Inflammatory Bowel DiseasesNCMOIBDCWDNCT06471894
Neural Circuit Mechanism of Inflammatory Bowel Disease Combined With Depression
An observational study of Inflammatory Bowel Diseases, run by LanZhou University.
Trial summary
The goal of this observational study is to understand the effects of gut microbiota dysbiosis treatment in patients with inflammatory bowel disease (IBD) combined with depression. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Inflammatory Bowel Diseases
- What is being tested?
- Magnetic resonance imaging scanning and FMT Protocol
- Type of treatment
- Surgery or procedure
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2024to 1 Dec 2027
- Phase
- Observational
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: The inflammatory bowel disease (IBD) combined with depression have increased psychological stress. Individuals with IBD often face prolonged physical discomfort and treatment challenges, which can lead to increased emotional burden and susceptibility to depression. IBD is a chronic condition requiring long-term management and treatment. These ongoing lifestyle changes and medical burdens may contribute to feelings of sadness and depression. In summary, depression is common among individuals with inflammatory bowel disease. It is important to monitor the mental health of patients during treatment and provide proactive psychological support and intervention when needed.
Who may be able to join
- aged 18-65 years right-handed active disease (CDAI score ≥150, Mayo score >2).
Who cannot join
- previous brain surgery those with severe and unstable physical diseases those with contraindications for MRI who cannot tolerate long-duration MRI examinations.
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: Study on the Neural Circuit Mechanism of Regulating GABA by Gut Microbiota in Inflammatory Bowel Disease Combined With Depression
The goal of this observational study is to understand the effects of gut microbiota dysbiosis treatment in patients with inflammatory bowel disease (IBD) combined with depression. The main question it aims to answer is:
Does fecal microbiota transplantation (FMT) improve depression symptoms in IBD patients by altering GABA levels in the medial prefrontal cortex?
Participants already undergoing fecal microbiota transplantation (FMT) as part of their regular medical care for IBD and comorbid depression will undergo regular assessments of GABA levels, gut microbiota, and depression symptoms for the duration of the study.
Read the detailed description
The high incidence of inflammatory bowel disease (IBD) combined with depression increases the risk of disease recurrence and treatment failure. Previous research by our team has found a positive correlation between decreased levels of the inhibitory neurotransmitter γ-aminobutyric acid (GABA) in the medial prefrontal cortex of IBD patients and the severity of depression. However, the underlying pathological mechanisms remain unknown. Prior studies have suggested that GABA regulates activity within neural circuits in the brain, and the levels of GABA in the brain are influenced by the gut microbiota. Based on this premise, our study aims to treat gut microbiota dysbiosis in IBD patients with comorbid depression using fecal microbiota transplantation (FMT). Our team will analyze the correlation between changes in GABA levels in the medial prefrontal cortex and gut microbiota using techniques such as metagenomics, metabolomics, and magnetic resonance spectroscopy imaging. Additionally, resting-state functional magnetic resonance imaging (fMRI) is used to perform dynamic causal modeling of the neural circuit in the brain to elucidate the regulatory mechanism of GABA level changes on these circuits. Finally, the investigators will validate the research findings using a dextran sulfate sodium (DSS)-induced colitis mouse model to explore the neurochemical mechanisms underlying IBD comorbid with depression. The results of this study will not only provide a deeper understanding of the regulatory role of changes in brain GABA levels on neural circuits but also offer a theoretical basis for the use of fecal microbiota transplantation in treating gut microbiota dysbiosis in IBD patients and prevent complications such as depression.
- Conditions
- Inflammatory Bowel Diseases
- Being tested
- Magnetic resonance imaging scanning, FMT Protocol
- Medical subject headings
- Inflammatory Bowel Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Magnetic resonance imaging scanningRadiation
Perform brain diffusion imaging, magnetic resonance spectroscopy, and functional magnetic resonance imaging scans on all individuals
FMT ProtocolDrug
Treatment of disease groups (UC and CD) using prepared fecal microbiota transplantation solution
| Study group | Role | What they receive |
|---|---|---|
| CD | Crohn's disease Receives: Radiation: Magnetic resonance imaging scanning; Drug: FMT Protocol | |
| UC | ulcerative colitis Receives: Radiation: Magnetic resonance imaging scanning; Drug: FMT Protocol | |
| HC | healthy controls Receives: Radiation: Magnetic resonance imaging scanning |
What is being measured
The primary outcome is the main question the study is designed to answer.
