Fecal Microbiota Transplantation for Epilepsy

NCT ID: NCT02889627

Last Updated: 2024-03-20

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-11-30
• Study Completion Date: 2025-12-31

Brief 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.

Detailed 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.

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Conditions

Epilepsy

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

FMT with microbiota suspension

Participants undergo repeated FMT with \~50ml microbiota suspension.

Group Type: EXPERIMENTAL

Fecal microbiota suspension

Intervention Type: DRUG

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

Interventions

Fecal microbiota suspension

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

Intervention Type: DRUG

Other Intervention Names

Washed fecal microbiota

Eligibility Criteria

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

• Minimum Eligible Age: 3 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Second Hospital of Nanjing Medical University

OTHER

Sponsor Role: lead

Responsible Party

Faming Zhang

Associate professor, Gastroenterology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Faming Zhang, MD,PhD

Role: PRINCIPAL_INVESTIGATOR

The Second Hospital of Nanjing Medical University

Locations

Medical Center for Digestive Diseases, The Second Affiliated Hospital of Nanjing Medical University

Nanjing, Jiangsu, China

Site Status: RECRUITING

Countries

China

Central Contacts

Faming Zhang, MD,PhD

Role: CONTACT

fzhang@njmu.edu.cn

086-25-58509883

Facility Contacts

Faming Zhang, MD, PhD

Role: primary

fzhang@njmu.edu.cn

086-25-58509883

References

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.

Reference Type: BACKGROUND

PMID: 24315484 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 22183182 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 26939622 (View on PubMed)

Other Identifiers

Epilepsy-CN-160816

Identifier Type: -

Identifier Source: org_study_id