Fecal Microbiota Transplantation for Epilepsy

NCT02889627 | Unknown Phase 2 DMC

• 1 other identifier: Epilepsy-CN-160816
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Epilepsy

Keywords

Fecal Microbiota Transplantation; Gut microbiota; Brain-gut axis; Epilepsy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• gut microbiota analysis

  baseline, 1 week-post-FMT, 1 months-post-FMT, 3 months-post-FMT

• Adverse events

  3months

Study Arms (1)

FMT with microbiota suspension

EXPERIMENTAL

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

Drug: Fecal microbiota suspension

Interventions

Fecal microbiota suspension DRUG

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

Also known as: Washed fecal microbiota

FMT with microbiota suspension

Eligibility Criteria

• Age: 3 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• The Second Hospital of Nanjing Medical University: lead

Study Sites (1)

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

Nanjing, Jiangsu, 210011, China

RECRUITING

Related Publications (3)

• 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.

  PMID: 24315484 BACKGROUND

• 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.

  PMID: 22183182 BACKGROUND

• 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.

  PMID: 26939622 BACKGROUND

MeSH Terms

Conditions

Epilepsy

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Faming Zhang, MD,PhD

  The Second Hospital of Nanjing Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Faming Zhang, MD,PhD

CONTACT

086-25-58509883; fzhang@njmu.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor, Gastroenterology

Study Record Dates

• First Submitted: August 16, 2016
• First Posted: September 5, 2016
• Study Start: November 1, 2016
• Primary Completion: October 1, 2025
• Study Completion: December 1, 2025
• Last Updated: March 20, 2024

Record last verified: 2023-12

Locations

CN (1)