Neural Circuit Mechanism of Inflammatory Bowel Disease Combined With Depression

NCT ID: NCT06471894

Last Updated: 2024-06-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-07-01

Study Completion Date

2027-12-01

Brief Summary

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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

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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

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Inflammatory Bowel Diseases

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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CD

Crohn's disease

Magnetic resonance imaging scanning

Intervention Type RADIATION

Perform brain diffusion imaging, magnetic resonance spectroscopy, and functional magnetic resonance imaging scans on all individuals

FMT Protocol

Intervention Type DRUG

Treatment of disease groups (UC and CD) using prepared fecal microbiota transplantation solution

UC

ulcerative colitis

Magnetic resonance imaging scanning

Intervention Type RADIATION

Perform brain diffusion imaging, magnetic resonance spectroscopy, and functional magnetic resonance imaging scans on all individuals

FMT Protocol

Intervention Type DRUG

Treatment of disease groups (UC and CD) using prepared fecal microbiota transplantation solution

HC

healthy controls

Magnetic resonance imaging scanning

Intervention Type RADIATION

Perform brain diffusion imaging, magnetic resonance spectroscopy, and functional magnetic resonance imaging scans on all individuals

Interventions

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Magnetic resonance imaging scanning

Perform brain diffusion imaging, magnetic resonance spectroscopy, and functional magnetic resonance imaging scans on all individuals

Intervention Type RADIATION

FMT Protocol

Treatment of disease groups (UC and CD) using prepared fecal microbiota transplantation solution

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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LanZhou University

OTHER

Sponsor Role lead

Responsible Party

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Jun Wang

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jun Wang, Doctor

Role: STUDY_CHAIR

The Second Hospital & Clinical Medical School, Lanzhou University

Central Contacts

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Jun Wang, Doctor

Role: CONTACT

+8618298366202

Other Identifiers

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2024A-255

Identifier Type: -

Identifier Source: org_study_id

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