SchizophreniaNCT05850585
A Study of the Efficacy of Fecal Microbiota Transplantation(FMT) in the Treatment of Schizophrenia
A study testing Fecal microbiota transplantation(FMT) in people with Schizophrenia, run by First Affiliated Hospital Xi'an Jiaotong University.
Trial summary
The purpose of this study was to explore whether repeated oral fecal capsules could improve outcomes in patients with schizophrenia receiving conventional antipsychotic drugs. This study was divided into screening period (1 week) and treatment period (8 weeks). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Schizophrenia
- What is being tested?
- Fecal microbiota transplantation(FMT)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- Jul 2023to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged from 18 to 65 years
- Patients with schizophrenia and a disease duration of 5 years or less are currently receiving first-line recommended antipsychotic medications
- The patients met the diagnostic criteria of schizophrenia in the 10th edition of the International Classification of Diseases (ICD-10)
- Positive and Negative Syndrome Scale (PANSS) : total score ≥60 (at least 3 positive items ≥3 or 3 negative items ≥3)
- Junior high school or above
- Subjects provided informed consent
Who cannot join
- Pregnant and lactating women
- Clinically significant or unstable medical diseases, including congestive heart failure, liver and kidney failure, cancer, immune and metabolic endocrine diseases
- Or hepatobiliary gastrointestinal diseases, abdominal pain, diarrhea (except functional constipation)
- Those who had acute or chronic infection, had taken anti-inflammatory drugs, cortisol hormones, and had received antibiotics in the past month
- Other neuropsychiatric disorders (patients with organic brain lesions, mental disorders and mental retardation caused by physical diseases or psychoactive substances)
- There were those with fixed drinking habits
- It is accompanied by intestinal diseases that seriously damage the intestinal barrier, such as inflammatory bowel disease, Crohn's disease, intestinal tuberculosis, ischemic bowel disease, radiation enteritis, and intestinal infectious diseases
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Prospective, Double-blind, Randomized Controlled Trial of FMT Combined With Antipsychotic Drugs to Improve the Efficacy of Schizophrenia
The purpose of this study was to explore whether repeated oral fecal capsules could improve outcomes in patients with schizophrenia receiving conventional antipsychotic drugs. This study was divided into screening period (1 week) and treatment period (8 weeks). Subjects who met the inclusion criteria during the screening period entered the treatment period. During the treatment period, the patients were divided into two groups: oral fecal bacteria capsules + antipsychotics group; Oral placebo + antipsychotic group. During the follow-up period, both groups were treated with stable dose of antipsychotic drugs during the treatment period. Before and after the intervention, venous blood samples of patients were collected for routine tests such as liver and kidney function to determine the safety of treatment. The scale evaluated the improvement of patients' psychotic symptoms to determine the efficacy and safety of FMT combined with antipsychotics.
Read the detailed description
The main research content of this project is to observe the efficacy and safety of adjuvant FMT capsules in the treatment of schizophrenia by enrolling patients with schizophrenia and randomly administering FMT combined with antipsychotics or placebo combined with antipsychotics.
This is a multicenter, randomized, double-blind, placebo-controlled clinical trial. In this study, patients with schizophrenia were randomly divided into two groups. The first group was the experimental group, and FMT capsules (10^12 CFU/ capsule) were used in addition to conventional antipsychotic drugs. The other group, a control group, received a placebo pill with the same color, appearance and smell as the FMT capsules in addition to regular antipsychotic medication. Placebo capsules contain Lactobacillus probiotics for food use (10^12 CFU/ capsule). To observe the efficacy and safety of adjuvant FMT capsule in patients with schizophrenia.
The subjects (inpatients) were evaluated for meeting the eligibility requirements for this study according to the pre-specified inclusion and exclusion criteria, and demographic data (age, sex, marital status, educational level, employment, height and weight, smoking and drinking, and other general information as well as questionnaire assessment of eating habits) were collected. Improve laboratory examination (blood routine, liver function, kidney function and lipid), electrocardiogram and scale assessment.
Patients at the end of the screening period were randomly assigned to the experimental and control groups. Subjects will continue to receive FMT capsules or placebo capsules until the end of 8 weeks. During this period, both groups were given first-line atypical antipsychotics (clozapine, olanzapine, quintiapine, risperidone, aripiprazole, Ziprasidone, amsulapride, paliperidone, and paliperidone palmitate) recommended by current treatment guidelines, and added to the effective therapeutic dose within 1 week.
Benzodiazepines and drugs that ameliorate side effects of antipsychotics may be used during the study period. Antidepressants and mood stabilizers are prohibited. Transcranial magnetic stimulation and electronic biofeedback were allowed during the study, and non-convulsive electroconvulsive therapy was prohibited.
- Conditions
- Schizophrenia
- Being tested
- Fecal microbiota transplantation(FMT), Placebo
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fecal microbiota transplantation(FMT)Drug
Subjects will receive FMT capsules (10^12 Colony-Forming Units(CFU)/capsule) in addition to their usual antipsychotics treatment. Subjects will continue to receive FMT capsules for 8 weeks. During this period, both groups could receive first-line atypical antipsychotics recommended by current treatment guidelines.
