DepressionNCT05850572
A Study of the Efficacy of Fecal Microbiota Transplantation(FMT) in the Treatment of Depression
A study testing Fecal microbiota transplantation(FMT) in people with Depression, run by First Affiliated Hospital Xi'an Jiaotong University.
Trial summary
Patients with depression were enrolled and randomly divided into two groups, namely FMT combined with antidepressant group and Antidepressant alone group.The former received FMT capsules and antidepressants, and the latter received oral placebo and antidepressants for an 8-week intervention.Before and after… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Depression
- 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 first-episode depression who met the International Classification of Diseases(ICD)-10 diagnosis of depression
- Hamilton Depression Scale (HAMD) score ≥17
- Informed consent was obtained.
Who cannot join
- Use of antibiotics within 1 month
- Women are pregnant and lactating
- Patients with severe unstable cardiovascular disease, liver disease, kidney disease, etc
- Patients with malignant tumor or serious systemic disease
- Suffering from other mental disorders such as bipolar disorder, obsessive-compulsive disorder
- 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, and radiation enteritis
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 Antidepressants to Improve the Efficacy in Patients With Depressive Disorder
Patients with depression were enrolled and randomly divided into two groups, namely FMT combined with antidepressant group and Antidepressant alone group.The former received FMT capsules and antidepressants, and the latter received oral placebo and antidepressants for an 8-week intervention.Before and after intervention, venous blood samples were collected from patients for routine tests such as liver and kidney function to judge the safety of treatment. At the same time, psychological scales were used to evaluate the improvement of patients' depressive symptoms, so as to judge the efficacy and safety of FMT combined with antidepressants.
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 depression by recruiting patients with first episode depression and randomly administering FMT combined with antidepressants or placebo combined with antidepressants.
In this study, patients with first episode depression were randomly divided into two groups. The first group was the experimental group, and FMT capsules (10^12 colony forming unit(CFU)/ capsule) were used in addition to conventional antidepressant therapy. The other group, a control group, was given placebo capsules with the same color, look and smell as the FMT capsules in addition to regular antidepressant therapy. Placebo capsules contain Lactobacillus probiotics for food use (10^12 CFU/ capsule). The changes of depressive symptoms and adverse reactions before and after treatment were observed in the two groups to explore the efficacy and safety of FMT capsule in the adjuvant treatment of depression.
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 could use new selective serotonin reuptake inhibitors(SSRI)(fluoxetine, citalopram, escitalopram, Sertraline, paroxetine and fluvoxamine) recommended by current treatment guidelines, and the effective therapeutic dose of the drugs was added within 1 week. If, during the 8 weeks of the treatment period, the patient experienced significant fluctuations or severe adverse events that necessitates a change in antidepressant class, the study was terminated.
Benzodiazepines and medications that ameliorate side effects of antidepressants were allowed during the study period. Antipsychotics and mood stabilizers were prohibited. Electronic biofeedback therapy was allowed during the study, and transcranial magnetic stimulation and electroconvulsive non-convulsive therapy were prohibited.
- Conditions
- Depression
- Being tested
- Fecal microbiota transplantation(FMT), Placebo
- Medical subject headings
- Depression
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 CFU/capsule) in addition to their usual antidepressant treatment. Subjects will continue to receive FMT capsules for 8 weeks. New SSRI antidepressants (fluoxetine, citalopram, escitalopram, sertraline, paroxetine, and fluvoxamine) recommended by current treatment guidelines can be used during this period, and the effective therapeutic dose of the drugs can be added within 1 week.
