EpilepsyPhase 2/3NCT02889627
Fecal Microbiota Transplantation for Epilepsy
A Phase 2/3 study testing Fecal microbiota suspension in people with Epilepsy, run by The Second Hospital of Nanjing Medical University at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 3 to 60 years
- Conditions the study is for
- Epilepsy
- What is being tested?
- Fecal microbiota suspension
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- Nov 2016to Dec 2025
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 60 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- had been diagnosed with epilepsy for at least three months; experienced at least one seizure during the three months before WMT ;
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Medical Center for Digestive Diseases, The Second Affiliated Hospital of Nanjing Medical University
Nanjing, Jiangsu, 210011
Faming Zhang, MD, PhD, 086-25-58509883, fzhang@njmu.edu.cn
About this study
Official title: Efficacy and Safety of Fecal Microbiota Transplantation for Epilepsy
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.
Read the 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
- Being tested
- Fecal microbiota suspension
- Keywords
- Fecal Microbiota Transplantation, Gut microbiota, Brain-gut axis, Epilepsy
- Medical subject headings
- Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fecal microbiota suspensionDrug
Also called Washed fecal microbiota
The prepared microbiota suspension was infused into the participates' mid-gut or lower gut.
| Study group | Role | What they receive |
|---|---|---|
| FMT with microbiota suspension | Experimental | Participants undergo repeated FMT with ~50ml microbiota suspension. Receives: Drug: Fecal microbiota suspension |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of the seizures
the rates of patients who achieved a ≥50% reduction in seizure frequency from baseline to one month after WMT
Measured: 3months
Secondary outcomes (2)
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.
Measured: baseline, 1 week-post-FMT, 1 months-post-FMT, 3 months-post-FMT
Adverse events
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 after FMT.
Measured: 3months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2016 (estimated)
- Study startNov 2016
- Primary completionOct 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for EpilepsyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Second Hospital of Nanjing Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Faming Zhang, The Second Hospital of Nanjing Medical University
- Investigators
- Faming Zhang, MD,PhD, Principal investigator, The Second Hospital of Nanjing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02889627
- Sponsor's protocol ID
- Epilepsy-CN-160816
- Status last verified
- Dec 2023
- First submitted
- 16 Aug 2016
- Last updated
- 20 Mar 2024
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 24315484Borody 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.
PubMed 22183182Cui 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.
PubMed 26939622Li Q, He R, Wang X, Long C, He Z, Zhang S, Liu Y, Zhang Z, Wu J, Sun G, Cui B, Zhao F, Zhang F. Akkermansia muciniphila enhances washed microbiota transplantation in the treatment of epilepsy. Chin Med J (Engl). 2026 Jul 20. doi: 10.1097/CM9.0000000000004146. Online ahead of print.
PubMed 42473187
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Fecal Microbiota Transplantation for Epilepsy
- ClinicalTrials.gov ID
- NCT02889627
- Acronym / sponsor ID
- Epilepsy-CN-160816
- Conditions
- Epilepsy
- Keywords
- Fecal Microbiota Transplantation, Gut microbiota, Brain-gut axis, Epilepsy
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- The Second Hospital of Nanjing Medical UniversityUniversity, hospital or other
- Study start
- Nov 2016 (actual)
- Primary completion
- Oct 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 5 Sep 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| FMT with microbiota suspension | Experimental | Drug: Fecal microbiota suspensionParticipants undergo repeated FMT with ~50ml microbiota suspension. |
Who may qualify
- Ages
- 3 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- had been diagnosed with epilepsy for at least three months; experienced at least one seizure during the three months before WMT ;
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fecal microbiota suspensionAlso: Washed fecal microbiotaThe prepared microbiota suspension was infused into the participates' mid-gut or lower gut. | Drug | FMT with microbiota suspension |
Primary outcome
Frequency of the seizures
Time frame: 3months
the rates of patients who achieved a ≥50% reduction in seizure frequency from baseline to one month after WMT
2 secondary outcomes
gut microbiota analysis
Time frame: baseline, 1 week-post-FMT, 1 months-post-FMT, 3 months-post-FMT
Adverse events
Time frame: 3months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2024.
- Background: PubMed 24315484Hsiao 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.
- Background: PubMed 22183182Borody 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.
- Background: PubMed 26939622Cui 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.
- Derived from this study: PubMed 42473187Li Q, He R, Wang X, Long C, He Z, Zhang S, Liu Y, Zhang Z, Wu J, Sun G, Cui B, Zhao F, Zhang F. Akkermansia muciniphila enhances washed microbiota transplantation in the treatment of epilepsy. Chin Med J (Engl). 2026 Jul 20. doi: 10.1097/CM9.0000000000004146. Online ahead of print.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Faming Zhang, MD,PhD principal investigator
The Second Hospital of Nanjing Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Fecal microbiota suspension in people with Epilepsy, run by The Second Hospital of Nanjing Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Faming Zhang, MD,PhD (086-25-58509883, fzhang@njmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frequency of the seizures (time frame: 3months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02889627, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Mar 2024.