PlaceboOther
Participants will receive a placebo capsule with the same color, appearance, and smell as the FMT capsule, in addition to their usual antipsychotics treatment. Placebo capsules contained the food probiotic Lactobacillus (10^12 CFU per capsule). Subjects will continue to receive placebo capsules for 8 weeks. During this period, both groups could receive first-line atypical antipsychotics recommended by current treatment guidelines.
| Study group | Role | What they receive |
|---|---|---|
| Fecal microbiota transplantation(FMT) | Experimental | Subjects will receive FMT capsules (10^12 Colony-Forming Units(CFU)/capsule) in addition to their usual antipsychotics treatment. Subjects will continue to receive FMT capsules for 8 weeks. During this period, both groups could receive first-line atypical antipsychotics recommended by current treatment guidelines. Receives: Drug: Fecal microbiota transplantation(FMT) |
| Placebo | Placebo comparator | Participants will receive a placebo capsule with the same color, appearance, and smell as the FMT capsule, in addition to their usual antipsychotics treatment. Placebo capsules contained the food probiotic Lactobacillus (10^12 CFU per capsule). Subjects will continue to receive placebo capsules for 8 weeks. During this period, both groups could receive first-line atypical antipsychotics recommended by current treatment guidelines. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Positive and Negative Syndrome Scale（PANSS）score
PANSS is a scale used to assess the psychotic symptoms of the client.This scale is evaluated by trained doctors, usually through conversation and observation, and scored after the examination. Score before and after treatment and during treatment can evaluate the severity of the disease and treatment effect.
Measured: At the beginning of treatment, at 4 weeks and at the end of 8 weeks
Positive and Negative Syndrome Scale（PANSS）score
PANSS is a scale used to assess the psychotic symptoms of the client.This scale is evaluated by trained doctors, usually through conversation and observation, and scored after the examination. Score before and after treatment and during treatment can evaluate the severity of the disease and treatment effect.
Measured: at the end of 4 weeks
Positive and Negative Syndrome Scale（PANSS）score
PANSS is a scale used to assess the psychotic symptoms of the client.This scale is evaluated by trained doctors, usually through conversation and observation, and scored after the examination. Score before and after treatment and during treatment can evaluate the severity of the disease and treatment effect.
Measured: at the end of 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2023
- Study startJul 2023 (estimated)
- Primary completionDec 2025 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- More trials run by First Affiliated Hospital Xi'an Jiaotong UniversityThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Feng Zhu, professor, Study director, First Affiliated Hospital Xi'an Jiaotong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05850585
- Sponsor's protocol ID
- 82022023-2
- Other IDs
- 2021GXLH-Z-083-2
- Status last verified
- Apr 2023
- First submitted
- 12 Apr 2023
- Last updated
- 26 May 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Double-blind, Randomized Controlled Trial of FMT Combined With Antipsychotic Drugs to Improve the Efficacy of Schizophrenia
- ClinicalTrials.gov ID
- NCT05850585
- Acronym / sponsor ID
- 82022023-2
- Conditions
- Schizophrenia
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- First Affiliated Hospital Xi'an Jiaotong UniversityUniversity, hospital or other
- Study start
- Jul 2023 (estimated)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 9 May 2023 (actual)
- 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.
The purpose of this study was to explore whether repeated oral fecal capsules could improve outcomes in patients with schizophrenia receiving conventional antipsychotic drugs. This study was divided into screening period (1 week) and treatment period (8 weeks). Subjects who met the inclusion criteria during the screening period entered the treatment period. During the treatment period, the patients were divided into two groups: oral fecal bacteria capsules + antipsychotics group; Oral placebo + antipsychotic group. During the follow-up period, both groups were treated with stable dose of antipsychotic drugs during the treatment period. Before and after the intervention, venous blood samples of patients were collected for routine tests such as liver and kidney function to determine the safety of treatment. The scale evaluated the improvement of patients' psychotic symptoms to determine the efficacy and safety of FMT combined with antipsychotics.
Detailed description
The main research content of this project is to observe the efficacy and safety of adjuvant FMT capsules in the treatment of schizophrenia by enrolling patients with schizophrenia and randomly administering FMT combined with antipsychotics or placebo combined with antipsychotics.
This is a multicenter, randomized, double-blind, placebo-controlled clinical trial. In this study, patients with schizophrenia were randomly divided into two groups. The first group was the experimental group, and FMT capsules (10^12 CFU/ capsule) were used in addition to conventional antipsychotic drugs. The other group, a control group, received a placebo pill with the same color, appearance and smell as the FMT capsules in addition to regular antipsychotic medication. Placebo capsules contain Lactobacillus probiotics for food use (10^12 CFU/ capsule). To observe the efficacy and safety of adjuvant FMT capsule in patients with schizophrenia.
The subjects (inpatients) were evaluated for meeting the eligibility requirements for this study according to the pre-specified inclusion and exclusion criteria, and demographic data (age, sex, marital status, educational level, employment, height and weight, smoking and drinking, and other general information as well as questionnaire assessment of eating habits) were collected. Improve laboratory examination (blood routine, liver function, kidney function and lipid), electrocardiogram and scale assessment.
