PMS Promotes the Recovery of Patients After Heart Valve Replacement (PMS)

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).

Study Overview

• Status: Completed
• Conditions: Heart Valve Diseases
• Intervention / Treatment: Dietary supplement: Probiotic mixture

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.

• Study Type: Interventional
• Enrollment (Actual): 52
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Gansu
    • Lanzhou, Gansu, China, 730000
      • Hepatopancreatobiliary Surgery Institute of Gansu Province

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; Dietary Supplement: Placebo The placebo product will be orally take.	Dietary supplement: Probiotic mixture; orally take .
Experimental: Probiotic mixture; Dietary Supplements: Probiotic mixture supplementation The Probiotic mixture supplementation contains Lactobacillus rhamnosus CMCC(B) P0028 ；Lactobacillus rhamnosus CMCC(B) P0029；Enterococcus faecium CMCC(B) P0030	Dietary supplement: Probiotic mixture; orally take .

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

Collaborators and Investigators

• Sponsor: Hepatopancreatobiliary Surgery Institute of Gansu Province
• Investigators: Principal Investigator: Wenbo Meng, M.D. Ph.D,, LanZhou University

Publications and helpful links

General 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): August 20, 2022
• Primary Completion (Actual): January 2, 2024
• Study Completion (Actual): January 2, 2024

Study Registration Dates

• First Submitted: August 10, 2022
• First Submitted That Met QC Criteria: August 10, 2022
• First Posted (Actual): August 12, 2022

Study Record Updates

• Last Update Posted (Actual): April 17, 2025
• Last Update Submitted That Met QC Criteria: April 14, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Keywords: cardiac surgery; Probiotics; microbiomes; Heart valve diseases
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Heart Diseases; Heart Valve Diseases
• Other Study ID Numbers: PMS

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: If patients permitted

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No