Neural Circuit Mechanism of Inflammatory Bowel Disease Combined With Depression (NCMOIBDCWD)
June 23, 2024 updated by: Jun Wang, LanZhou University
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.
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
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 Type
Observational
Enrollment (Estimated)
100
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Jun Wang, Doctor
- Phone Number: +8618298366202
- Email: wangj20@lzu.edu.cn
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Sampling Method
Non-Probability Sample
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.
Description
Inclusion Criteria:
aged 18-65 years right-handed active disease (CDAI score ≥150, Mayo score >2).
Exclusion Criteria:
previous brain surgery those with severe and unstable physical diseases those with contraindications for MRI who cannot tolerate long-duration MRI examinations.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
CD
Crohn's disease
|
Perform brain diffusion imaging, magnetic resonance spectroscopy, and functional magnetic resonance imaging scans on all individuals
Treatment of disease groups (UC and CD) using prepared fecal microbiota transplantation solution
|
|
UC
ulcerative colitis
|
Perform brain diffusion imaging, magnetic resonance spectroscopy, and functional magnetic resonance imaging scans on all individuals
Treatment of disease groups (UC and CD) using prepared fecal microbiota transplantation solution
|
|
HC
healthy controls
|
Perform brain diffusion imaging, magnetic resonance spectroscopy, and functional magnetic resonance imaging scans on all individuals
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Magnetic resonance spectroscopy
Time Frame: 1 week before and 1 week after FMT
|
Changes in GABA content in the prefrontal lobe of the brain
|
1 week before and 1 week after FMT
|
|
Magnetic resonance spectroscopy
Time Frame: 1 week before and 1 week after FMT
|
Changes in alpha diversity and differential abundance of gut microbiota
|
1 week before and 1 week after FMT
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: Jun Wang, Doctor, The Second Hospital & Clinical Medical School, Lanzhou University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
July 1, 2024
Primary Completion (Estimated)
July 1, 2024
Study Completion (Estimated)
December 1, 2027
Study Registration Dates
First Submitted
June 18, 2024
First Submitted That Met QC Criteria
June 18, 2024
First Posted (Actual)
June 24, 2024
Study Record Updates
Last Update Posted (Actual)
June 25, 2024
Last Update Submitted That Met QC Criteria
June 23, 2024
Last Verified
June 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2024A-255
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
After the data collection is completed, the collected gut microbiota data will be shared
IPD Sharing Time Frame
Around December 31, 2026
IPD Sharing Access Criteria
Email the corresponding author with reasonable reasons for inquiry
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- CSR
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.