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

Primary Purpose

Heart Valve Diseases

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Probiotic mixture
Sponsored by
Hepatopancreatobiliary Surgery Institute of Gansu Province
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Heart Valve Diseases focused on measuring Heart valve diseases, Probiotics, microbiomes, cardiac surgery

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hepatopancreatobiliary Surgery Institute of Gansu ProvinceRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Probiotic mixture

Placebo

Arm Description

Dietary Supplements: Probiotic mixture supplementation The Probiotic mixture supplementation contains Lactobacillus acidophilus, Lactobacillus lactis, and Streptococcus lactis.

Dietary Supplement: Placebo The placebo product will be orally take.

Outcomes

Primary Outcome Measures

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.
Intra-abdominal pressure (IAP)
We defined it as the maximum value of intra-abdominal pressure within 7 days after surgery
Characteristics of gut microbiomes
Feces are collected with sterilized 2 ml tubes and frozen at -80 °C until DNA extraction, preparing for microbe analysis

Secondary Outcome Measures

Return time of bowel sounds
The return time of bowel sounds will be evaluated morning and evening
Number of bowel sounds
The number of bowel sounds will be evaluated morning and evening
First defecation time
The time to the first defecation will be asked morning and evening after surgery
Bristol Stool Form Scale score
Bristol Stool Form Scale is a medical aid designed to classify the form of stool with 7 levels
Proportion of cocci and bacilli in feces
The first feces will be collected in sterile containers for the tertial smear
Procalcitonin (PCT)
Blood samples will be collected on the 1st and 3rd days after operation, for analyses of the PCT
Interleukin-6
Blood samples will be collected on the 1st and 3rd days after operation, for analyses of the Interleukin-6
Interleukin-10
Blood samples will be collected on the 1st and 3rd days after operation, for analyses of the Interleukin-10
High sensitivity troponin(hs TnI)
Blood samples will be collected on the 1st and 3rd days after operation, for analyses of the hs TnI
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
Trimethylamine oxide(TMAO)
Blood samples will be collected on the 1st and 3rd days after operation, for analyses of the TMAO
Intestinal fatty acid-binding protein (IFABP)
Blood samples will be collected on the 1st and 3rd days after operation, for analyses of the IFABP
Left ventricular ejection fraction (LVEF)
Measure the LVEF on the 1st and 3rd days after operation by echocardiographic examinations

Full Information

First Posted
August 10, 2022
Last Updated
July 23, 2023
Sponsor
Hepatopancreatobiliary Surgery Institute of Gansu Province
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1. Study Identification

Unique Protocol Identification Number
NCT05498948
Brief Title
PMS Promotes the Recovery of Patients After Heart Valve Replacement
Acronym
PMS
Official Title
Probiotic Mixture Supplementation (PMS) Promotes the Recovery of Patients After Heart Valve Replacement by Preventing Acute Gastrointestinal Injury (AGI)
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 20, 2022 (Actual)
Primary Completion Date
December 15, 2023 (Anticipated)
Study Completion Date
December 15, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hepatopancreatobiliary Surgery Institute of Gansu Province

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Valve Diseases
Keywords
Heart valve diseases, Probiotics, microbiomes, cardiac surgery

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Probiotic mixture
Arm Type
Experimental
Arm Description
Dietary Supplements: Probiotic mixture supplementation The Probiotic mixture supplementation contains Lactobacillus acidophilus, Lactobacillus lactis, and Streptococcus lactis.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Dietary Supplement: Placebo The placebo product will be orally take.
Intervention Type
Dietary Supplement
Intervention Name(s)
Probiotic mixture
Intervention Description
orally take .
Primary Outcome Measure Information:
Title
The AGI score
Description
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.
Time Frame
1 month
Title
Intra-abdominal pressure (IAP)
Description
We defined it as the maximum value of intra-abdominal pressure within 7 days after surgery
Time Frame
1 month
Title
Characteristics of gut microbiomes
Description
Feces are collected with sterilized 2 ml tubes and frozen at -80 °C until DNA extraction, preparing for microbe analysis
Time Frame
1 month
Secondary Outcome Measure Information:
Title
Return time of bowel sounds
Description
The return time of bowel sounds will be evaluated morning and evening
Time Frame
1 month
Title
Number of bowel sounds
Description
The number of bowel sounds will be evaluated morning and evening
Time Frame
1 month
Title
First defecation time
Description
The time to the first defecation will be asked morning and evening after surgery
Time Frame
1 month
Title
Bristol Stool Form Scale score
Description
Bristol Stool Form Scale is a medical aid designed to classify the form of stool with 7 levels
Time Frame
1 month
Title
Proportion of cocci and bacilli in feces
Description
The first feces will be collected in sterile containers for the tertial smear
Time Frame
1 month
Title
Procalcitonin (PCT)
Description
Blood samples will be collected on the 1st and 3rd days after operation, for analyses of the PCT
Time Frame
1 month
Title
Interleukin-6
Description
Blood samples will be collected on the 1st and 3rd days after operation, for analyses of the Interleukin-6
Time Frame
1 month
Title
Interleukin-10
Description
Blood samples will be collected on the 1st and 3rd days after operation, for analyses of the Interleukin-10
Time Frame
1 month
Title
High sensitivity troponin(hs TnI)
Description
Blood samples will be collected on the 1st and 3rd days after operation, for analyses of the hs TnI
Time Frame
1 month
Title
N-terminal precursor brain natriuretic peptide(NT-ProBNP)
Description
Blood samples will be collected on the 1st and 3rd days after operation, for analyses of the NT-ProBNP
Time Frame
1 month
Title
Trimethylamine oxide(TMAO)
Description
Blood samples will be collected on the 1st and 3rd days after operation, for analyses of the TMAO
Time Frame
1 month
Title
Intestinal fatty acid-binding protein (IFABP)
Description
Blood samples will be collected on the 1st and 3rd days after operation, for analyses of the IFABP
Time Frame
1 month
Title
Left ventricular ejection fraction (LVEF)
Description
Measure the LVEF on the 1st and 3rd days after operation by echocardiographic examinations
Time Frame
1 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Wenbo Meng, M.D. Ph.D,
Phone
+8613919177177
Email
mengwb@lzu.edu.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wenbo Meng, M.D. Ph.D,
Organizational Affiliation
LanZhou University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hepatopancreatobiliary Surgery Institute of Gansu Province
City
Lanzhou
State/Province
Gansu
ZIP/Postal Code
730000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xiaofang Yang, MD,PhD
Phone
+8613893167522
Email
Yangxf20@lzu.edu.cn
First Name & Middle Initial & Last Name & Degree
Wenbo Meng, MD,PhD

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
If patients permitted
Citations:
PubMed Identifier
26682791
Citation
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.
Results Reference
result
PubMed Identifier
35372123
Citation
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.
Results Reference
result

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PMS Promotes the Recovery of Patients After Heart Valve Replacement

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