Fecal microbiota transplant to treat ICU delirium

Fecal Microbiota Transplantation for the Treatment of ICU Delirium: An Investigator-Initiated, Prospective, Two-Arm, Single-Center, Non-Blinded, Randomized Controlled Trial

This trial will test whether transferring healthy gut bacteria (fecal microbiota transplantation) can help adults in the ICU who have delirium.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 60 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: Union Hospital, Tongji Medical College, Huazhong University of Science and Technology (Academic / other)
• Drugs / interventions: rituximab, doxorubicin, prednisone
• Locations: 1 site (Wuhan)
• Trial ID: NCT07348471 on ClinicalTrials.gov

What this trial studies

This interventional, single-center trial administers an intestinal microbiota suspension (fecal microbiota transplantation) to adult ICU patients with CAM-ICU–positive delirium who are expected to remain in the ICU at least five days. Key inclusion criteria are age ≥18, a positive CAM-ICU delirium assessment, and signed informed consent; routine long-term antipsychotic use and other contraindications are excluded. Participants will be monitored for changes in delirium duration, ICU and hospital length of stay, and short- to medium-term cognitive outcomes. The trial is conducted in the Department of Critical Care Medicine at Union Hospital, Tongji Medical College, Huazhong University of Science and Technology in Wuhan.

Who should consider this trial

Good fit: Adults (≥18 years) admitted to the ICU with CAM-ICU–positive delirium, expected to stay ≥5 days, not on routine antipsychotic therapy, and able to provide informed consent (or have a surrogate) are ideal candidates.

Not a fit: Patients already receiving routine antipsychotics, those with very short expected ICU stays, or with contraindications to fecal microbiota transplantation may not receive benefit from this intervention.

Why it matters

Potential benefit: If successful, this approach could shorten delirium episodes in the ICU and reduce the risk of persistent cognitive impairment after discharge.

How similar studies have performed: Fecal microbiota transplantation is well established for recurrent C. difficile infection and preclinical data link gut dysbiosis to brain dysfunction, but applying microbiota transfer specifically to ICU delirium is largely novel with limited prior human data.

Eligibility criteria

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.

Where this trial is running

Wuhan

• Department of Critical Care Medicine, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology — Wuhan, China (Recruiting)

Study contacts

• Study coordinator: Jiancheng Zhang

Conditions Delirium