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New treatment option for Delirium
Official title Fecal Microbiota Transplantation for the Treatment of ICU Delirium
ClinicalTrials.gov ID: NCT07348471
What this study is testing
- What it's testing
- Delirium in the intensive care unit (ICU) is a prevalent and serious neurological complication among critically ill patients, with large multicenter studies reporting an incidence of 30% to 80%, particularly in those requiring mechanical ventilation. Delirium is not only associated with prolonged ICU and hospital stays but also with increased morbidity and mortality.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 80
You may be able to join if
- 1\. Age ≥ 18 years old, no ethnic or gender restrictions;
- 2\. CAM-ICU-positive delirium;
- 3\. Expected ICU stay ≥ 5 days after inclusion in the study;
- 4\. Signed written informed consent.
You likely can't join if
- 1\. Routine administration of antipsychotic medications: Conventional antipsychotic therapy refers to the daily ingestion or application of any...
- Typical antipsychotics: Chlorprothixene, Flupentixol, Haloperidol, Levomepromazine, Loxapine, Melperone, Perphenazine, Pericyazine, Pimozide...
- Atypical antipsychotics: Amisulpride, Aripiprazole, Asenapine, Clozapine, Lurasidone, Olanzapine, Paliperidone, Quetiapine, Risperidone, Sertindole...
- 2\. Severe systemic infection in the early stage of resuscitation, hemodynamic instability or insufficient tissue perfusion, and severe imbalance of...
- 3\. Patients with a high risk of death within 5 days as judged by the clinician, or those whose treatment decisions are restricted.
- 4\. Active major gastrointestinal bleeding, perforation, or other severe damage to the intestinal barrier.
See the full eligibility criteria
- 1\. Age ≥ 18 years old, no ethnic or gender restrictions;
- 2\. CAM-ICU-positive delirium;
- 3\. Expected ICU stay ≥ 5 days after inclusion in the study;
- 4\. Signed written informed consent.
- 1\. Routine administration of antipsychotic medications: Conventional antipsychotic therapy refers to the daily ingestion or application of any sustained-release formulation (in any dosage form) of antipsychotic drugs...
- Typical antipsychotics: Chlorprothixene, Flupentixol, Haloperidol, Levomepromazine, Loxapine, Melperone, Perphenazine, Pericyazine, Pimozide, Prochlorperazine, Zuclopenthixol, Pimavanserin, Sulpiride.
- Atypical antipsychotics: Amisulpride, Aripiprazole, Asenapine, Clozapine, Lurasidone, Olanzapine, Paliperidone, Quetiapine, Risperidone, Sertindole, Ziprasidone. However, the non-habitual administration of antipsychotic...
- 2\. Severe systemic infection in the early stage of resuscitation, hemodynamic instability or insufficient tissue perfusion, and severe imbalance of water, electrolyte and acid-base.
- 3\. Patients with a high risk of death within 5 days as judged by the clinician, or those whose treatment decisions are restricted.
- 4\. Active major gastrointestinal bleeding, perforation, or other severe damage to the intestinal barrier.
- 5\. Patients who cannot tolerate 50% of their caloric requirements through enteral nutrition due to severe diarrhea, significant fibrotic intestinal stenosis, severe gastrointestinal bleeding, or high-flow enteric...
- 6\. Planned or recent abdominal surgery (within 14 days).
- 7\. Currently diagnosed with fulminant colitis or toxic megacolon.
- 8\. Recently received high-risk immunosuppressive or cytotoxic drug treatment: such as rituximab, doxorubicin, or medium to high-dose corticosteroids (20 mg/d prednisone or higher) for more than 4 weeks.
- 9\. Pregnant or lactating women.
- 10\. Participated in other clinical trials as a subject within the past 3 months or at the time of enrollment.
- 11\. Delirium assessment non applicable: this includes language barriers (patients with foreign language where delirium assessment cannot be confidently performed by the site staff), patients who are deaf, blind or...
- 12\. Doubtful validity of informed consent: people with mental illness, intellectual disability, poor motivation, or other factors that limit the validity of informed consent for participation in this study.
The study team makes the final eligibility decision.
Where it's taking place
- Wuhan, China
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Wuhan, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.