PMS Promotes the Recovery of Patients After Heart Valve Replacement

• Sponsor: Hepatopancreatobiliary Surgery Institute of Gansu Province (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05498948
• Collaborator: (none)
• Enrollment: 50
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 5.9
• Patients Per Site Per Month: 8.5

Study Details

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).

Condition or Disease	Intervention/Treatment	Phase
Heart Valve Diseases	Dietary Supplement: Probiotic mixture	N/A

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 50 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Probiotic Mixture Supplementation (PMS) Promotes the Recovery of Patients After Heart Valve Replacement by Preventing Acute Gastrointestinal Injury (AGI)
• Anticipated Study Start Date: Aug 20, 2022
• Anticipated Primary Completion Date: Feb 15, 2023
• Anticipated Study Completion Date: Feb 15, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Probiotic mixture Dietary Supplements: Probiotic mixture supplementation The Probiotic mixture supplementation contains Lactobacillus acidophilus, Lactobacillus lactis, and Streptococcus lactis.	Dietary Supplement: Probiotic mixture; orally take .
Placebo Comparator: Placebo Dietary Supplement: Placebo The placebo product will be orally take.	Dietary Supplement: Probiotic mixture; orally take .

Outcome Measures

Primary Outcome Measures

1. The AGI score [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) [1 month]

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

3. Characteristics of gut microbiomes [1 month]

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

Secondary Outcome Measures

1. Return time of bowel sounds [1 month]

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

2. Number of bowel sounds [1 month]

   The number of bowel sounds will be evaluated morning and evening

3. First defecation time [1 month]

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

4. Bristol Stool Form Scale score [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 [1 month]

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

6. Procalcitonin (PCT) [1 month]

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

7. Interleukin-6 [1 month]

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

8. Interleukin-10 [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) [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) [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) [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) [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) [1 month]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 70 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hepatopancreatobiliary Surgery Institute of Gansu Province	Lanzhou	Gansu	China	730000

Sponsors and Collaborators

• Hepatopancreatobiliary Surgery Institute of Gansu Province

Investigators

• Principal Investigator: Wenbo Meng, M.D. Ph.D,, LanZhou University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Wenbo Meng, Professor of Surgery, Hepatopancreatobiliary Surgery Institute of Gansu Province
• ClinicalTrials.gov Identifier: NCT05498948
• Other Study ID Numbers: PMS
• First Posted: Aug 12, 2022
• Last Update Posted: Aug 15, 2022
• Last Verified: Aug 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Wenbo Meng, Professor of Surgery, Hepatopancreatobiliary Surgery Institute of Gansu Province: Heart valve diseases; Probiotics; microbiomes; cardiac surgery
• Additional relevant MeSH terms: Heart Valve Diseases

Study Results

No Results Posted as of Aug 15, 2022