PMS Promotes the Recovery of Patients After Heart Valve Replacement

Study Overview
=================
Brief 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).

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.

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

Conditions
-----------------
Heart Valve Diseases

Intervention / Treatment
-----------------
* Dietary Supplement: Probiotic mixture


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 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 Exclusion Criteria: 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 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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Probiotic mixture<br>Dietary Supplements: Probiotic mixture supplementation The Probiotic mixture supplementation contains Lactobacillus acidophilus, Lactobacillus lactis, and Streptococcus lactis. | Dietary Supplement: Probiotic mixture<br>* orally take .<br>|
| Placebo Comparator: Placebo<br>Dietary Supplement: Placebo The placebo product will be orally take. | Dietary Supplement: Probiotic mixture<br>* orally take .<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Heart valve diseases, Probiotics, microbiomes, cardiac surgery