Fecal microbiota transplantation from patients with autoimmune encephalitis modulates Th17 response and relevant behaviors in mice.
Hao Chen, Zhaoyu Chen, Liping Shen...
https://pubmed.ncbi.nlm.nih.gov/32821439Actively Recruiting
Phase Not Applicable
Age: 18Years +
All Genders
Healthy Volunteers
ID06584045
An Open Label Clinical Trial to Evaluate the Efficacy and Safety of Calculus Bovis Sativus (CBS) for Adult Encephalitis
Led by Tongji Hospital · Updated on 2025-04-08
250
Participants Needed
1
Research Sites
21 weeks
Total Duration
On this page
Sponsors
T
Tongji Hospital
Lead Sponsor
J
Jianmin Pharmaceutical Group Co., LTD.
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the use of Calculus Bovis Sativus (CBS), a traditional Chinese medicine, for adults with encephalitis, a condition involving inflammation of the brain. This trial focuses on both infectious and autoimmune encephalitis types, including anti-NMDAR and LGI-1 autoimmune encephalitis. CBS is thought to have neuroprotective and anti-inflammatory effects by influencing gut microbiota and the brain-gut connection, potentially improving symptoms like seizures, consciousness, and cognitive function. Participants are divided into groups receiving either general therapy plus CBS, general therapy alone, or CBS alone if healthy. CBS is given orally at 100 mg daily for 84 days. The study is open-label and non-randomized, with some participants being healthy volunteers receiving only CBS. This design allows comparison of CBS effects in encephalitis patients and healthy individuals. During the study, participants will be monitored for neurological and cognitive changes using tools like the Modified Rankin Scale and Clinical Assessment Scale in Autoimmune Encephalitis over 12 weeks. Brain imaging, EEG, and assessments of mental state, anxiety, depression, and quality of life will also be conducted. Safety evaluations include tracking adverse effects up to 14 weeks. The study lasts up to 14 weeks from treatment start, with assessments at multiple timepoints.
CONDITIONS
Brief Title
Efficacy and Safety of Calculus Bovis Sativus (CBS) for Adult Encephalitis (CBSinEncephalitis)
Who Can Participate
Age: 18Years +
All Genders
Healthy Volunteers
Eligibility Criteria
You may qualify if you...
- Adults aged 18 to 80 years who can understand the study, provide informed consent, and allow use of their health information
- Diagnosed with autoimmune encephalitis (all subtypes) based on clinical, lab, and antibody criteria
- Diagnosed with viral encephalitis with specific clinical and lab confirmation
- Healthy adults aged 18 or older without underlying diseases for the healthy cohort
- For females and males of childbearing potential: must use contraception during the study and for 30 days after last dose
- Stable neurological exam within 30 days before baseline
- Meet specific diagnostic and symptom criteria for NMDAR or LGI-1 encephalitis if applicable
You will not qualify if you...
- Significant cardiac, endocrine, hematologic, hepatic, immune, infectious, metabolic, pulmonary, neurological, psychiatric, renal, or other major diseases
- Untreated tumors or malignancies at baseline
- Other causes of symptoms like CNS infection, metabolic encephalopathy, epilepsy, or rare neurological disorders
- Herpes simplex encephalitis in the past 24 weeks
- Recent major surgery within 4 weeks before baseline (except minor outpatient surgeries)
- Planned surgery during study (except minor)
- Severe allergic reactions to study components
- History of malignant disease except certain skin cancers or remission over 5 years
- Significant gastrointestinal diseases or symptoms
- Recent blood, plasma, or platelet donation
- Active or recent suicidal ideation or attempts
- Significant lab abnormalities preventing safe participation
- Pregnant, lactating, or planning pregnancy during study and 3 months after
- Participation in another clinical trial within 90 days
- Hearing, vision, or language impairment that prevents cooperation with assessments
- Uncontrolled blood pressure or serious heart rhythm problems
- HIV positive or current hepatitis B or C infection
- Recent severe infections or vaccinations
- Contraindications to certain rescue therapies
- History of specific immune or radiation treatments
- Other investigator-determined reasons making participation unsafe or unsuitable
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - 12 weeks
Participants receive Calculus bovis sativus (CBS) orally at 100mg per day for 12 weeks to evaluate efficacy and safety for adult encephalitis.
Weekly visits for up to 12 weeks
Follow-up
Duration - 2 weeks after treatment
Participants are monitored for safety and adverse effects up to 14 weeks after treatment initiation.
Approximately 2 visits (in-person)
Trial Site Locations
Total: 1 location
1
Tongji Hospital affiliated to Tongji Medical College of Huazhong University of Science and Technology
Wuhan, Hubei, China, 430000
Actively Recruiting
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Research Team
K
Ke Shang, MD
K
Ke Shang, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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