PMS Promotes the Recovery of Patients After Heart Valve Replacement

Hepatopancreatobiliary Surgery Institute of Gansu Province

Status: Completed

Conditions: Heart Valve Diseases

Treatments: Dietary Supplement: Probiotic mixture

Study type: Interventional

Funder types: Other

Identifiers

NCT05498948

PMS

Details and patient eligibility

About

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).

Full 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.

Enrollment: 52 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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52 participants in 2 patient groups, including a placebo group

Probiotic mixture

Experimental group

Description:

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

Treatment:

Dietary Supplement: Probiotic mixture

Placebo

Placebo Comparator group

Description:

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

Treatment:

Dietary Supplement: Probiotic mixture