Neuromyelitis optica spectrum disease
Conditions
Interventions
Experimental group:Oral administration of "Conse" probiotic mixture for 24 weeks (1 sachet qd) + stable dose of corticosteroid (prednisone 5-10mg qd) and/or immunosuppressant maintenance therapy (long
Control group:Placebo orally for 24 weeks (1 sachet qd) + stable dose of corticosteroid (prednisone 5-10mg qd) and/or immunosuppressant maintenance therapy (long-term maintenance therapy)
Sponsors
The Affiliated Hospital of Guangdong Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: (1) Aged 18 to 65 years; (2) Confirmed diagnosis of NMOSD in accordance with the diagnostic criteria established by IPND in 2015; (3) >= 2 episodes in past 1 year, or >= 3 episodes in the past 2 years; (4) Have started maintenance therapy with stable doses of hormones or immunosuppressants before enrollment; (5) Immunofluorescence (CBA) based on cell transfection for the determination of AQP4-IgG(+); (6) EDSS score <= 6.5 points; (7) Voluntarily sign the informed consent form.
Exclusion criteria
Exclusion criteria: (1) Patients who received a dose of more than 20mg of prednisone per day or a dose equivalent to other glucocorticoids or a large fluctuation in the dose of hormones before enrollment; (2) Monoclonal antibody therapy within 1 month before enrollment; (3) Have a disease that interferes with clinical evaluation, such as disability (not due to NMOSD); (4) Patients with autoimmune deficiencies such as HIV infection; (5) Pregnant, lactating women or those who intend to become pregnant in the near future; (6) Those who have received antibiotic treatment or taken other probiotic drugs 30 days before enrollment; (7) Those who have not signed the patient's informed consent or refuse to cooperate; (8) Participated in other clinical trials within 30 days prior to the date of informed consent, or is participating in other clinical trials; (9) Other circumstances that are considered unsuitable by the investigator to participate in this clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Disease recurrence rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Expanded Disability Status Scale, EDSS scale;Modified Rankin Scale, mRS score;EuroQol Five Dimensions Questionnaire, EQ-5D-5L score;Peripheral blood AQP-4 antibody titers; | — |
Countries
China
Contacts
Public ContactHaihong Zhou
The Affiliated Hospital of Guangdong Medical University
Outcome results
None listed