AzTrials
AzTrials

Heart Valve DiseasesPMSNCT05498948

PMS Promotes the Recovery of Patients After Heart Valve Replacement

A study testing Probiotic mixture in people with Heart Valve Diseases, run by Hepatopancreatobiliary Surgery Institute of Gansu Province at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

Acute gastrointestinal injury (AGI) is related to poor outcomes in patients after heart valve replacement. The purpose of this study is to evaluate the effect of the probiotic mixture supplementation (PMS) in patients after heart valve replacement by preventing acute gastrointestinal injury (AGI). Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Heart Valve Diseases
What is being tested?
Probiotic mixture
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
52 participants
Where
1 siteChina
Study dates
20 Aug 2022to 2 Jan 2024
Phase
Interventional
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 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Moderate to severe congestive heart failure (CHF) (NYHA functional class III to IV)
  • Patients with heart valve diseases undergoing CPB cardiac surgery
  • Age > 18 years and ≤ 70 years

Who cannot join

  • Patients with severe low left ventricular function: LVEF ≤ 30%
  • Patients with infective endocarditis
  • Have received major gastrointestinal surgery (including gallbladder and appendectomy) within 5 years
  • Inflammatory bowel disease (IBD), including ulcerative colitis, Crohn's disease, or colitis
  • Acute gastroenteritis
  • Clostridium difficile or Helicobacter pylori infection
Show all 18Show fewer
  • Chronic constipation
  • Peptic ulcer
  • Polyps in the stomach or intestines
  • Gastrointestinal neoplasms
  • Abdominal hernia
  • Irritable bowel syndrome
  • Acute or chronic cholecystitis, hepatitis
  • Used antibiotics and probiotics in the past 1 month
  • Patients used antidiarrheals, laxatives, or prebiotics within 1 week
  • Pregnant or pregnant during follow-up
  • Failure to give informed consent (e.g. severe cognitive impairment)
  • The patient has been enrolled in other ongoing clinical trials

Trial locations and contacts

1 site in 1 country.

China1 site

  • Hepatopancreatobiliary Surgery Institute of Gansu Province

    Lanzhou, Gansu, 730000

Other trials in China

About this study

Official title: Probiotic Mixture Supplementation (PMS) Promotes the Recovery of Patients After Heart Valve Replacement by Preventing Acute Gastrointestinal Injury (AGI)

Acute gastrointestinal injury (AGI) is related to poor outcomes in patients after heart valve replacement. The purpose of this study is to evaluate the effect of the probiotic mixture supplementation (PMS) in patients after heart valve replacement by preventing acute gastrointestinal injury (AGI).

Read the detailed description

Patients with heart valve diseases often have chronic cardiac insufficiency. Accumulating evidence supports a relationship between the complexity and diversity of the gut microbiota and heart failure. Bacterial colonization and translocation of their toxins to the bloodstream due to altered intestinal permeability are directly correlated with systemic inflammation. The activation of pro-inflammatory pathways and chronic inflammation was hypothesized as a major contributing factor in the pathogenicity and progression of heart failure (HF) Patients undergoing heart valve replacement with cardiopulmonary bypass (CPB) are always complicated with gastrointestinal tract ischemia-reperfusion injury, which usually leads to AGI. AGI is related to poor outcomes of critically ill patients through many underlying mechanisms. It can leads to infectious complications, multiple organ dysfunction syndromes (MODS), and even death. On the other hand, the supply of probiotics, the good bacteria, is beneficial, despite still having a few controversial results. Therefore, it is important to carefully assess the efficacy of probiotics in the prevention of AGI and other complications in patients undergoing heart valve replacement surgery with CPB, as well as to evaluate the safety of its use.

Being tested
Probiotic mixture
Keywords
Heart valve diseases, Probiotics, microbiomes, cardiac surgery
Medical subject headings
Heart Valve Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Probiotic mixtureDietary supplement

    orally take .

Study groups in NCT05498948
Study groupRoleWhat they receive
Probiotic mixtureExperimentalDietary Supplements: Probiotic mixture supplementation The Probiotic mixture supplementation contains Lactobacillus rhamnosus CMCC(B) P0028 ；Lactobacillus rhamnosus CMCC(B) P0029；Enterococcus faecium CMCC(B) P0030
Receives: Dietary Supplement: Probiotic mixture
PlaceboPlacebo comparatorDietary Supplement: Placebo The placebo product will be orally take.
Receives: Dietary Supplement: Probiotic mixture

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The AGI score

    The AGI score of the patient within the 7th postoperative day was performed according to the European Society of critical care (2012) guidelines for AGI.