PlaceboOther
Participants will receive a placebo capsule with the same color, appearance, and smell as the FMT capsule, in addition to their usual antidepressant treatment. Placebo capsules contained the food probiotic Lactobacillus (10^12 CFU per capsule). Subjects will continue to receive placebo capsules for 8 weeks. New SSRI antidepressants (fluoxetine, citalopram, escitalopram, sertraline, paroxetine, and fluvoxamine) recommended by current treatment guidelines can be used during this period, and the effective therapeutic dose of the drugs can be added within 1 week.
| Study group | Role | What they receive |
|---|---|---|
| Fecal microbiota transplantation(FMT) | Experimental | Subjects will receive FMT capsules (10^12 CFU/capsule) in addition to their usual antidepressant treatment. Subjects will continue to receive FMT capsules for 8 weeks. New SSRI antidepressants (fluoxetine, citalopram, escitalopram, sertraline, paroxetine, and fluvoxamine) recommended by current treatment guidelines can be used during this period, and the effective therapeutic dose of the drugs can be added within 1 week. 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 antidepressant treatment. Placebo capsules contained the food probiotic Lactobacillus (10^12 CFU per capsule). Subjects will continue to receive placebo capsules for 8 weeks. New SSRI antidepressants (fluoxetine, citalopram, escitalopram, sertraline, paroxetine, and fluvoxamine) recommended by current treatment guidelines can be used during this period, and the effective therapeutic dose of the drugs can be added within 1 week. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hamilton Depression Scale
Hamilton Depression Scale (HAMD) is the most commonly used scale in clinical depression assessment. The minimum and maximum values of HAMD were 0 and 24; Higher scores mean a worse outcome.
Measured: At the beginning of treatment
Hamilton Depression Scale
Hamilton Depression Scale (HAMD) is the most commonly used scale in clinical depression assessment. The minimum and maximum values of HAMD were 0 and 24; Higher scores mean a worse outcome.
Measured: At the end of 4 weeks
Hamilton Depression Scale
Hamilton Depression Scale (HAMD) is the most commonly used scale in clinical depression assessment. The minimum and maximum values of HAMD were 0 and 24; Higher scores mean a worse outcome.
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 DepressionStudies 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
- NCT05850572
- Sponsor's protocol ID
- 82022023-1
- Other IDs
- 2021GXLH-Z-083-1
- Status last verified
- Apr 2023
- First submitted
- 12 Apr 2023
- Last updated
- 30 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 30 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 Antidepressants to Improve the Efficacy in Patients With Depressive Disorder
- ClinicalTrials.gov ID
- NCT05850572
- Acronym / sponsor ID
- 82022023-1
- Conditions
- Depression
- 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.
Patients with depression were enrolled and randomly divided into two groups, namely FMT combined with antidepressant group and Antidepressant alone group.The former received FMT capsules and antidepressants, and the latter received oral placebo and antidepressants for an 8-week intervention.Before and after intervention, venous blood samples were collected from patients for routine tests such as liver and kidney function to judge the safety of treatment. At the same time, psychological scales were used to evaluate the improvement of patients' depressive symptoms, so as to judge the efficacy and safety of FMT combined with antidepressants.
Detailed description
The main research content of this project is to observe the efficacy and safety of adjuvant FMT capsules in the treatment of depression by recruiting patients with first episode depression and randomly administering FMT combined with antidepressants or placebo combined with antidepressants.
In this study, patients with first episode depression were randomly divided into two groups. The first group was the experimental group, and FMT capsules (10^12 colony forming unit(CFU)/ capsule) were used in addition to conventional antidepressant therapy. The other group, a control group, was given placebo capsules with the same color, look and smell as the FMT capsules in addition to regular antidepressant therapy. Placebo capsules contain Lactobacillus probiotics for food use (10^12 CFU/ capsule). The changes of depressive symptoms and adverse reactions before and after treatment were observed in the two groups to explore the efficacy and safety of FMT capsule in the adjuvant treatment of depression.
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 could use new selective serotonin reuptake inhibitors(SSRI)(fluoxetine, citalopram, escitalopram, Sertraline, paroxetine and fluvoxamine) recommended by current treatment guidelines, and the effective therapeutic dose of the drugs was added within 1 week. If, during the 8 weeks of the treatment period, the patient experienced significant fluctuations or severe adverse events that necessitates a change in antidepressant class, the study was terminated.
