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Randomized controlled clinical study of fecal bacteria transplantation for autoimmune encephalitis

Randomized controlled clinical study of fecal bacteria transplantation for autoimmune encephalitis

Status
Recruiting
Phases
Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200065252
Enrollment
Unknown
Registered
2022-11-01
Start date
2022-11-01
Completion date
Unknown
Last updated
2023-05-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Autoimmune encephalitis

Interventions

Experimental group:fecal bacteria transplantation+conventional therapy
Conrol group:conventional therapy

Sponsors

Affiliated Hospital of Guangdong Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 55 Years

Inclusion criteria

Inclusion criteria: (1) Patients with confirmed autoimmune encephalitis who meet the enrollment criteria. (2) 18 years old <= age <=55 years old, signed and dated written informed consent.

Exclusion criteria

Exclusion criteria: (1) Patients with a diagnosis of human immunodeficiency virus (HIV) infection, brain abscess, viral disease, cerebral malaria, brain tumor, or non-infectious CNS disease (e.g., acute demyelinating encephalomyelitis (ADEM)). (2) Patients with CNS infection with viruses, bacteria, fungi, parasites, or Mycobacterium tuberculosis (TB) (3) Patients with sepsis or systemic inflammatory response syndrome secondary to encephalopathy; patients diagnosed with epilepsy, traumatic brain injury, and/or other neurological disorders prior to the onset of encephalitis (4) Pregnant, lactating women or those who intend to become pregnant in the near future (5) Those who do not agree to sign the patient's informed consent. (6) Participated in another clinical trial within 30 days prior to the date informed consent was obtained, or is participating in another clinical trial; other conditions that, in the opinion of the investigator, make participation in this clinical trial inappropriate. (7) Taking probiotics within 1 month.

Design outcomes

Primary

MeasureTime frame
Incidence of cognitive impairment at 24 weeks;

Countries

Chain

Contacts

Public ContactHaihong Zhou

Affiliated Hospital of Guangdong Medical University

doctorzhh1201@126.com+86 13729001536

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026