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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Probiotic mixture | Experimental | Dietary Supplements: Probiotic mixture supplementation The Probiotic mixture supplementation contains Lactobacillus rhamnosus CMCC(B) P0028 ï¼›Lactobacillus rhamnosus CMCC(B) P0029ï¼›Enterococcus faecium CMCC(B) P0030 |
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| Placebo | Placebo Comparator | Dietary Supplement: Placebo The placebo product will be orally take. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Probiotic mixture | Dietary Supplement | orally take . |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | 1 month |
| Intra-abdominal pressure (IAP) | We defined it as the maximum value of intra-abdominal pressure within 7 days after surgery | 1 month |
| Characteristics of gut microbiomes | Feces are collected with sterilized 2 ml tubes and frozen at -80 °C until DNA extraction, preparing for microbe analysis | 1 month |
| Measure | Description | Time Frame |
|---|---|---|
| Return time of bowel sounds | The return time of bowel sounds will be evaluated morning and evening | 1 month |
| Number of bowel sounds | The number of bowel sounds will be evaluated morning and evening |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Wenbo Meng, M.D. Ph.D, | LanZhou University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hepatopancreatobiliary Surgery Institute of Gansu Province | Lanzhou | Gansu | 730000 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26682791 | Result | 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. | |
| 35372123 | Result | 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. |
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If patients permitted
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| ID | Term |
|---|---|
| D006349 | Heart Valve Diseases |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| 1 month |
| First defecation time | The time to the first defecation will be asked morning and evening after surgery | 1 month |
| Bristol Stool Form Scale score | Bristol Stool Form Scale is a medical aid designed to classify the form of stool with 7 levels | 1 month |
| Proportion of cocci and bacilli in feces | The first feces will be collected in sterile containers for the tertial smear | 1 month |
| Procalcitonin (PCT) | Blood samples will be collected on the 1st and 3rd days after operation, for analyses of the PCT | 1 month |
| Interleukin-6 | Blood samples will be collected on the 1st and 3rd days after operation, for analyses of the Interleukin-6 | 1 month |
| Interleukin-10 | Blood samples will be collected on the 1st and 3rd days after operation, for analyses of the Interleukin-10 | 1 month |
| High sensitivity troponin(hs TnI) | Blood samples will be collected on the 1st and 3rd days after operation, for analyses of the hs TnI | 1 month |
| 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 | 1 month |
| Trimethylamine oxide(TMAO) | Blood samples will be collected on the 1st and 3rd days after operation, for analyses of the TMAO | 1 month |
| Intestinal fatty acid-binding protein (IFABP) | Blood samples will be collected on the 1st and 3rd days after operation, for analyses of the IFABP | 1 month |
| Left ventricular ejection fraction (LVEF) | Measure the LVEF on the 1st and 3rd days after operation by echocardiographic examinations | 1 month |
| 40264088 | Derived | 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. |