Benzodiazepines and medications that ameliorate side effects of antidepressants were allowed during the study period. Antipsychotics and mood stabilizers were prohibited. Electronic biofeedback therapy was allowed during the study, and transcranial magnetic stimulation and electroconvulsive non-convulsive therapy were 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 CFU/capsule) in addition to their usual antidepressant treatment. Subjects will continue to receive FMT capsules for 8 weeks. New SSRI antidepressants (fluoxetine, citalopram, escitalopram, sertraline, paroxetine, and fluvoxamine) recommended by current treatment guidelines can be used during this period, and the effective therapeutic dose of the drugs can be added within 1 week. |
| 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 antidepressant treatment. Placebo capsules contained the food probiotic Lactobacillus (10^12 CFU per capsule). Subjects will continue to receive placebo capsules for 8 weeks. New SSRI antidepressants (fluoxetine, citalopram, escitalopram, sertraline, paroxetine, and fluvoxamine) recommended by current treatment guidelines can be used during this period, and the effective therapeutic dose of the drugs can be added within 1 week. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Aged from 18 to 65 years
- Patients with first-episode depression who met the International Classification of Diseases(ICD)-10 diagnosis of depression
- Hamilton Depression Scale (HAMD) score ≥17
- Informed consent was obtained.
Key exclusion criteria (6 listed)
- Use of antibiotics within 1 month
- Women are pregnant and lactating
- Patients with severe unstable cardiovascular disease, liver disease, kidney disease, etc
- Patients with malignant tumor or serious systemic disease
- Suffering from other mental disorders such as bipolar disorder, obsessive-compulsive disorder
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 CFU/capsule) in addition to their usual antidepressant treatment. Subjects will continue to receive FMT capsules for 8 weeks. New SSRI antidepressants (fluoxetine, citalopram, escitalopram, sertraline, paroxetine, and fluvoxamine) recommended by current treatment guidelines can be used during this period, and the effective therapeutic dose of the drugs can be added within 1 week. | 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 antidepressant treatment. Placebo capsules contained the food probiotic Lactobacillus (10^12 CFU per capsule). Subjects will continue to receive placebo capsules for 8 weeks. New SSRI antidepressants (fluoxetine, citalopram, escitalopram, sertraline, paroxetine, and fluvoxamine) recommended by current treatment guidelines can be used during this period, and the effective therapeutic dose of the drugs can be added within 1 week. | Other | Placebo |
Primary outcome
Hamilton Depression Scale
Time frame: At the beginning of treatment
Hamilton Depression Scale (HAMD) is the most commonly used scale in clinical depression assessment. The minimum and maximum values of HAMD were 0 and 24; Higher scores mean a worse outcome.
Hamilton Depression Scale
Time frame: At the end of 4 weeks
Hamilton Depression Scale (HAMD) is the most commonly used scale in clinical depression assessment. The minimum and maximum values of HAMD were 0 and 24; Higher scores mean a worse outcome.
Hamilton Depression Scale
Time frame: At the end of 8 weeks
Hamilton Depression Scale (HAMD) is the most commonly used scale in clinical depression assessment. The minimum and maximum values of HAMD were 0 and 24; Higher scores mean a worse outcome.
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 30 May 2023.
Related trials for Depression
Recruiting
Unified Protocol in Penitentiary Facilities
Depression Disorders, Anxiety
Not yet recruiting
Preventive and Personalized Digital Emotion Regulation Skills Intervention to Reduce Depression and Anxiety in Youths With Adverse Childhood Experiences
Adverse Childhood Experience, Depression / Major Depressive Disorder
Not yet recruitingObservational study
Functional Impact of Psychological Symptoms in Patients With Superior Semicircular Canal Dehiscence Syndrome (SSCD): a National Cross-sectional Study
Superior Semicircular Canal Dehiscence
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
Recruiting
Cultural Adaptation of an Online Parenting Intervention to Reduce the Risk of Depression and Anxiety in Adolescents
Risk of Depression and Anxiety
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 Depression, 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 4 inclusion and 6 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 30 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?
Hamilton Depression Scale (time frame: At the beginning of treatment). 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 30 May 2023.