PMS Promotes the Recovery of Patients After Heart Valve Replacement (NCT05498948) | Clinical Trial Compass
CompletedNot Applicable
PMS Promotes the Recovery of Patients After Heart Valve Replacement
China52 participantsStarted 2022-08-20
Plain-language 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).
Who can participate
Age range
18 Years – 70 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
The AGI score
Timeframe: 1 month
2
Intra-abdominal pressure (IAP)
Timeframe: 1 month
3
Characteristics of gut microbiomes
Timeframe: 1 month
Trial details
NCT IDNCT05498948
SponsorHepatopancreatobiliary Surgery Institute of Gansu Province