Clinical trial NCT05498948: PMS Promotes the Recovery of Patients After Heart Valve Replacement
Official title: Probiotic Mixture Supplementation (PMS) Promotes the Recovery of Patients After Heart Valve Replacement by Preventing Acute Gastrointestinal Injury (AGI)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Heart Valve Diseases
Keywords: Heart valve diseases
Probiotics
microbiomes
cardiac surgery
Lead sponsor: Hepatopancreatobiliary Surgery Institute of Gansu Province
Sponsor class: OTHER
First posted: 2022-08-12
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: The AGI score
timeFrame: 1 month
measure: Intra-abdominal pressure (IAP)
timeFrame: 1 month
measure: Characteristics of gut microbiomes
timeFrame: 1 month
Secondary outcomes:
measure: Return time of bowel sounds
timeFrame: 1 month
measure: Number of bowel sounds
timeFrame: 1 month
measure: First defecation time
timeFrame: 1 month
measure: Bristol Stool Form Scale score
timeFrame: 1 month
measure: Proportion of cocci and bacilli in feces
timeFrame: 1 month
measure: Procalcitonin (PCT)
timeFrame: 1 month
measure: Interleukin-6
timeFrame: 1 month
measure: Interleukin-10
timeFrame: 1 month
measure: High sensitivity troponin(hs TnI)
timeFrame: 1 month
measure: N-terminal precursor brain natriuretic peptide(NT-ProBNP)
timeFrame: 1 month
measure: Trimethylamine oxide(TMAO)
timeFrame: 1 month
measure: Intestinal fatty acid-binding protein (IFABP)
timeFrame: 1 month
measure: Left ventricular ejection fraction (LVEF)
timeFrame: 1 month
Other outcomes:
Locations:
city: Lanzhou
country: China
facility: Hepatopancreatobiliary Surgery Institute of Gansu Province
state: Gansu
Study officials:
affiliation: LanZhou University
name: Wenbo Meng, M.D. Ph.D,
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.