Poop pills to treat brain fog in the ICU?
NCT ID NCT07348471
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study tests whether fecal microbiota transplantation (FMT) can help treat delirium in intensive care unit (ICU) patients. Delirium is a sudden confusion that affects up to 80% of ICU patients and has no proven drug treatment. The trial will give 60 patients either standard care or FMT via a feeding tube for three days, and track how many days they are free of delirium.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- fecal microbiota transplantation (FMT)
- What this could lead to
- If it works, this could offer a new treatment for ICU delirium, a common and serious complication with no proven drug therapy.
- What could go wrong
- This is a small, early-stage trial with only 60 participants, so results may not apply widely. FMT also carries risks like infection or allergic reaction.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
-
About 60 people
The number the study aims to enrol. It can still change while the study runs.
- Started
-
Mar 2026
- Expected to finish
-
Dec 2028
An estimate. End dates often move.
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 to 80 years
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion 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. Exclusion Criteria: * 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 with the ATC code N05A (in any form), including the following agents: 1. Typical antipsychotics: Chlorprothixene, Flupentixol, Haloperidol, Levomepromazine, Loxapine, Melperone, Perphenazine, Pericyazine, Pimozide, Prochlorperazine, Zuclopenthixol, Pimavanserin, Sulpiride. 2. Atypical antipsychotics: Amisulpride, Aripiprazole, Asenapine, Clozapine, Lurasidone, Olanzapine, Paliperidone, Quetiapine, Risperidone, Sertindole, Ziprasidone. However, the non-habitual administration of antipsychotic medications in the general ward prior to the patient's ICU admission (e.g., for the management of delirium) is deemed acceptable. Nevertheless, antipsychotic therapy should be discontinued upon the patient's ICU admission. * 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 fistula. * 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 aphasic. Comatose patients are not applicable for delirium assessment. Coma is defined by the following levels of consciousness: RASS -4 to -5. Further, RASS -3 may be considered as coma if this is the judgement of the treating physician. If a patient's coma is considered related to administration of sedative agents, an effort should be made to reduce or terminate the sedative treatment, according to the clinician's discretion. * 12\. Doubtful validity of informed consent: subjects with mental illness, intellectual disability, poor motivation, or other factors that limit the validity of informed consent for participation in this study.
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Delirium are added.
Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
-
The places running it
1 site. The list below names each one and where it is.
-
The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
-
A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
-
Department of Critical Care Medicine, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
RECRUITINGWuhan, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Could a quieter, dimmer ICU protect Patients' brains?
- Can a daily supplement shield the brain after delirium?
- Brain surgery delirium: can real-time monitoring protect older patients?
- Could daylight hold the key to preventing delirium?
- Can sensory therapy calm Dementia-Related agitation in hospitals?
- A new care routine aims to shield aging hearts and minds in the ICU