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Completed

NCT Number: NCT05498948

PMS Promotes the Recovery of Patients After Heart Valve Replacement

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).

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hepatopancreatobiliary Surgery Institute of Gansu Province

Lanzhou, Gansu, 730000, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Probiotic mixture

Dietary Supplement

orally take .

Primary outcomes

  1. The AGI score

    Time frame: 1 month

    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.

  2. Intra-abdominal pressure (IAP)

    Time frame: 1 month

    We defined it as the maximum value of intra-abdominal pressure within 7 days after surgery

  3. Characteristics of gut microbiomes

    Time frame: 1 month

    Feces are collected with sterilized 2 ml tubes and frozen at -80 °C until DNA extraction, preparing for microbe analysis

Secondary outcomes

  1. Return time of bowel sounds

    Time frame: 1 month

    The return time of bowel sounds will be evaluated morning and evening

  2. Number of bowel sounds

    Time frame: 1 month

    The number of bowel sounds will be evaluated morning and evening

  3. First defecation time

    Time frame: 1 month

    The time to the first defecation will be asked morning and evening after surgery

  4. Bristol Stool Form Scale score

    Time frame: 1 month

    Bristol Stool Form Scale is a medical aid designed to classify the form of stool with 7 levels

  5. Proportion of cocci and bacilli in feces

    Time frame: 1 month

    The first feces will be collected in sterile containers for the tertial smear

  6. Procalcitonin (PCT)

    Time frame: 1 month

    Blood samples will be collected on the 1st and 3rd days after operation, for analyses of the PCT

  7. Interleukin-6

    Time frame: 1 month

    Blood samples will be collected on the 1st and 3rd days after operation, for analyses of the Interleukin-6

  8. Interleukin-10

    Time frame: 1 month

    Blood samples will be collected on the 1st and 3rd days after operation, for analyses of the Interleukin-10

  9. High sensitivity troponin(hs TnI)

    Time frame: 1 month

    Blood samples will be collected on the 1st and 3rd days after operation, for analyses of the hs TnI

  10. N-terminal precursor brain natriuretic peptide(NT-ProBNP)

    Time frame: 1 month

    Blood samples will be collected on the 1st and 3rd days after operation, for analyses of the NT-ProBNP

  11. Trimethylamine oxide(TMAO)

    Time frame: 1 month

    Blood samples will be collected on the 1st and 3rd days after operation, for analyses of the TMAO

  12. Intestinal fatty acid-binding protein (IFABP)

    Time frame: 1 month

    Blood samples will be collected on the 1st and 3rd days after operation, for analyses of the IFABP

  13. Left ventricular ejection fraction (LVEF)

    Time frame: 1 month

    Measure the LVEF on the 1st and 3rd days after operation by echocardiographic examinations

Sponsors and collaborators

Lead sponsor

Hepatopancreatobiliary Surgery Institute of Gansu Province

Other

Registry information

Official study title

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

Acronym: PMS

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Aug 12, 2022
Registry last updated
Apr 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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