Magnetic resonance spectroscopy
Changes in GABA content in the prefrontal lobe of the brain
Measured: 1 week before and 1 week after FMT
Magnetic resonance spectroscopy
Changes in alpha diversity and differential abundance of gut microbiota
Measured: 1 week before and 1 week after FMT
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2024
- Study start1 Jul 2024 (estimated)
- Primary completion1 Jul 2024 (estimated)
- Study completion1 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inflammatory Bowel DiseasesStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- LanZhou University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jun Wang, LanZhou University
- Investigators
- Jun Wang, Doctor, Study chair, The Second Hospital & Clinical Medical School, Lanzhou University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06471894
- Sponsor's protocol ID
- 2024A-255
- Acronym
- NCMOIBDCWD
- Status last verified
- Jun 2024
- First submitted
- 18 Jun 2024
- Last updated
- 25 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: After the data collection is completed, the collected gut microbiota data will be shared
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on the Neural Circuit Mechanism of Regulating GABA by Gut Microbiota in Inflammatory Bowel Disease Combined With Depression
- ClinicalTrials.gov ID
- NCT06471894
- Acronym / sponsor ID
- NCMOIBDCWD / 2024A-255
- Conditions
- Inflammatory Bowel Diseases
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- LanZhou UniversityUniversity, hospital or other
- Study start
- 1 Jul 2024 (estimated)
- Primary completion
- 1 Jul 2024 (estimated)
- Study completion
- 1 Dec 2027 (estimated)
- First posted
- 24 Jun 2024 (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 goal of this observational study is to understand the effects of gut microbiota dysbiosis treatment in patients with inflammatory bowel disease (IBD) combined with depression. The main question it aims to answer is:
Does fecal microbiota transplantation (FMT) improve depression symptoms in IBD patients by altering GABA levels in the medial prefrontal cortex?
Participants already undergoing fecal microbiota transplantation (FMT) as part of their regular medical care for IBD and comorbid depression will undergo regular assessments of GABA levels, gut microbiota, and depression symptoms for the duration of the study.
Detailed description
The high incidence of inflammatory bowel disease (IBD) combined with depression increases the risk of disease recurrence and treatment failure. Previous research by our team has found a positive correlation between decreased levels of the inhibitory neurotransmitter γ-aminobutyric acid (GABA) in the medial prefrontal cortex of IBD patients and the severity of depression. However, the underlying pathological mechanisms remain unknown. Prior studies have suggested that GABA regulates activity within neural circuits in the brain, and the levels of GABA in the brain are influenced by the gut microbiota. Based on this premise, our study aims to treat gut microbiota dysbiosis in IBD patients with comorbid depression using fecal microbiota transplantation (FMT). Our team will analyze the correlation between changes in GABA levels in the medial prefrontal cortex and gut microbiota using techniques such as metagenomics, metabolomics, and magnetic resonance spectroscopy imaging. Additionally, resting-state functional magnetic resonance imaging (fMRI) is used to perform dynamic causal modeling of the neural circuit in the brain to elucidate the regulatory mechanism of GABA level changes on these circuits. Finally, the investigators will validate the research findings using a dextran sulfate sodium (DSS)-induced colitis mouse model to explore the neurochemical mechanisms underlying IBD comorbid with depression. The results of this study will not only provide a deeper understanding of the regulatory role of changes in brain GABA levels on neural circuits but also offer a theoretical basis for the use of fecal microbiota transplantation in treating gut microbiota dysbiosis in IBD patients and prevent complications such as depression.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| CD | – | Radiation: Magnetic resonance imaging scanning, Drug: FMT ProtocolCrohn's disease |
| UC | – | Radiation: Magnetic resonance imaging scanning, Drug: FMT Protocolulcerative colitis |
| HC | – | Radiation: Magnetic resonance imaging scanninghealthy controls |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The inflammatory bowel disease (IBD) combined with depression have increased psychological stress. Individuals with IBD often face prolonged physical discomfort and treatment challenges, which can lead to increased emotional burden and susceptibility to depression. IBD is a chronic condition requiring long-term management and treatment. These ongoing lifestyle changes and medical burdens may contribute to feelings of sadness and depression. In summary, depression is common among individuals with inflammatory bowel disease. It is important to monitor the mental health of patients during treatment and provide proactive psychological support and intervention when needed.
Key inclusion criteria (1 listed)
- aged 18-65 years right-handed active disease (CDAI score ≥150, Mayo score >2).
Key exclusion criteria (1 listed)
- previous brain surgery those with severe and unstable physical diseases those with contraindications for MRI who cannot tolerate long-duration MRI examinations.
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 |
|---|---|---|
| Magnetic resonance imaging scanningPerform brain diffusion imaging, magnetic resonance spectroscopy, and functional magnetic resonance imaging scans on all individuals | Radiation | CD, HC, UC |
| FMT ProtocolTreatment of disease groups (UC and CD) using prepared fecal microbiota transplantation solution | Drug | CD, UC |
Primary outcome
Magnetic resonance spectroscopy
Time frame: 1 week before and 1 week after FMT
Changes in GABA content in the prefrontal lobe of the brain
Magnetic resonance spectroscopy
Time frame: 1 week before and 1 week after FMT
Changes in alpha diversity and differential abundance of gut microbiota
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 25 Jun 2024.
- Individual participant dataSharing planned: Yes. After the data collection is completed, the collected gut microbiota data will be shared
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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.
Jun Wang, Doctor study chair
The Second Hospital & Clinical Medical School, Lanzhou University
Questions about this trial
What is this clinical trial studying?
An observational study of Inflammatory Bowel Diseases, run by LanZhou 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 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: opening soon, as of the sponsor's last update on 25 Jun 2024. 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. 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 Jun Wang, Doctor (+8618298366202, wangj20@lzu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Magnetic resonance spectroscopy (time frame: 1 week before and 1 week after FMT). The study lists 2 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 25 Jun 2024; AzTrials last refreshed its copy on 8 Nov 2026.