procedure: Elective abdominal surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with postoperative pulmonary complications
The primary outcome is the occurrence of one or more ppcs, including primarily hypoxemia, atelectasis, and pneumonia, etc.
Measured: Within 7 days after surgery
Secondary outcomes (2)
Preoperative gut microbiome composition
Taxonomic composition and relative abundance derived from shotgun metagenomic sequencing of eligible preoperative faecal samples.
Measured: Preoperative, before bowel preparation and prophylactic antibiotics
Concentration of inflammatory cytokines in peripheral blood before and after surgery
Inflammatory factors include high-sensitivity C-reactive protein (CRP) and procalcitonin (PCT)
Measured: Before and within 7 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2024
- Study start1 May 2023
- Primary completion28 Feb 2026
- Study completion28 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gut MicrobiotaStudies of the same condition, open and under way.
- More trials run by Peking Union Medical College HospitalThe sponsor's other registered studies.
- 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
- 265 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Huang YuGuang, Peking Union Medical College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06513416
- Sponsor's protocol ID
- K5484
- Status last verified
- Aug 2026
- First submitted
- 17 Jul 2024
- Last updated
- 16 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gut Microbiota and Pulmonary Complications After Non Cardiac Elective Surgery in Elderly Patients
- ClinicalTrials.gov ID
- NCT06513416
- Acronym / sponsor ID
- K5484
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 265 participants (actual)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Study start
- 1 May 2023 (actual)
- Primary completion
- 28 Feb 2026 (actual)
- Study completion
- 28 Feb 2026 (actual)
- First posted
- 22 Jul 2024 (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.
An observational cohort was established using preoperatively collected biospecimens and prospectively ascertained postoperative outcomes. A nested case-control metagenomic analysis was subsequently conducted within the cohort, including participants with grade II or higher PPCs and selected participants without PPCs.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Elderly surgical patients | – | Procedure: Elective abdominal surgeryAdults aged 65 years or older undergoing major non-cardiac surgery of expected duration of at least 2 hours under general anesthesia with tracheal intubation. Participants are followed for postoperative pulmonary complications within 7 days after surgery, and preoperative biospecimens are collected when feasible with participant consent. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Elderly patients over 65 years old who plan to undergo elective major abdominal surgery
Key inclusion criteria (6 listed)
- Age: ≥ 65 years old;
- Surgery: Major abdominal surgery (expected duration ≥ 2 hours);
- Anesthesia methods: general anesthesia, tracheal intubation;
- ASA classification: I-IV levels;
- Postoperative Pulmonary Complications Risk Score (ARISCAT): Medium to High Risk
Key exclusion criteria (4 listed)
- Emergency surgery;
- This is the second surgery within the past month;
- Preoperative presence of pulmonary infection or other serious pulmonary complications
- Patients who have used antibiotics, probiotics, and acid suppressants within one month before surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Elective abdominal surgeryThe included elderly patients are those who are preparing for elective abdominal surgery and the surgery time exceeds 2 hours. | Procedure or surgery | Elderly surgical patients |
Primary outcome
Number of participants with postoperative pulmonary complications
Time frame: Within 7 days after surgery
The primary outcome is the occurrence of one or more ppcs, including primarily hypoxemia, atelectasis, and pneumonia, etc.
2 secondary outcomes
Preoperative gut microbiome composition
Time frame: Preoperative, before bowel preparation and prophylactic antibiotics
Concentration of inflammatory cytokines in peripheral blood before and after surgery
Time frame: Before and within 7 days after surgery
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 16 Sep 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Gut Microbiota
Recruiting
Colon-delivered Riboflavin and Gut Microbiota Composition
Microbiome Dysbiosis, Gut Health
Active, not recruiting
Effect of Probiotics on Insulin Sensitivity in Overweight and Obese Pregnancy
Obesity & Overweight, Gestational Diabetes Mellitus (GDM)
Active, not recruiting
SweetSpot - The Effect of Non-nutritive Sweeteners on Health
Healthy Adult
Enrolling by invitation
Dance-Based Exercise for Cancer-Related Fatigue in Breast Cancer Patients
Breast Neoplasms
Recruiting
The Effect of a Synbiotic on Intestinal Barrier Function and Microbiota Modulation in Middle-aged to Elderly Individuals
Gastrointestinal Microbiome (Focus), Gastrointestinal Symptoms
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 Gut Microbiota and Postoperative Pulmonary Complications, run by Peking Union Medical College Hospital 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 6 inclusion and 4 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 16 Sep 2026. 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?
Number of participants with postoperative pulmonary complications (time frame: Within 7 days after surgery). 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 16 Sep 2026.