Patients at the end of the screening period were randomly assigned to the experimental and control groups. Subjects will continue to receive FMT capsules or placebo capsules until the end of 8 weeks. During this period, both groups were given first-line atypical antipsychotics (clozapine, olanzapine, quintiapine, risperidone, aripiprazole, Ziprasidone, amsulapride, paliperidone, and paliperidone palmitate) recommended by current treatment guidelines, and added to the effective therapeutic dose within 1 week.
Benzodiazepines and drugs that ameliorate side effects of antipsychotics may be used during the study period. Antidepressants and mood stabilizers are prohibited. Transcranial magnetic stimulation and electronic biofeedback were allowed during the study, and non-convulsive electroconvulsive therapy was prohibited.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fecal microbiota transplantation(FMT) | Experimental | Drug: Fecal microbiota transplantation(FMT)Subjects will receive FMT capsules (10^12 Colony-Forming Units(CFU)/capsule) in addition to their usual antipsychotics treatment. Subjects will continue to receive FMT capsules for 8 weeks. During this period, both groups could receive first-line atypical antipsychotics recommended by current treatment guidelines. |
| Placebo | Placebo comparator | Other: PlaceboParticipants will receive a placebo capsule with the same color, appearance, and smell as the FMT capsule, in addition to their usual antipsychotics treatment. Placebo capsules contained the food probiotic Lactobacillus (10^12 CFU per capsule). Subjects will continue to receive placebo capsules for 8 weeks. During this period, both groups could receive first-line atypical antipsychotics recommended by current treatment guidelines. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Aged from 18 to 65 years
- Patients with schizophrenia and a disease duration of 5 years or less are currently receiving first-line recommended antipsychotic medications
- The patients met the diagnostic criteria of schizophrenia in the 10th edition of the International Classification of Diseases (ICD-10)
- Positive and Negative Syndrome Scale (PANSS) : total score ≥60 (at least 3 positive items ≥3 or 3 negative items ≥3)
- Junior high school or above
Key exclusion criteria (7 listed)
- Pregnant and lactating women
- Clinically significant or unstable medical diseases, including congestive heart failure, liver and kidney failure, cancer, immune and metabolic endocrine diseases
- Or hepatobiliary gastrointestinal diseases, abdominal pain, diarrhea (except functional constipation)
- Those who had acute or chronic infection, had taken anti-inflammatory drugs, cortisol hormones, and had received antibiotics in the past month
- Other neuropsychiatric disorders (patients with organic brain lesions, mental disorders and mental retardation caused by physical diseases or psychoactive substances)
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 transplantation(FMT)Subjects will receive FMT capsules (10^12 Colony-Forming Units(CFU)/capsule) in addition to their usual antipsychotics treatment. Subjects will continue to receive FMT capsules for 8 weeks. During this period, both groups could receive first-line atypical antipsychotics recommended by current treatment guidelines. | Drug | Fecal microbiota transplantation(FMT) |
| PlaceboParticipants will receive a placebo capsule with the same color, appearance, and smell as the FMT capsule, in addition to their usual antipsychotics treatment. Placebo capsules contained the food probiotic Lactobacillus (10^12 CFU per capsule). Subjects will continue to receive placebo capsules for 8 weeks. During this period, both groups could receive first-line atypical antipsychotics recommended by current treatment guidelines. | Other | Placebo |
Primary outcome
Positive and Negative Syndrome Scale（PANSS）score
Time frame: At the beginning of treatment, at 4 weeks and at the end of 8 weeks
PANSS is a scale used to assess the psychotic symptoms of the client.This scale is evaluated by trained doctors, usually through conversation and observation, and scored after the examination. Score before and after treatment and during treatment can evaluate the severity of the disease and treatment effect.
Positive and Negative Syndrome Scale（PANSS）score
Time frame: at the end of 4 weeks
PANSS is a scale used to assess the psychotic symptoms of the client.This scale is evaluated by trained doctors, usually through conversation and observation, and scored after the examination. Score before and after treatment and during treatment can evaluate the severity of the disease and treatment effect.
Positive and Negative Syndrome Scale（PANSS）score
Time frame: at the end of 8 weeks
PANSS is a scale used to assess the psychotic symptoms of the client.This scale is evaluated by trained doctors, usually through conversation and observation, and scored after the examination. Score before and after treatment and during treatment can evaluate the severity of the disease and treatment effect.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 May 2023.
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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.
Feng Zhu, professor study director
First Affiliated Hospital Xi'an Jiaotong University
Questions about this trial
What is this clinical trial studying?
A study testing Fecal microbiota transplantation(FMT) in people with Schizophrenia, run by First Affiliated Hospital Xi'an Jiaotong University.
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 6 inclusion and 7 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: opening soon, as of the sponsor's last update on 26 May 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Feng Zhu, professor (0086-13571827380, zhufeng0714@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Positive and Negative Syndrome Scale（PANSS）score (time frame: At the beginning of treatment, at 4 weeks and at the end of 8 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 26 May 2023; AzTrials last refreshed its copy on 8 Nov 2026.