Cardiovascular DiseasePANDANCT04444362
Protective Effect of Probacine Against Negative Gut Metabolism and Organ Dysfunction After Cardiovascular Surgery (PANDA IV)
A study testing Intestinal Microbiota Transplant (IMT) Capsules in people with Cardiovascular Disease and Cardiopulmonary Bypass, run by Nanjing Medical University at 5 sites in China.
Trial summary
Cardiovascular diseases (CVDs) continue to be the primary cause of illness and death globally, emphasizing the pressing requirement for efficient prevention methods. Recent studies indicate that the gut microbiome plays a vital role in maintaining cardiovascular health, affecting the pathophysiological mechanisms… Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Cardiovascular Disease, Cardiopulmonary Bypass
- What is being tested?
- Intestinal Microbiota Transplant (IMT) Capsules
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 5 sitesChina
- Study dates
- 1 Jan 2025to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult men and women;
- Cardiovascular surgery;
- Agree to participate in the study and sign the informed consent form.
Who cannot join
- Pregnant women;
- Patients with preexisting psychotic disorders;
- Decline to participate in the study.
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
5 sites in 1 country
China5 sites
Beijing Anzhen Hospital
Beijing, Beijing Municipality
West China Hospital of Sichuan University
Chengdu, Sichuan
The First Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong
The First Affiliated Hospital of Nanjing Medical University
Nanjing, Jiangsu, 210029
Shanghai East Hospital, Tongji University
Shanghai
About this study
Official title: Protective Effect of Probacine Against Negative Gut Metabolism and Organ Dysfunction After Cardiovascular Surgery: A Randomized Controlled Trial
Cardiovascular diseases (CVDs) continue to be the primary cause of illness and death globally, emphasizing the pressing requirement for efficient prevention methods. Recent studies indicate that the gut microbiome plays a vital role in maintaining cardiovascular health, affecting the pathophysiological mechanisms related to CVDs. The potential therapeutic strategies for primary care practitioners included the modulation of the gut microbiome through dietary changes, prebiotics, and probiotics. The aim of this study was to investage the effect of gut microbiome modulation on clinical outcomes after cardiac surgery.
- Conditions
- Cardiovascular Disease, Cardiopulmonary Bypass
- Being tested
- Intestinal Microbiota Transplant (IMT) Capsules
- Keywords
- Gut microbiota
- Medical subject headings
- Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intestinal Microbiota Transplant (IMT) CapsulesDrug
Intestinal Microbiota Transplant (IMT) Capsules were administered 7 days preoperatively and 14 days postoperatively.
| Study group | Role | What they receive |
|---|---|---|
| Intestinal Microbial Transformation (IMT) | Experimental | The Intestinal Microbial Transformation (IMT) group received Probacine, in addition to standard treatment and care, including prophylactic antibiotics , fluid therapy, and enteral nutrition supports. Receives: Drug: Intestinal Microbiota Transplant (IMT) Capsules |
| Control | No intervention | The control group received standard treatment and care, including prophylactic antibiotics , fluid therapy, and enteral nutrition supports. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acute Gastrointestinal Injury
Measured: 14 days after surgery
Secondary outcomes (2)
ΔSOFA
the difference between the mean total postoperative SOFA score and baseline score within 24 hours of surgery during the index admission
Measured: 7 days after surgery
30-day mortality rate
defined as mortality within 30 days postoperatively in the hospital or anywhere after discharge;
Measured: 30 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 posted23 Jun 2020
- Study start1 Jan 2025
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular DiseaseStudies of the same condition, open and under way.
- More trials run by Nanjing Medical UniversityThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nanjing Medical University
- Sponsor type
- University, hospital or other
- Collaborators
- Shanghai East Hospital of Tongji University, West China Hospital, The First Affiliated Hospital of Guangzhou Medical University
- Responsible party
- Principal investigator, Hong Liu, Nanjing Medical University
- Investigators
- Guo-liang Fan, Study director, Shanghai East Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04444362
- Sponsor's protocol ID
- PANDA IV
- Acronym
- PANDA
- Status last verified
- Jan 2026
- First submitted
- 20 Jun 2020
- Last updated
- 6 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Protective Effect of Probacine Against Negative Gut Metabolism and Organ Dysfunction After Cardiovascular Surgery: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04444362
- Acronym / sponsor ID
- PANDA / PANDA IV
- Conditions
- Cardiovascular Disease, Cardiopulmonary Bypass
- Keywords
- Gut microbiota
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Nanjing Medical UniversityUniversity, hospital or other
- Collaborators
- Shanghai East Hospital of Tongji University, West China Hospital, The First Affiliated Hospital of Guangzhou Medical University
- Study start
- 1 Jan 2025 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 23 Jun 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.
Cardiovascular diseases (CVDs) continue to be the primary cause of illness and death globally, emphasizing the pressing requirement for efficient prevention methods. Recent studies indicate that the gut microbiome plays a vital role in maintaining cardiovascular health, affecting the pathophysiological mechanisms related to CVDs. The potential therapeutic strategies for primary care practitioners included the modulation of the gut microbiome through dietary changes, prebiotics, and probiotics. The aim of this study was to investage the effect of gut microbiome modulation on clinical outcomes after cardiac surgery.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intestinal Microbial Transformation (IMT) | Experimental | Drug: Intestinal Microbiota Transplant (IMT) CapsulesThe Intestinal Microbial Transformation (IMT) group received Probacine, in addition to standard treatment and care, including prophylactic antibiotics , fluid therapy, and enteral nutrition supports. |
| Control | No intervention | –The control group received standard treatment and care, including prophylactic antibiotics , fluid therapy, and enteral nutrition supports. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adult men and women;
- Cardiovascular surgery;
- Agree to participate in the study and sign the informed consent form.
Key exclusion criteria (3 listed)
- Pregnant women;
- Patients with preexisting psychotic disorders;
- Decline to participate in the study.
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 |
|---|---|---|
| Intestinal Microbiota Transplant (IMT) CapsulesIntestinal Microbiota Transplant (IMT) Capsules were administered 7 days preoperatively and 14 days postoperatively. | Drug | Intestinal Microbial Transformation (IMT) |
Primary outcome
Acute Gastrointestinal Injury
Time frame: 14 days after surgery
2 secondary outcomes
ΔSOFA
Time frame: 7 days after surgery
30-day mortality rate
Time frame: 30 days after surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2026.
- 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.
Guo-liang Fan study director
Shanghai East Hospital
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intestinal Microbiota Transplant (IMT) Capsules in people with Cardiovascular Disease and Cardiopulmonary Bypass, run by Nanjing Medical University at 5 sites 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 3 inclusion and 3 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: enrolling by invitation, as of the sponsor's last update on 6 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites 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?
This study is still under way. Results are not available in the source record yet.
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?
Acute Gastrointestinal Injury (time frame: 14 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 6 Jan 2026.