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Evaluation of safety and efficacy of Bacteroides fragilis BF839 in the adjuvant treatment of refractory epilepsy in children

Evaluation of safety and efficacy of Bacteroides fragilis BF839 in the adjuvant treatment of refractory epilepsy in children

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100042203
Enrollment
Unknown
Registered
2021-01-15
Start date
2021-02-01
Completion date
Unknown
Last updated
2021-04-19

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

Conditions

Epilepsy

Interventions

Sponsors

Shenzhen Children's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
1 Years to 18 Years

Inclusion criteria

Inclusion criteria: 1. Patients with drug-resistant epilepsy diagnosis; 2. Patients with epilepsy at least once a month; 3. Patients taking medicine regularly at present; 4. Subjects aged 1-18 years old; 5. Subjects who did not consider other non drug treatment regimens in the past six months.

Exclusion criteria

Exclusion criteria: 1. Subjects who had been treated with other probiotics within 30 days before inclusion in the study; 2. Subjects with chronic gastrointestinal diseases, liver or renal insufficiency, lactose intolerance, diarrhea, immunosuppressive diseases, long-term use of antibiotics, and severe psychiatric diseases; 3. Subjects who have participated in other epilepsy treatment related studies within 3 months; 4. Subjects who cannot follow up regularly.

Design outcomes

Primary

MeasureTime frame
Frequency of seizure;

Secondary

MeasureTime frame
Intestinal flora analysis;

Countries

China

Contacts

Public ContactCao Dezhi

Neurology Department of Shenzhen Children's Hospital

caodezhi888@aliyun.com+86 18938691158

Outcome results

None listed

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