NCT05498948

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
52

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 10, 2022

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 12, 2022

Completed
8 days until next milestone

Study Start

First participant enrolled

August 20, 2022

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 2, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 2, 2024

Completed
Last Updated

April 17, 2025

Status Verified

April 1, 2025

Enrollment Period

1.4 years

First QC Date

August 10, 2022

Last Update Submit

April 14, 2025

Conditions

Heart Valve Diseases

Keywords

Heart valve diseasesProbioticsmicrobiomescardiac surgery

Outcome Measures

Primary Outcomes (3)

  • 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.

    1 month

  • Intra-abdominal pressure (IAP)

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

    1 month

  • Characteristics of gut microbiomes

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

    1 month

Secondary Outcomes (13)

  • Return time of bowel sounds

    1 month

  • Number of bowel sounds

    1 month

  • First defecation time

    1 month

  • Bristol Stool Form Scale score

    1 month

  • Proportion of cocci and bacilli in feces

    1 month

  • +8 more secondary outcomes

Study Arms (2)

Probiotic mixture

EXPERIMENTAL

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

Dietary Supplement: Probiotic mixture

Placebo

PLACEBO COMPARATOR

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

Dietary Supplement: Probiotic mixture

Interventions

Probiotic mixtureDIETARY_SUPPLEMENT

orally take .

PlaceboProbiotic mixture

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • +3 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hepatopancreatobiliary Surgery Institute of Gansu Province

Lanzhou, Gansu, 730000, China

Location

Related Publications (3)

  • 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.

    PMID: 26682791RESULT

  • 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.

    PMID: 35372123RESULT

  • Yang X, Liu R, An Z, Li B, Lin Y, Li Y, Song B, Yuan J, Meng W, Waydhas C. Probiotic mitigates gut hypoperfusion-associated acute gastrointestinal injury in patients undergoing cardiopulmonary bypass: a randomized controlled trial. BMC Med. 2025 Apr 23;23(1):238. doi: 10.1186/s12916-025-04082-2.

    PMID: 40264088DERIVED

MeSH Terms

Conditions

Heart Valve Diseases

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Study Officials

  • Wenbo Meng, M.D. Ph.D,

    LanZhou University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Surgery

Study Record Dates

First Submitted

August 10, 2022

First Posted

August 12, 2022

Study Start

August 20, 2022

Primary Completion

January 2, 2024

Study Completion

January 2, 2024

Last Updated

April 17, 2025

Record last verified: 2025-04

Data Sharing

IPD Sharing
Will not share

If patients permitted

Locations

CN(1)