Fecal Microbiota Transplantation for Epilepsy

Epilepsy Clinical Trial

Official title:

Efficacy and Safety of Fecal Microbiota Transplantation for Epilepsy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02889627
• Other study ID #: Epilepsy-CN-160816
• Status: Recruiting
• Phase: Phase 2/Phase 3
• Start date: November 2016
• Est. completion date: December 2025

Study information

• Verified date: December 2023
• Source: The Second Hospital of Nanjing Medical University
• Contact: Faming Zhang, MD,PhD
• Phone: 086-25-58509883
• Email: fzhang[@]njmu.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Increasing evidences showed the microbiota effects on neuropsychiatric disorders. This clinical trial aims to evaluate the efficacy and safety of fecal microbiota transplantation for epilepsy.

Description:

Very few literatures reported the clinical use of microbiota or bacteria for brain diseases. The most effective strategy for reconstruction of gut microbiota should be fecal microbiota transplantation (FMT). This study aims to evaluate the efficacy and safety of FMT for epilepsy. Patients were diagnosed as epilepsy by electroencephalogram (EEG) and MRI and clinical data when the study began and thent received repeated FMT with fecal from healthy donors.The antiepileptic medication regimen of patients remained unchanged after FMT. The primary outcome measure was the frequency of the seizures. Secondary outcome measure were the 50% response rate.

.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: December 2025
• Est. primary completion date: October 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Years to 60 Years

Eligibility

Inclusion Criteria:

had been diagnosed with epilepsy for at least three months; experienced at least one seizure during the three months before WMT ;

Exclusion Criteria:

had other severe diseases, including other intestinal disorders (e.g., Clostridioides difficile infection), malignant neoplasm, cardiopulmonary failure or serious liver or kidney disease, had undergone previous FMT or WMT, had taken antibiotics within three months before starting WMT

Related Conditions & MeSH terms

• Epilepsy

Intervention

Drug:
• Fecal microbiota suspension
The prepared microbiota suspension was infused into the participates' mid-gut or lower gut.

Locations

Country	Name	City	State
China	Medical Center for Digestive Diseases, The Second Affiliated Hospital of Nanjing Medical University	Nanjing	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
The Second Hospital of Nanjing Medical University

Country where clinical trial is conducted

China, 

References & Publications (3)

Borody TJ, Khoruts A. Fecal microbiota transplantation and emerging applications. Nat Rev Gastroenterol Hepatol. 2011 Dec 20;9(2):88-96. doi: 10.1038/nrgastro.2011.244. — View Citation

Cui B, Li P, Xu L, Peng Z, Xiang J, He Z, Zhang T, Ji G, Nie Y, Wu K, Fan D, Zhang F. Step-up fecal microbiota transplantation (FMT) strategy. Gut Microbes. 2016 Jul 3;7(4):323-328. doi: 10.1080/19490976.2016.1151608. Epub 2016 Mar 3. Erratum In: doi: 10.1186/s12967-015-0646-2. — View Citation

Hsiao EY, McBride SW, Hsien S, Sharon G, Hyde ER, McCue T, Codelli JA, Chow J, Reisman SE, Petrosino JF, Patterson PH, Mazmanian SK. Microbiota modulate behavioral and physiological abnormalities associated with neurodevelopmental disorders. Cell. 2013 Dec 19;155(7):1451-63. doi: 10.1016/j.cell.2013.11.024. Epub 2013 Dec 5. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Frequency of the seizures	the rates of patients who achieved a =50% reduction in seizure frequency from baseline to one month after WMT	3months
Secondary	gut microbiota analysis	The stool samples of participants before and after FMT were collected and analized, by 16S rRNA and were used to investigate the crucial microbiota for devising a more efficient treatment strategy for epilepsy.	baseline, 1 week-post-FMT, 1 months-post-FMT, 3 months-post-FMT
Secondary	Adverse events	Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 after FMT.	3months