    Measured: 1 month

  2. Intra-abdominal pressure (IAP)

    We defined it as the maximum value of intra-abdominal pressure within 7 days after surgery

    Measured: 1 month

  3. Characteristics of gut microbiomes

    Feces are collected with sterilized 2 ml tubes and frozen at -80 °C until DNA extraction, preparing for microbe analysis

    Measured: 1 month

Secondary outcomes (13)

  1. Return time of bowel sounds

    The return time of bowel sounds will be evaluated morning and evening

    Measured: 1 month

  2. Number of bowel sounds

    The number of bowel sounds will be evaluated morning and evening

    Measured: 1 month

  3. First defecation time

    The time to the first defecation will be asked morning and evening after surgery

    Measured: 1 month

  4. Bristol Stool Form Scale score

    Bristol Stool Form Scale is a medical aid designed to classify the form of stool with 7 levels

    Measured: 1 month

  5. Proportion of cocci and bacilli in feces

    The first feces will be collected in sterile containers for the tertial smear

    Measured: 1 month

  6. Procalcitonin (PCT)

    Blood samples will be collected on the 1st and 3rd days after operation, for analyses of the PCT

    Measured: 1 month

  7. Interleukin-6

    Blood samples will be collected on the 1st and 3rd days after operation, for analyses of the Interleukin-6

    Measured: 1 month

  8. Interleukin-10

    Blood samples will be collected on the 1st and 3rd days after operation, for analyses of the Interleukin-10

    Measured: 1 month

  9. High sensitivity troponin(hs TnI)

    Blood samples will be collected on the 1st and 3rd days after operation, for analyses of the hs TnI

    Measured: 1 month

  10. N-terminal precursor brain natriuretic peptide(NT-ProBNP)

    Blood samples will be collected on the 1st and 3rd days after operation, for analyses of the NT-ProBNP

    Measured: 1 month

  11. Trimethylamine oxide(TMAO)

    Blood samples will be collected on the 1st and 3rd days after operation, for analyses of the TMAO

    Measured: 1 month

  12. Intestinal fatty acid-binding protein (IFABP)

    Blood samples will be collected on the 1st and 3rd days after operation, for analyses of the IFABP

    Measured: 1 month

  13. Left ventricular ejection fraction (LVEF)

    Measure the LVEF on the 1st and 3rd days after operation by echocardiographic examinations

    Measured: 1 month

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Aug 2022
  2. Study start20 Aug 2022
  3. Primary completion2 Jan 2024
  4. Study completion2 Jan 2024

Resources

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
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
52 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05498948
Sponsor's protocol ID
PMS
Acronym
PMS
Status last verified
Apr 2025
First submitted
10 Aug 2022
Last updated
17 Apr 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: If patients permitted

Publications

  • Pasini E, Aquilani R, Testa C, Baiardi P, Angioletti S, Boschi F, Verri M, Dioguardi F. Pathogenic Gut Flora in Patients With Chronic Heart Failure. JACC Heart Fail. 2016 Mar;4(3):220-7. doi: 10.1016/j.jchf.2015.10.009. Epub 2015 Dec 9.

    PubMed 26682791

  • Chen Y, Zhang F, Ye X, Hu JJ, Yang X, Yao L, Zhao BC, Deng F, Liu KX. Association Between Gut Dysbiosis and Sepsis-Induced Myocardial Dysfunction in Patients With Sepsis or Septic Shock. Front Cell Infect Microbiol. 2022 Mar 14;12:857035. doi: 10.3389/fcimb.2022.857035. eCollection 2022.

    PubMed 35372123

  • Yang X, Liu R, An Z, Li B, Lin Y, Li Y, Song B, Yuan J, Meng W, Waydhas C. Probiotic mitigates gut hypoperfusion-associated acute gastrointestinal injury in patients undergoing cardiopulmonary bypass: a randomized controlled trial. BMC Med. 2025 Apr 23;23(1):238. doi: 10.1186/s12916-025-04082-2.

    PubMed 40264088

Questions about this trial

What is this clinical trial studying?

A study testing Probiotic mixture in people with Heart Valve Diseases, run by Hepatopancreatobiliary Surgery Institute of Gansu Province 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 3 inclusion and 18 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 17 Apr 2025. 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. Some participants in this study may receive a placebo. 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?

The AGI score (time frame: 1 month). The study lists 3 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 NCT05498948, which also lists 3 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 17 Apr 2025.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in